Clinical trial NCT03408483
Conditions: Total Hip Arthroplasty
Keywords: Quadratus Lumborum Block
Sponsor: University of Alabama at Birmingham
Start date: 2018-04-01; Completion date: 2020-08-22
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Peripheral nerve blocks for joint and extremity surgeries have long been proven to provide effective post-operative analgesia. Of these surgeries, total hip arthroplasty (THA) remains one of the most common orthopedic procedures in the United States with approximately 300,000 operations performed annually. At our institution, post-operative analgesia in these patients is primarily provided through parenteral and oral opioid medications. Quadratus lumborum blocks (QLB) have been described and implemented for various surgical procedures including caesarean and laparoscopic ovarian surgery. Recently, there has been increasing interest in the efficacy of quadratus lumborum blocks for THA. Currently, case reports have established a precedent regarding the efficacy of the QLB for THA in providing superior analgesia and decreasing visual analog pain scores (VAS), but randomized trials are still lacking. The goal of this study is to compare pain scores (VAS), opioid consumption, physical therapy scores, and patient and surgeon satisfaction in patients that receive QLB versus no peripheral nerve blockade in patients undergoing THA. The results of this study have the potential to change standard of care for patients undergoing THA.

Detailed description:
Currently, regional anesthesia techniques for total hip arthroplasty are limited. Fascia iliac blocks have been employed to provide analgesia for hip surgeries with blockade of the femoral, lateral femoral cutaneous, and obturator nerves via injection of local anesthetic in the iliacus fascia. In addition, lumbar plexus blocks have also been employed for post-operative analgesia, but the complexity of the block is high, and complications including epidural anesthesia are not infrequent. The quadratus lumborum block is an abdominal truncal block in which local anesthetic is deposited into the thoracolumbar fascia or the quadratus lumborum muscle itself with the goal of providing analgesia to the ipsilateral T6 - L1 sensory dermatomes. It has already been demonstrated to provide effective post-operative analgesia for certain abdominal and pelvic surgeries, but its use in total hip arthroplasty is limited to case reports.

The block is accomplished by identifying the quadratus lumborum muscle, which originates from iliac crest and iliolumbar ligament, and inserted on transverse processes of upper four lumbar vertebrae and posterior border of the 12th rib. Local anesthetic is then deposited at the anterior, posterior or middle thoracolumbar fascia, or intramuscularly, depending on the technique used. Cadaveric studies8 have demonstrated dye spread to the lumbar nerve roots and nerves within the transversus abdominis plane (TAP). Carney et al9 described a "posterior TAP" block, now known to be synonymous with QLB, that demonstrated contrast spread to the thoracic paravertebral space from T5-L1. Case reports have described analgesia in the corresponding sensory dermatomes after QLB4, and have demonstrated efficacy in patient undergoing THA. The QLB block has potential to cover lateral femoral cutaneous nerve, femoral nerve, obturator nerve and portions of lumbar plexus.

This study has been designed to investigate the efficacy of the quadratus lumborum block as a primary method of providing post-operative analgesia in patients undergoing THA. Previous trials have demonstrated the effectiveness of the block for abdominal and pelvic surgeries, and case reports have shown its applicability in hip arthroplasty. In this randomized controlled study we aim to compare QLB (intervention) with control (no intervention) group in patients undergoing THA with regard to the VAS pain scores (at PACU arrival \& discharge12, 24 \& 36 hours), duration of analgesia, time to first opioid medication, physical therapy evaluations, time to discharge, and surgeon and patient satisfaction scores.

Arms: arm 1: * Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia. arm 2: * Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Interventions: intervention 1: Quadratus Lumborum Block (QLB) intervention 2: Standard of Care
Intervention descriptions: intervention 1: Under ultrasound guidance, the needle will be advanced to the posterior border of the quadratus lumborum muscle. After negative aspiration, a bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots, ensuring proper placement of needle tip and appropriate spread of local anesthetic. intervention 2: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.

Protocol documents:
Prot_SAP_000.pdf: 




3. Protocol Personnel 
Including the PI, list all key personnel (each individual involved in the design and conduct of this protocol). See the Key Personnel Flowchart. 
 
Complete the UAB (3.a.) and non-UAB (3.b) tables, as applicable. Use the checkboxes to show each individual’s role, whether the individual has 
financial interests as defined by the UAB CIRB, and briefly describe the individual’s protocol responsibilities and qualifications to perform those 
responsibilities. Insert additional rows as needed. 
 
FDA: For studies involving investigational drugs, list all investigators who will be listed on FDA Form 1572 and include a copy of the 1572. Send 
the IRB a copy of Form 1572 any time you update the form with the FDA. 
 
a. UAB Personnel (includes UAB affiliates and Children’s of Alabama personnel) 
Name, Degree, and Dept. 
Blazer 
ID 
Role 
Financial Interest?* 
Protocol Responsibilities and 
Qualifications (indicate if 
this person obtains consent) 
Name: Promil Kukreja 
Degree: M.D., Ph.D. 
Department: 
Anesthesiology 
pkukreja 
Principal Investigator 
☒No 
☐Yes 
Oversees all aspects of project, 
obtains consent 
Name: Elie Ghanem 
Degree: MD 
Department: Orthopedic 
Surgery 
eghanem 
☒Sub-Investigator 
☐Other 
☒No 
☐Yes 
Maintains open line of 
communication between 
surgeons and anesthesiologists; 
monitors for adverse effects 
Name: Lisa MacBeth 
Degree: MD 
Department: 
Anesthesiology 
ldspeake 
☒Sub-Investigator 
☐Other 
☒No 
☐Yes 
Helps with recruiting, 
monitoring for adverse 
outcomes, data analysis 
Name: Joel Feinstein 
Degree: MD 
Department: 
Anesthesiology 
joelfein 
☒Sub-Investigator 
☐Other 
☒No 
☐Yes 
Helps with recruiting, supervises 
block placement 
Name: Prentiss Lawson 
Degree: MD 
Department: 
Anesthesiology 
pjlawson 
☒Sub-Investigator 
☐Other 
☒No 
☐Yes 
Helps with recruiting, supervises 
block placement 
Name: Dan Johns 
Degree: MD 
Department: 
Anesthesiology 
danjohns 
☒Sub-Investigator 
☐Other 
☒No 
☐Yes 
Data analysis 
b. Non-UAB Personnel Relying on UAB IRB - If you are requesting that the UAB IRB serve as the IRB of record for anyone not affiliated with 
UAB, list these individuals below. 
Name and Degree 
From Institution with or without own IRB? 
 
Financial Interest?* 
Protocol Responsibilities and 
Qualifications (indicate if this 
person obtains consent) 
Name:       
Degree:       
Institution:       
Email:       
☐Has own IRB but requests that UAB IRB serve 
as IRB of record?-OR- 
 
☐Does not have own IRB and needs to rely on 
UAB IRB. 
☐No 
☐Yes 
      
*Financial Interest – for each individual listed above, answer Yes or No as to whether the individual or an immediate family member has any of 
the following: 
• 
An ownership interest, stock options, or other equity interest related to the investigator’s institutional responsibilities of any value. 
• 
Compensation greater than $5,000 in the previous two years when aggregated for the immediate family 
• 
Proprietary interest including, but not limited to, a patent, trademark, copyright, or licensing agreement. 
• 
Board of executive relationship, regardless of compensation. 
• 
Any other Financial Interest as defined by the UAB CIRB. 
 
UAB Personnel: If the individual or his/her spouse or dependent child has a Financial Interest, a disclosure has to be made to the UAB CIRB. A 
completed CIRB evaluation has to be available before the IRB can complete its review. 
 
Non-UAB Personnel: If the individual has a Financial Interest, include a copy of the report from his/her own institution’s conflict of interest 
review with this submission to the UAB IRB. 
 
c. Do the investigators listed above include any students using this research for their thesis or dissertation? 
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☒ No, continue with Item 3.d. 
☐ Yes, complete the following 
Student Name 
Thesis/Dissertation Title 
      
      
 
d. Is the principal investigator a student, fellow, or resident? 
☐Yes ☒No 
If Yes, complete items below and obtain signature of faculty advisor or supervisor: 
 
 
e. Describe the principal investigator's activities related to this protocol and provisions made by the PI to 
devote sufficient time to conduct the protocol: As an attending anesthesiologist, the PI is able to 
devote sufficient time to conduct and provide oversight for this protocol.         
 
f. Is medical supervision required for this research? 
☒Yes ☐No 
If Yes, who will provide the medical supervision? 
☒ PI will provide -OR- 
☐ Other: 
Name:       Telephone:       
If other than PI, obtain signature of person providing medical supervision: 
Signature  
 
 
 
 
 
 
 
 
g. Describe your process for ensuring all key personnel are adequately informed about the protocol and 
their research-related duties and functions: All personnel who are involved in the design or conduct 
of this research study will have successfully completed and maintained UAB IRB required human 
subjects research training, which includes the importance of measures to protect patient 
confidentiality 
 
 
4. Funding 
Is this protocol funded? 
☐Yes ☒No 
 
If No, specify that costs of the protocol will be covered by funds from the UAB department or other source 
named: Anesthesiology 
 
If Yes, attach one copy of completed application or request for funding sent to sponsor, and complete a-d. 
a. Title of Grant, Contract, or Agreement:       
 
b. UAB PI of Grant, Contract, or Agreement:       
 
c. Office of Sponsored Programs (OSP) Assigned Number:       
(If not yet available, enter “Pending” and provide upon receipt from OSP.) 
 
d. Sponsor, Funding Route: 
(Check and describe all that apply) 
(If subaward, list both the funding source and the institution receiving the direct award) 
☐ Gov’t Agency or Agencies—Agency name(s):       
☐ Department of Defense (DoD): Identify DoD component:       
☐ Department of Energy (DOE) 
☐ Department of Justice (DOJ) 
☐ Department of Education 
Supervisor's Name:       
Degree(s) / Job Title:       
Additional Qualifications 
pertinent to the protocol: 
      
Telephone:       
E-Mail:       
Signature:  
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☐ NIH Cooperative Group Trial - Group name:       
☐ Private Nonprofit (e.g., Foundation) - Name:       
☐ Industry, investigator-initiated - Name:       
Describe the funding arrangement:       
NOTE:  The UAB IRB typically only reviews industry-sponsored protocols that are investigator 
initiated or when the protocol qualifies for expedited review or involves gene therapy. 
☐ UAB Departmental/Division Funds—Specify:       
 
5. Locations Involved 
a. Indicate all performance sites that will provide space, services, or facilities for the conduct of this 
protocol. 
☒ UAB Hospital 
☒ UAB Hospital - Highlands 
☐ The Kirklin Clinic of UAB Hospital 
☐ The Kirklin Clinic at Acton Road 
☐ UAB Callahan Eye Hospital 
☐ UAB Clinical Research Unit 
☐ Children's of Alabama 
☐ Birmingham Veterans Affairs Medical Center 
☐ Jefferson County Department of Health 
☐ Other (i.e., any performance site not listed above, including those covered by subawards related to 
this protocol) - Describe:  
NOTE:  Documentation of IRB approvals from sites receiving subawards must be received by the 
UAB OIRB before funding will be released for that subaward. 
 
b. Describe the space, service, or facilities available for the conduct of the research in the performance 
sites listed in Item 5.a (For research on UAB campus, include building names): The patients will be 
recruited and consented in their private rooms in the preoperative area of UAB Highlands. After 
enrollment and randomization, they will move to the block area that is well-equipped for 
placement of regional anesthesia techniques. 
 
c. Is this protocol a clinical trial requiring clinical services at one of the performance sites listed in Item 5.a 
above? 
☒Yes ☐No 
If Yes, will any of the services be billed to either participants/their insurance or to the study account 
through the Hospital Billing Office (PFS) or the HSF Billing Office (MSO)? 
☐Yes ☒No 
 
If Yes, submit a Full Fiscal Approval Process (FAP)-designated unit submission to s complete a FAP 
submission and send to fap@uab.edu. For more on the UAB FAP requirements, go to FAP - SiteMinder 
Processes. 
 
d. Is this a field study? 
☐Yes ☒No 
If Yes, describe the community and include information about how the community will be involved in 
the design, implementation and analysis of the research. This would include focus groups, training local 
facilitators/community health advisors:       
 
e. Has this protocol been rejected or disapproved by another review board (another IRB, similar review 
board, or departmental review committee(s)) that authorizes the use of its patient populations? 
 
☐Yes ☒No 
If Yes, provide name(s) of the review board(s) and reason(s) not approved:       
Attach copies of the disapprovals. 
NOTE:  If this protocol is subsequently rejected or disapproved by another review board, promptly notify 
UAB IRB. 
 
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f. Will the protocol be conducted at or recruit participants from the Birmingham Veterans Affairs Medical 
Center (BVAMC)? 
☐Yes ☒No 
If Yes, describe the involvement of the BVAMC:       
Attach the VA IRB approval and VA IRB-stamped consent form(s), if applicable. 
NOTE:  See the BVAMC section of the IRB Guidebook for more information. 
 
g. Will the protocol be conducted at or recruit participants from the Jefferson County Department of 
Health (JCDH)? 
☐Yes ☒No 
If Yes, describe the involvement of the JCDH and list the JCDH clinics being used:       
Attach the JCDH Research Review Panel approval, if applicable. 
NOTE:  Human subjects research conducted at certain JCDH clinics requires review by the JCDH 
Research Review Panel. See the JCDH section of the IRB Guidebook for more information. 
 
6. Clinical Trial 
Does this protocol meet the following definition of a clinical trial? 
☒Yes ☐No 
*A research study in which one or more human subjects are prospectively assigned to one or more 
interventions (which may include placebo or other control) to evaluate the effects of those interventions on 
health-related biomedical or behavioral outcomes. For more information, see the full definition of clinical 
trial here. 
If Yes, you will need to fulfill the following requirements (regardless of funding): 
 
a. All key personnel must complete the Good Clinical Practices (GCP) training. For information on this 
requirement, visit the IRB website here. 
 
b. This protocol must be registered on ClinicalTrials.gov. Provide the National Clinical Trial (NCT) identifier 
number: NCT 03408483 
If you have any questions regarding registering a study on ClinicalTrials.gov, email the UAB Center for 
Clinical and Translational Science at ccts@uab.edu. 
 
7. Multi-Site Studies 
a. Is this a multi-site study with the UAB investigator as the lead investigator? 
☐Yes ☒No 
 
b. Is this a multi-site study with UAB as a coordinating site? 
☐Yes ☒No 
 
c. If Yes to a or b, describe the management of information obtained in multi-site research that might be 
relevant to the protection of participants. Include, at a minimum, how the following items are 
managed: 
o IRB approvals from other sites 
o Unanticipated problems involving risks to participants or others. (For example, if there is an 
unanticipated problem involving risks to participants or others, which site is responsible for 
reporting it?) 
o Interim results 
o Protocol modifications 
      
 
8. Drugs 
Will any drugs or supplements be used or studied in this protocol? 
☒Yes ☐No 
If Yes, attach the completed Drug Review Sheet. 
 
9. Devices 
a. Will any devices be studied in this protocol? 
☐Yes ☒No 
 
b. Will any not FDA-approved devices be used or studied in this protocol? 
☐Yes ☒No 
If Yes to a or b, attach the completed Device Review Sheet. 
 
10. Special Approvals 
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a. Does this protocol involve the use of radioisotopes? 
☐Yes ☒No 
If Yes, attach documentation of approval from the Radiation Safety Division. 
 
b. Does this protocol include patients with contagious infections (e.g., mumps, measles, chickenpox, TB, 
meningitis)? 
☐Yes ☒No 
If Yes, attach documentation of approval from the Infection Control Committee of the appropriate 
facilities. 
 
c. Does this protocol involve obtaining remnant biopsy or surgical material from the Department of 
Pathology or any other source? 
☐Yes ☒No 
If Yes, attach documentation of approval from the entity or individual providing the materials (e.g., 
the UAB Division of Anatomic Pathology Release of Pathologic Materials). 
 
d. Does this protocol require obtaining any remnant clinical laboratory specimens, body fluids, or 
microbiological isolates from the Department of Pathology or any other source? 
☐Yes ☒No 
If Yes, attach documentation of approval from the entity or individual providing the materials (e.g., 
the UAB Division of Laboratory Medicine Release of Pathologic Materials). 
 
e. Does this protocol use stored (existing) specimens from a repository? 
☐Yes ☒No 
If Yes, attach documentation of approval for use of specimens, and describe how existing specimens 
are labeled:       
 
11. Use of Specimens 
Does this protocol involve the collection of specimens? 
☐Yes ☒No 
If Yes, complete 11.a-11.h. 
If No, skip to Item 12. 
a. How will specimens be obtained, processed, distributed, and stored?       
 
b. How will specimens be labeled (e.g., unique identifier, medical record number, Social Security number, 
name, date of birth)?       
 
c. How will clinical data associated with the specimens be collected and stored?       
 
d. What participant-identifying information will be collected and linked to the specimens?       
 
e. What steps will be taken to maximize the confidentiality of linked identifiers? For example, procedures 
could include using a password-protected computer database to link identifiers, with limited personnel 
knowledgeable of the password, or coded identifiers released without the ability to link to clinical data 
(also called “stripped” or “anonymized” specimens).       
 
f. Is genetic testing planned as part of this protocol? 
☐Yes ☐No 
If Yes, describe the planned genetic testing here.       
 
g. Will specimens be stored for future use? 
☐Yes ☐No 
If Yes, indicate whether they will be used for the disease under study in this protocol or research on 
other diseases.       
 
h. Will specimens be shared with other investigators in the future? 
☐Yes ☐No 
If Yes, answer i. and ii. 
i. What identifiers, clinical information and demographic information will be shared; or will the 
specimens be stripped of identifiers (i.e., anonymized)?       
ii. Outline your procedure for assuring IRB approval for release and use prior to release of specimens. 
      
NOTE:  Investigators who receive and/or use these specimens must document approval from the 
appropriate IRB(s) before the specimens may be released. 
 
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12. Gene Therapy 
Does this protocol involve gene therapy or administering recombinant materials to humans? 
☐Yes ☒No 
If Yes, submit the Gene Therapy Project Review Panel Report -OR- the Protocol Oversight Review Form For 
Clinical Vaccine Trials, as applicable. 
 
13. HIPAA Privacy and Security 
Will the PI or others obtain, review, or make other use of participants' “protected health information” (i.e., 
information, whether oral or recorded in any form or medium that (a) is created or received by a health 
care provider and (b) relates to past, present, or future physical or mental health or condition of an 
individual; or provision of health care; or payment for provision of heath care)? 
☒Yes ☐No 
If Yes, complete Items 13.a-13.f. 
If No, skip to 14. 
 
a. Will the data/information be stored or managed electronically (on a computer)? 
 
☒Yes ☐No 
 
b. Is the principal investigator requesting that the UAB IRB waive patient HIPAA authorization from 
another institution or entity (e.g., insurance company, collaborating institution)? 
☐Yes ☒No 
If Yes, attach copies of the privacy notices from each institution/entity, and provide the name of each 
institution/entity:       
 
c. Indicate which of the entities would provide health information for this protocol, maintain health 
information as it was collected for this protocol, and/or store health information after it has been 
collected for this protocol. 
☒ UAB Hospital or UAB Hospital - Highlands 
☐ The Kirklin Clinic of UAB Hospital or Acton Road (and/or associated clinics) 
☐ UAB Callahan Eye Hospital 
☐ Children's of Alabama 
☐ Jefferson County Department of Health 
☐ School of Dentistry 
☐ School of Health Professions 
☐ School of Medicine 
☐ School of Nursing 
☐ School of Optometry 
☐ University of Alabama Health Services Foundation 
☐ UAB Health Centers 
☐ Viva Health 
☐ Ophthalmology Services Foundation 
☐ Valley Foundation 
☐ Medical West - UAB Health System Affiliate 
☐ None - If None, skip to Item 14. 
 
d. Indicate any information systems that will be the sources of information used for the protocol. 
☒ A system maintained centrally by UAB Health System (these include the following: HealthQuest for 
registration, billing, and patient administration; PowerInsight (clinical data warehouse); Cerner 
IMPACT for PowerNotes for meds, Lab, Radiology, UED, Surgery 
 
NOTE:  If a researcher needs information in a specified format or a specified time, the researcher 
must confirm with the unit who can supply the information/service that the request can be met 
before writing the information/service into the research protocol. In addition, the researcher must 
be aware that these services may have a cost attached that should be considered in the research 
budget. 
 
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To request access to clinical systems for research purposes, 
visit https://www.oneuabmedicine.org/web/hsis/technical-support, click “Accounts Request” and 
complete the form indicating access for research purposed. 
☐ Another system on a UAB server - Describe:       
 
e. Indicate which of the listed identifiers will be accessed, associated and/or linked with the protected 
health information (PHI) used for this protocol. 
☒ Names 
☐ Geographic subdivisions smaller than a state 
☒ Elements of dates (except year) related to an individual 
☒ Telephone numbers 
☐ Fax numbers 
☐ Email addresses 
☐ Social security numbers 
☒ Medical record numbers 
☐ Health plan beneficiary numbers 
☐ Account numbers 
☐ Certificate/license numbers 
☐ Vehicle identifiers and serial numbers 
☐ Device identifiers and serial numbers 
☐ Biometric identifiers 
☐ Web universal resource locators (URLs) 
☐ Internet protocol address numbers 
☐ Full-face photographic images 
☐ Any other unique identifying number - Describe:       
NOTE:  Codes are not identifying as long as the researcher cannot link the data to an individual 
☐ None - If None, skip to Item 14. 
 
f. Choose one plan to describe your use of the personal health information: 
☐ The data collected meet the specifications for a “limited data set” (LDS) 
-If the LDS will leave the covered entity or will be received from another covered entity you will 
need a Data Use Agreement 
 
☒ Research staff will obtain authorization from each participant to use the information 
-Include the HIPAA Authorization form, complete except for participant name and IRB protocol 
number, as the final page of the consent form 
 
☐ PI requests waiver of authorization to use the information 
-Attach Waiver of Authorization and Informed Consent form 
 
PROPOSED RESEARCH 
• The IRB will not accept grant applications and/or sponsor's protocols in lieu of the items as outlined below. 
• Do not separate responses from items. Instead, insert your response to each item below the item, keeping 
the information in the order of this form. 
 
14. Purpose - in nontechnical, lay language 
a. Summarize the purpose and objectives of this protocol in one short paragraph. 
 Peripheral nerve blocks for joint and extremity surgeries have long been proven to provide effective 
post-operative analgesia. Of these surgeries, total hip arthroplasty (THA) remains one of the most 
common orthopedic procedures in the United States with approximately 300,000 operations performed 
annually1. At our institution, post-operative analgesia in these patients is often provided through 
parenteral and oral opioid medications. Quadratus lumborum blocks (QLB) have been described and 
implemented for various surgical procedures including caesarean section2,3  and laparoscopic ovarian 
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surgery4.  Recently, there has been increasing interest in the effectiveness of pain control with the use of 
quadratus lumborum blocks after THA . Currently, case reports have established a precedent regarding 
the efficacy of the QLB for THA5, 6,10 in providing superior analgesia and decreasing verbal numerical 
pain scores, but randomized trials are still lacking. The goal of this study is to compare verbal numerical 
pain scores, post-operative pain medication (opioid) consumption, physical therapy scores, and patient 
satisfaction in patients that receive QLB versus no peripheral nerve blockade in patients undergoing 
THA. The results of this study have the potential to change the standard of care for patients undergoing 
THA.  
 
 
b. Describe how outcomes will be measured for this protocol. 
 The primary end points are as follows: 
1. Pain scores (numerical) will be obtained at immediate post op, 24 hours and 48 hours after surgery 
2. Pain medication (opioid) use intraoperatively, as well as at 24 hours and 48 hours postoperatively 
3. Physical therapist assessment of independence in mobility and transfers 
4. Distance ambulated at 24 hours and 48 hours after surgery. 
 
 
15. Background - in nontechnical, lay language 
Summarize in 2-3 paragraphs past experimental and/or clinical findings leading to the design of this 
protocol. Include any relevant past or current research by the PI. For drug and device studies, summarize the 
previous results (i.e., Phase I/II or III studies).  
Currently, regional anesthesia techniques for total hip arthroplasty are limited. Fascia iliaca blocks 
(nerve blocks between the muscles of the hips) have been employed to provide analgesia for hip surgeries 
with blockade of the femoral, lateral femoral cutaneous, and obturator nerves via injection of local 
anesthetic in the iliacus fascia. In addition, lumbar plexus blocks have also been employed for post-
operative analgesia, but the complexity of the block is high, and complications including epidural 
anesthesia are not infrequent. The quadratus lumborum block (QLB) is an abdominal truncal block in 
which local anesthetic is deposited into the thoracolumbar fascia (area between the muscle) or the 
quadratus lumborum muscle itself with the goal of providing analgesia to the ipsilateral T6 – L1 sensory 
dermatomes. It has already been demonstrated to provide effective post-operative analgesia for certain 
abdominal and pelvic surgeries7, but its use in total hip arthroplasty is limited to case reports.  
The block is accomplished by locating the quadratus lumborum muscle, using a ultrasound probe. 
Local anesthetic is then injected. Cadaveric studies8 have demonstrated dye spread to the lumbar nerve 
roots and nerves within the transversus abdominis plane (TAP). Carney et al9 described a “posterior 
TAP” block, now known to be synonymous with QLB, that demonstrated contrast spread to the thoracic 
paravertebral space from T5-L1. Case reports have described analgesia in the corresponding sensory 
dermatomes after QLB4, and have demonstrated efficacy in patient undergoing THA 5,6,10.   The QLB 
block has potential to cover lateral femoral cutaneous nerve, femoral nerve, obturator nerve and portions 
of lumbar plexus.  
This study has been designed to investigate the efficacy of the QLB in providing post-operative pain 
control patients undergoing THA. Previous trials have demonstrated the effectiveness of the block for 
abdominal and pelvic surgeries, and case reports have shown its applicability in hip arthroplasty.  In this 
randomized, controlled study we aim to compare QLB (block group) with control (control group) in 
patients undergoing THA with regard to verbal numeric pain scores (to be obtained when patient arrives 
to PACU & at discharge from PACU, then at 24 and 48 hours after surgery).  The duration of analgesia, 
time to first opioid medication, physical therapy evaluations, time to discharge, and patient satisfaction 
scores will also be obtained. 
 
 
 
 
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16. Participants (Screening and Selection) 
a. How many participants are to be enrolled at UAB (if other sites relying on UAB IRB, list the number for 
each site)? 100 
If multi-site study, total number at all sites/institutions: N/A 
 
b. Describe the characteristics of anticipated or planned participants (if multiple groups, repeat list for 
each group). 
Sex: M,F 
Race/Ethnicity: any 
Age: ≥18 years 
Health status: American Society of Anesthesiologist (ASA)  Physical Status Score 1, II, or III 
 
c. From what population(s) will the participants be derived? All patients scheduled for total hip 
arthroplasty are scheduled in the preoperative assessment clinic days to weeks prior to their 
surgery. Study participants will be derived from this population. 
 
 
Describe your ability to obtain access to the proposed population that will allow recruitment of the 
necessary number of participants: Before total hip arthroplasty, all patients report to the Highlands 
Preoperative assessment Clinic (HPAC) for standard of care preoperative assessment and 
examination and preoperative testing, tailored to patient comorbidities.  This is not a service that 
will be billed additionally for study participants, as it is standard of care for all total hip 
arthroplasty patients, regardless of participation in the study.  During this visit they will be given 
a “Patient Information Sheet,” describing the study. On the day of surgery, patients scheduled for 
surgery will be seen in the preoperative holding area and enrolled in the study if they choose and 
are appropriate candidates.  
 
 
d. Describe the inclusion/exclusion criteria:  
Inclusion Criteria: Patients undergoing total hip arthroplasty under spinal anesthesia. Adults, 18 
years of age or older. Patients classified by the American Society of Anesthesiology (ASA) class I, 
II, or III.  
 
Exclusion Criteria; Any patient not classified as an ASA I, II, or III. Those who are allergic or 
intolerable to local anesthetics. Patients with pre-existing neurologic or anatomic deficiency and 
lower extremity on the side of the surgical site, or patients with coexisting coagulopathy. Patients 
that are pharmacologically anticoagulated will be excluded if placement of peripheral nerve block 
would be contraindicated according to ASRA (American Society for Regional Anesthesia) 
guidelines or if spinal anesthesia would be contraindicated according to ASRA guidelines.  
 
 
 
e. If participants will comprise more than one group or stratification, describe each group (e.g., 
treatment/intervention, placebo, controls, sham treatment) and provide the number of participants 
anticipated in each group.  
Upon enrollment in the study, participants will be randomized 1:1 to either the investigational 
group (“Quadratus Lumborum Block” group) or the control group (“No Block” group). 
Participants will be randomized using a random number generator.  
 
 
f. Indicate which, if any, of the special populations listed below will be involved in the protocol. Include the 
Special Populations Review Form (SPRF) if indicated. 
☐ Pregnant Women: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
☐ Fetuses: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
☐ Neonates/Nonviable Neonates: SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
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☐ Prisoners: Attach SPRF—Prisoners 
☐ Minors (<18 years old): Attach SPRF—Minors 
☒ Employees or students at institution where research conducted 
☐ Persons who are temporarily decisionally impaired 
☐ Persons who are permanently decisionally impaired 
☐ Non-English Speakers 
For each box checked, describe why the group is included and the additional protections provided to 
protect the rights and welfare of these participants who are vulnerable to coercion: Employees and 
students are eligible to participate.  The suggested language has been included in the informed 
consent document to fully disclose that this project is separate from the expectations and their 
relationship with UAB as an employee or student.  
 
 
g. List any persons other than those directly involved in the protocol who will be at risk. If none, enter 
“None”: None 
 
h. Describe the recruitment process (e.g., medical record review, referrals, letter of invitation, existing 
patients) that will be used to seek potential participants (e.g., individuals, records, specimens). 
Research recruitment by non-treating physicians/staff may require completion of Partial Waiver of 
Authorization for Recruitment/Screening. Days to weeks prior to total hip arthroplasty, patients 
report to the Highlands Preoperative Assessment Clinic (HPAC) for standard of care preoperative 
evaluation and examination and preoperative testing, tailored to patient comorbidities. This is not 
a service that will be billed additionally for study participants, as it is standard of care for all total 
hip arthroplasty patients, regardless of participation in the study. During their HPAC visit, 
patients that may be eligible for the study will be given a “Patient Information Sheet,” describing 
the study. On the day of surgery, patients will be seen in the preoperative holding area and 
enrolled in the study if they choose. 
 
All surgeons who perform total hip arthroplasty have requested for their patients to have QLB, at 
the discretion of the anesthesiologist. 
 
 
i. If you will use recruitment materials (e.g., advertisements, flyers, letters) to reach potential participants, 
attach a copy of each item. If not, identify the source (e.g., IRB Protocol Number for approved 
databases) from which you will recruit participants. N/A 
 
j. Describe the screening process/procedures for potential participants.    
Study personnel will confirm eligibility requirements using a standardized eligibility checklist.  
This will be completed by the PI or another member of the research team prior to consenting and 
enrolling subjects in the study. This eligibility screening will occur in the preoperative holding 
area where each patient is in a private room. We have attached the Partial HIPAA Waiver for 
Recruitment and Screening. 
 
All surgeons who perform total hip arthroplasty have requested for their patients to have QLB, at 
the discretion of the anesthesiologist. 
 
 
 
17. Protocol Procedures, Methods, and Duration - in nontechnical, lay language 
 Describe the procedures for all aspects of your protocol. Tell us what you are doing.  
A. Participants in the study will be randomly assigned to either receive the pain block (“block 
group”) or not (“control group”).  The patient will be blinded and thus unaware of the group 
that they have been assigned.  The patients are receiving sedation, including fentanyl and 
midazolam, an amnestic, prior to ultrasound scanning and +/- block placement. The amnestic 
properties of sedation will serve as blinding for the procedure. In the postoperative survey, we 
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ask the patients which group they believe they were in, which will help assess the adequacy of 
the blinding. 
a. Block group:  Subjects that are in the block group will receive the pain block while they 
are in pre-operative holding. The block will be administered as follows: 
i. The patient will be placed on their side.  Standard of care noninvasive monitors 
will be used, and oxygen will be given by nasal cannula. Midazolam and fentanyl 
will be given to patient comfort.  Note: midazolam and fentanyl are provided to 
all patients who are receiving this surgery and is not part of this research 
project.  The timing of the delivery of this medication may differ than standard 
of care, but the doses and indications are the same. Skin will be prepped and 
draped as per standard of care.    
ii. Using ultrasound guidance, we will locate the appropriate space for the block.  
We will first inject numbing medication called lidocaine under the patient’s skin 
(1-2 mL of 1% lidocaine; 10-20 mg).  Then, we will inject another numbing 
medication called bupivacaine (30 mL of 0.25% bupivacaine with 1:400,000 
epinephrine; 75 mg bupivacaine and 75 mcg epinephrine) between muscles using 
a syringe and needle. 
iii. After the block is placed, patients will have their surgery performed. 
b. Control group:  Patients randomized to the control group will be treated in the same 
manner (as described in section “i” above) as those randomized to the block group.  The 
ultrasound probe will be used to identify the quadratus lumborum muscle, similar to 
patients in the block group. However, no local anesthetic will be injected. 
B.  Postoperative data will be collected for both groups by a blinded study team member listed on 
this protocol.   
a.  Post-operative data that will be collected is listed in the attached Case Report Form.   
b.  Information obtained from the patient will be collected using the attached Patient 
Interview Script.  
c. Patient will be followed up until nerve block resolves. 
d. The hours from block placement until hospital discharge will be calculated. 
 
 
b. What is the probable length of time required for the entire protocol (i.e., recruitment through data 
analysis to study closure)? One year. 
 
 
c. What is the total amount of time each participant will be involved? Each participant will be 
involved in the study for approximately 48 hours.  Each procedure time period is listed below.  
 
 
d. If different phases are involved, what is the duration of each phase in which the participants will be 
involved? If no phases are involved, enter “None.” None 
 
e. List the procedures, the length of time the procedure takes, the total # of times the procedure is 
performed, and indicate whether each is performed solely for research or would already be performed 
for treatment or diagnostic purposes (routine care) for the population. 
-Insert additional table rows as needed. 
-If procedure is sometimes research and sometimes routine care, include on separate lines with number 
of times as each. 
 
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Procedure 
Length of Time 
Required of 
Participants 
Frequency of 
Repetition 
Research (Res) –
OR- Routine Care  
Pre-surgical Evaluation on the 
day of surgery 
 
 
Randomization on day of surgery 
 
 
Placement of block 
 
 
Post Anesthesia Care Unit 
(PACU) assessment 
 
 
First postoperative assessment 
survey (approximately 24 hours 
after surgery) 
 
 
Second postoperative assessment 
survey (approximately 48 hours 
after surgery) 
30 minutes 
 
 
 
5 minutes 
 
 
Approximately 30 min. 
 
 
10 minutes 
 
 
 
10 minutes 
 
 
 
 
10 minutes 
 
once 
 
 
 
Once 
 
 
Once 
 
 
Once 
 
 
 
Once 
 
 
 
 
Once 
 
Res 
Routine 
 
 
 
Res 
Routine 
 
 
Res 
Routine 
 
 
Res 
Routine 
 
 
 
Res 
Routine 
 
 
 
 
Res 
Routine 
 
 
f. Will an interview script or questionnaire be used? 
☒Yes ☐No 
If Yes, attach a copy. 
 
g. Will participants incur any costs as a result of their participation? 
☐Yes ☒No 
If Yes, describe the reason for and amount of each foreseeable cost.       
 
h. Will participants be compensated? 
☐Yes ☒No 
If Yes, complete i-v. 
i. Type: (e.g., cash, check, gift card, merchandise):       
ii. Amount or Value:       
iii. Method (e.g., mail, at visit):       
iv. Timing of Payments: (e.g., every visit, each month):       
v. Maximum Amount of Compensation per Participant:       
 
18. Benefits 
Describe the potential benefits of the research. Effective post-operative pain control with regional 
analgesia can reduce the amount of opioid medications needed perioperatively and therefore, may 
help participation in physiotherapy, leading to more effective rehabilitation and shorter times to 
discharge from the hospital. Additionally, greater perioperative pain control can enhance 
patients’ perioperative satisfaction. 
 
 
19. Risks - in nontechnical, lay language 
a. List the known risks for participants as a result of participation in the research. This should not include 
the minimal risk of loss of confidentiality. However, it should include any physical, psychological, social, 
economic, and/or legal risks. If there is a greater than minimal risk of loss of confidentiality describe 
why this is so. Do not list risks associated with the standard-of-care procedures. 
NOTE:  Risks included here should be included in the consent form or information sheet, as applicable. 
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Assessment of Level of Risk: Minimal risk. Participants in this study have the risk associated with 
peripheral nerve block including pain and discomfort from the procedure, excessive bleeding, 
infection, nerve damage and failed analgesia.  THA is done at this institution currently either with 
or without QLB.  The study would scientifically compare the two existing methods of 
perioperative pain control (with or without QLB) to each other. 
 
Risks Associated with 0.25 % Bupivacaine with 1:400,000 epinephrine 
Reactions to bupivacaine are similar to those associated with other amide-type local anesthetics. This risk of 
reactions is mitigated when injected into local tissues under ultrasound guidance to assure there is no 
intravascular injection. Dilute epinephrine is commonly added to bupivacaine to constrict nearby blood vessels, 
thereby decreasing vascular uptake of the medication and prolonging its duration of effect in local tissues. 
Bupivacaine with epinephrine may be safely used for infiltration during regional anesthesia in amounts up to 
225 mg, with total daily doses not to exceed 400 mg. Common (occurring in ≥5% uses) reported adverse events 
derived from clinical studies conducted in the U.S. and other countries include low blood pressure (37%), 
nausea (24.8%), vomiting (11.6%), slow heart rate (9.3%), fever (9.2%), pain (8%) postoperative complications 
(7.1%), low blood count (6.1%), numbness or weakness in limbs (5.6%), headache (5.1%), pruritus (5.1%), and 
back pain (5%). A major cause of complications resulting from this group of drugs may be associated with 
excessive plasma levels, which may be due to over-dosage, unintentional intravascular injection or slow 
metabolic degradation. In the case of excessive plasma levels, abnormal heart rhythms, cessation of heart beat, 
loss of consciousness, and/or seizures could occur.   
 
We will be using 0.25% of bupivacaine with 1:400,000 epinephrine (75 mg bupivacaine with 75 mcg 
epinephrine), which is very common in our practice of regional anesthesia. We have experienced minimal 
adverse effects with 0.25% bupivacaine with epinephrine used in the amount suggested in our study.  
 
 
Risks Associated with Lidocaine 
Lidocaine is an amino-amide local anesthetic that is commonly used for anesthetization of the skin by 
injecting 3 mL of 1% lidocaine into the subcutaneous tissue. The toxic dose of lidocaine is 3 mg/kg. In an 80 kg 
(176 lbs) adult, this is equivalent to 240 mg, or 24 mL of 1% lidocaine. The adverse effects of lidocaine are 
similar to bupivacaine and include: central nervous system reactions including restlessness, anxiety, blurred 
vision, tremors, convulsions; cardiovascular system reactions including myocardial depression, decreased 
cardiac output, heart block, hypotension, bradycardia, arrhythmias, and cardiac arrest; allergic reactions include 
uticaria, pruritus, angioedema, tachycardia, and diaphoresis. The risk is exacerbated by high volume, high 
concentration, or intravascular injections. Clinically, 1% lidocaine has an excellent safety profile when 
administered by appropriately educated and trained personnel. 
 
 
 
 
b. Estimate the frequency, severity, and reversibility of each risk listed.  
Quadratus lumborum blocks techniques being evaluated use the most current methods available 
to reduce the risks of complications.  Major complications such as permanent nerve injury are 
rare.  There is limited data on the actual rate of permanent nerve injury due to the rarity of 
occurrence. 
 
 
 
c. Is this a therapeutic study or intervention? 
☒Yes ☐No 
If Yes, complete i.-iii. 
i. Describe the standard of care in the setting where the research will be conducted: This will be a 
comparison of efficacy of two different approaches of perioperative pain control for total hip 
arthroplasty. The current standard of care at our institution does not involve regional analgesia 
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for postoperative pain control, however quadratus lumborum blocks have shown in case reports 
to provide analgesia for hip arthroplasty.    
ii. Describe any other alternative treatments or interventions: None 
iii. Describe any withholding of, delay in, or washout period for standard of care or alternative 
treatment that participants may be currently using: None 
 
d. Do you foresee that participants might need additional medical or psychological resources as a result of 
the research procedures/interventions? 
☐Yes ☒No 
If Yes, describe the provisions that have been made to make these resources available.       
 
e. Do the benefits or knowledge to be gained outweigh the risks to participants? 
 
☒Yes ☐No 
If No, provide justification for performing the research:       
 
20. Precautions/Minimization of Risks 
a. Describe precautions that will be taken to avoid risks and the means for monitoring to detect risks. 
We will use the standard precautions for placement of regional blocks which include sterile 
technique and ultrasound-guided placement.  Patients will be monitored during regional block 
placement with pulse oximetry, EKG, non-invasive blood pressure and capnograph monitors. 
Regional block will be performed under routine sterile conditions. 
 
A data and safety monitoring plan will be implemented by Drs. Kukreja and MacBeth to ensure 
that there are no changes in the risk/benefit ratio during the course of the study and that 
confidentiality of research data is maintained. This will be achieved by close following of study 
participants to screen for adverse events and interim results analysis during data collection phase. 
Investigators and study personnel will meet either electronically or in person, monthly (more often 
if needed) during active participant enrollment to discuss the study (e.g., study goals and 
modifications of those goals; subject recruitment and completion; progress in data coding and 
analysis; documentation, identification of adverse events or research subject complaints; 
violations of confidentiality) and address any issues or concerns at that time.  A DSMB committee 
will review outcomes and any adverse events as they occur or every six months (if no adverse or 
reportable events).  The DSMB consists of Dr. Dale Parks, Dr. Ayesha Bryant, Dr. Timothy Ness, 
Dr. Mark Powell. 
 
 
If the protocol involves drugs or devices skip Items 20.b. and 20.c. and go to Item 21. Instead include this 
information in the Drug Review Sheet or Device Review Sheet, as applicable. 
 
 
b. If hazards occur to an individual participant, describe (i) the criteria that will be used to decide 
whether that participant should be removed from the protocol; (ii) the procedure for removing such 
participants when necessary to protect their rights and welfare; and (iii) any special procedures, 
precautions, or follow-up that will be used to ensure the safety of other currently enrolled participants. 
If the patient meets the inclusion criteria, the block will be administered.   Any negative event will 
be evaluated and treated as per standard of care.  Each patient will have immediate follow-up 
evaluation performed by the PI or co-investigators to look for safety concerns. 
 
 
c. If hazards occur that might make the risks of participation outweigh the benefits for all participants, 
describe (i) the criteria that will be used to stop or end the entire protocol and (ii) any special 
procedures, precautions, or follow-up that will be used to ensure the safety of currently enrolled 
participants. 
 Quadratus lumborum blocks are described for perioperative analgesia for abdominal procedures 
and hip arthroplasty.  We do not anticipate additional risks for the patients who choose to 
participate in the study, as compared to other patients who undergo truncal blocks.  
 
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A data and safety monitoring plan will be implemented by Drs. Kukreja and MacBeth to ensure 
that there are no changes in the risk/benefit ratio during the course of the study and that 
confidentiality of research data is maintained. This will be achieved by close following of study 
participants to screen for adverse events and interim results analysis during data collection phase. 
Investigators and study personnel as well as the DSMB (consisting of clinicians and scientists:  Dr. 
Dale Parks, Dr. Ayesha Bryant, Dr. Timothy Ness, Dr. Mark Powell) will meet either 
electronically or in person, to evaluate any adverse or reportable event every six months during 
active participant enrollment. 
 
 
21. Informed Consent 
a. Do you plan to obtain informed consent for this protocol? 
☒Yes ☐No 
If Yes, complete the items below. 
If No, complete and include the Waiver of Informed Consent or Waiver of Authorization and Informed 
Consent, as applicable. 
 
b. Do you plan to document informed consent (obtain signatures) for this protocol? 
☒Yes ☐No 
If Yes, complete the items below. 
If No, complete the items below and include the Waiver of Informed Consent Documentation. 
 
c. How will consent be obtained? The interviewing investigator will confirm eligibility and absence of 
any exclusionary criteria.  Details of the study (including risks) will be explained to prospective 
participant to their satisfaction and consent forms will then be signed. 
 
Informed consent will be obtained electronically using REDCap, a HIPAA compliant application.  
The UAB IRB has approved the use of REDCap for e-consents and HIPAA Authorization in other 
studies in the Department of Anesthesiology.  The electronic Informed Consent (e-consent or eIC) 
is similar to the traditional paper-based Informed Consent in that it provides the potential subject 
with sufficient information about the research project to allow for an informed decision about the 
subject’s voluntary participation in the study.  The workflow for the consenting process will be the 
same as for the traditional paper consent/authorization.  The Principal Investigator or study staff 
trained in providing Informed Consent will be present during the entire consenting process.  The 
study staff will verbally present the study as with the paper form and then log into REDCap using 
unique credentials and a secure password.  The subject will be presented with a touch screen 
enabled tablet (or paper copy if the subject requests).  The subject will be allowed to read the e-
consent and then ask the study personnel questions about the material as well as address any 
follow-up questions.   Once the subject is fully satisfied that they have an understanding of the 
information being presented in the Informed Consent, the patient (or legally authorized 
representative) will use an electronic pen to provide a “wet signature” verifying their consent to 
participate in the study (signed in the presence of study personnel).  The computer will provide 
time/date stamps as the time of the signature.  The prospective subject will also digitally sign the 
HIPAA Authorization.  In the case of the involvement of a legally authorized representative, the 
representative will digitally sign as well as type the printed name and their relationship to the 
participant using the attached keyboard. All versions of the IRB approved versions of the 
Informed Consent will be archived and easily retrievable.  There some patients who may not feel 
comfortable with electronic systems, or have poor eyesight or impaired motor skills, so the patient 
will always have the option to using paper-based informed consents.  In this case, the signed paper 
consent form will be scanned and entered into REDCap as an attached document.  If requested, 
study personnel will provide assistance in the navigation of the e-consent.   
 
d. Who will conduct the consent interview? The Principal Investigator or study staff trained in 
providing Informed Consent will consent the patient and be present during the entire consenting 
process.  All study staff will be fully trained and approved by the IRB.  
 
 
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e. Who are the persons who will provide consent, permission, and/or assent? The patient or their Legally 
Authorized Representative (LAR) 
 
f. What steps will be taken to minimize the possibility of coercion or undue influence? Participation is 
voluntary and the potential participant will have every opportunity to ask any questions and raise 
any concerns and have those issues addressed to their satisfaction prior to obtaining and 
documenting consent. 
 
g. What language will the prospective participant and the legally authorized representative understand? 
English 
 
 
h. What language will be used to obtain consent? English 
 
 
i. If any potential participants will be, or will have been, in a stressful, painful, or drugged condition before 
or during the consent process, describe the precautions proposed to overcome the effect of the 
condition on the consent process. If not, enter “None.” None 
 
j. If any protocol-specific instruments will be used in the consenting process, such as supplemental  
handouts, videos, or websites,  describe these here and provide a copy of each. If not, enter “None.” 
None 
 
k. How long will participants have between the time they are told about the protocol and the time they 
must decide whether to enroll? If not 24 hours or more, describe the proposed time interval and why 
the 24-hour minimum is neither feasible nor practical.  
The consent process will begin during the potential participant’s pre-operative visits to UAB.  
Participants may not have more than 24 hours after learning of the study before documenting 
their consent to participate, but they will have additional days following screening and 
documentation of consent before implementation of any study specific procedures.  
 
 
22. Procedures to Protect Privacy 
Describe how you will protect the privacy interest of the participants. Include how you will make sure 
others cannot overhear your conversation with potential participants and that individuals will not be 
publicly identified or embarrassed. Privacy will be ensured at all times.  Conversations with 
potential participants will be conducted privately, usually in an exam room with a closed door to 
prevent others from overhearing the conversation.  Individuals will not be publicly identified or 
embarrassed. 
 
 
23. Procedures to Maintain Confidentiality 
a. Describe how you will store research data to maintain confidentiality (both paper records and 
electronic data), including how access is limited. If data will be stored electronically anywhere other 
than a server maintained centrally by UAB, identify the department and all computer systems used to 
store protocol-related data. Participant data will be stored on a password-protected server 
maintained for human subject’s research purposes by the UAB Department of Anesthesiology. 
Access to this particular system is restricted to only approved members of the research team. The 
list of patients participating in the study, including their medical record numbers and dates of 
surgery, will be kept separately in a folder with access restricted to staff approved to access 
patient data.  Access to the data will be terminated after final data analysis. Any original paper 
records may be scanned and stored on the above mentioned departmental server and then 
shredded after they have been transferred to the password-protected computer system.  Signed 
Informed Consents will be retained for at least 3 years after closure of this study.   
 
 
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b. Will any data from this protocol be given to any person, including the subject, or any group, including 
coordinating centers and sponsors? 
☒Yes ☐No 
If Yes, complete i-iii. 
i. Who will receive the data? Information will be shared with the UAB Anesthesiology faculty and 
residents, and other entities within the UAB Health System for quality improvement. 
Information may be presented at scientific meetings, conferences or may be published. 
 
ii. What data will be shared? Findings from study. Information regarding participant demographics will 
only be presented in aggregate form – age, sex, race, educational level, ASA (American 
Society of Anesthesiologists) status. . Additionally, results obtained from the study may be 
shared, including VAS scores for pain and need for rescue pain medication.   
 
iii. How will the data be identified, coded, etc.? Information will be de-identified and will be presented in 
aggregate form.  None of the 18 HIPAA Identifiers will be disclosed 
 
 
 
24. Genomic Data Sharing (GDS) 
Researchers who collect genomic data as part of a NIH grant funded after January 25, 2008 may be 
required to submit those data to a NIH database for broad scientific sharing. See Genomic Data Sharing in 
the IRB Guidebook for more information. 
 
a. Does this protocol involve the proposed submission of genetic data into genomic repositories created to 
share genetic information for research purposes? 
☐Yes ☒No 
 
b. Will UAB be uploading the final genomic data to the central repository (e.g., dbGaP)? 
☐Yes ☒No 
If Yes to both a and b, submit a Detailed Data Sharing Plan to the IRB for review. This plan should 
include any known data use limitations and indicate whether aggregate-level data are appropriate for 
general research use. For guidance see the NIH Genomic Data Sharing Policy. 
 
c. Submit a copy of the NIH Institutional Certification Form. 
To determine which certification form to include, answer i-ii. 
i. Was this protocol funded prior to January 25, 2015? 
☐Yes ☒No 
• If yes, and consent will be obtained, submit the Extramural Institutional Certification - Before 
January 25 - With Consent. 
• If yes, and consent will not be obtained, submit the Extramural Institutional Certification - 
Before January 25 - Without Consent. 
ii. Was this protocol funded after January 25, 2015? 
☐Yes ☒No 
• If yes, submit the Extramural Institutional Certification - After January 25. 
 
25. Additional Information 
In the space below, provide any additional information that you believe may help the IRB review the 
proposed research, or enter “None.” None 
 
References:  
1. Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 
and over: United States, 2000–2010. NCHS data brief, no 186. Hyattsville, MD: National Center for 
Health Statistics. 2015. 
2. Blanco, R., Ansari, T., & Girgis, E. (2015). Quadratus lumborum block for postoperative pain after 
caesarean section. European Journal of Anaesthesiology, 32(11), 812-818. 
doi:10.1097/eja.0000000000000299 
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3. Blanco, R., Ansari, T., Riad, W., & Shetty, N. (2016). Quadratus Lumborum Block Versus Transversus 
Abdominis Plane Block for Postoperative Pain After Cesarean Delivery. Regional Anesthesia and Pain 
Medicine, 41(6), 757-762. doi:10.1097/aap.0000000000000495 
4. Murouchi, T., Iwasaki, S., & Yamakage, M. (2016). Quadratus Lumborum Block: Analgesic effects and 
chronological ropivacaine concentrations after laparoscopic surgery. Regional Anesthesia and Pain 
Medicine, 41(2), 146-150. doi:10.1097/aap.0000000000000349 
5. Johnston, D. F., & Sondekoppam, R. V. (2016). Continuous quadratus lumborum block analgesia for 
total hip arthroplasty revision. Journal of Clinical Anesthesia, 35, 235-237. 
doi:10.1016/j.jclinane.2016.08.002 
6. Chin, K. J., Forero, M., & Adhikary, S. D. (2017). Single-shot Quadratus Block for Postoperative 
Analgesia After Minimally Invasive Hip Arthroplasty A New Alternative to Continuous Lumbar Plexus 
Block . Regional Anesthesia and Pain Medicine, 42(1), 125-126. Retrieved October 16, 2017. 
7. Kadam, V. (2013). Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique 
for laparotomy. Journal of Anaesthesiology Clinical Pharmacology, 29(4), 550. doi:10.4103/0970-
9185.119148 
8. L. Carline, G. A. McLeod, C. Lamb, and L. Colvin, “A cadaver study comparing spread of dye and 
nerve involvement after three different quadratus lumborum blocks,” British Journal of Anaesthesia, 
vol. 117, no. 3, pp. 387–394, 2016. 
9. Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, McDonnell JG. Studies on the spread of local 
anaesthetic solution in transversus abdominis plane blocks. Anaesthesia 2011; 66: 1023–30. 
 
 
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