Clinical trial NCT05506930
Conditions: Pain Control Ureteral Reimplantation Pediatrics Intrathecal Morphine
Sponsor: Medical University of South Carolina
Start date: 2022-08-17; Completion date: 2024-05-10
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.

Detailed description:

Arms: arm 1: Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg arm 2: Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Interventions: intervention 1: Intrathecal Morphine intervention 2: Quadratus lumborum block
Intervention descriptions: intervention 1: One group of subjects will receive intrathecal morphine: spinal (neuraxial) dose of preservative free morphine (Duramorph), usually about 4-5mcg/kg. This is injected into the cerebrospinal fluid under sterile technique by a pediatric anesthesiologist while the subject is already under general anesthesia. This procedure is well-described in the pediatric population and used regularly for postoperative pain relief for a variety of procedures including ureteral reimplantation. intervention 2: The second group of subjects will have bilateral quadratus lumborum blocks: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per/ kg per side (total dose approximately 1mL/kg). This is injected in the subject's flank in the fascial plane between the quadratus lumborum muscle and the psoas muscle. Ultrasound guidance is used for needle and structure localization and this procedure is done by a pediatric anesthesiologist while the subject is already under general anesthesia. Quadratus lumborum blocks are regularly used in clinical practice for postoperative pain relief for a variety of abdominal procedures.

Protocol documents:
Prot_SAP_ICF_000.pdf: 
Intrathecal Morphine versus Bilateral Quadratus Lumborum Blocks for Perioperative 
Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A 
Prospective Randomized Trial 
NCT05506930 
   July 13, 2023


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PROTOCOL TITLE: 
Intrathecal Morphine versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in 
Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized 
Trial 
 
PRINCIPAL INVESTIGATOR: 
Natalie R. Barnett, M.D. 
 
 
 


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• 
Objectives / Specific Aims 
• 
We hypothesize that intrathecal morphine will have superior analgesia as 
demonstrated by charted pain scores and morphine equivalents in the first 24 hours. 
• 
We hypothesize that intrathecal morphine will have higher incidence of side effects 
when compared to quadratus lumborum blocks 
2.0 
Background 
Postoperatively, abdominal procedures are associated with significant somatosensory pain 
at the incision site and potential visceral discomfort. Systemic opioid medications were 
traditionally a critical component for adequate pain control but were also found to be a 
primary factor contributing to perioperative complications including nausea, vomiting, 
respiratory depression, and ileus1.  
To reduce systemic opioid administration, regional anesthesia began to play a key role in 
postoperative pain management for many different types of surgery in children and has 
done so commonly for at least the last 20 years. A collaborative group of institutions and 
investigators developed the Pediatric Regional Anesthesia Network to study the practice, 
risks, and incidence of complications in pediatric regional anesthesia [9]. This group of 21 
centers captures data from every regional technique done for children at these hospitals 
(including neuraxial techniques like spinals, epidurals, and caudals as well as peripheral 
nerve blocks and peripheral nerve catheters) and has data on over 100,000 pediatric 
regional blocks. When looking at their database specifically for complications, they found 
that there were no incidences of permanent neurologic damage, transient neurologic 
symptoms occurred in 2.4/10,000 blocks, severe local anesthetic toxicity in 0.76/10,000 
blocks, and the most common complications were more benign issues like catheter 
dislodgement leading to block failure (4%)[11]. Comparatively, complications were more 
common in infants less than 6 months old, and this is consistent with other audits of 
regional anesthetics done by the French-Language Society of Pediatric Anesthesia, where 
the overall complication rate was found to be less than 0.1% with more prevalence in the 
less than 6-month-old population[5]. Further investigations on efficacy of regional 
anesthesia in pediatric patients has shown decreased need for narcotic pain medications 
when regional techniques are used. For abdominal surgeries in children, there is no specific 
standard of care for pain management – just that the anesthetic plan includes a plan for 
adequate perioperative pain management.  
Most abdominal surgeries will have a combination of analgesic modalities with non-
steroidal anti-inflammatories and regional anesthesia used to minimize narcotic 
administration and its associated sedation and side effects. The most common regional 
techniques used at MUSC for abdominal procedures are intrathecal morphine 
administration, abdominal wall blocks (including quadratus lumborum blocks), and 
epidurals. Epidurals also potentially lead to leg weakness (and subsequent patient 
dissatisfaction) and require increased monitoring at this institution.  
Intrathecal morphine has been shown to reduce total opioid consumption for a wide range 
of pediatric surgical procedures. However, significant rates of pruritis, emesis, and 
respiratory depression continued to be reported in a dose-dependent manner2. 
Subsequently, low-dose intrathecal morphine (3-5 mcg/kg) was investigated and shown to 
reduce the incidence of pruritis, emesis, and respiratory depression [1,4]. Fascial plane 
blocks have also been used for analgesia in abdominal and thoracic procedures in the 


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pediatric population to improve pain control and reduce postoperative narcotic 
administration. Quadratus lumborum blocks specifically provide analgesia for the 
abdominal wall (incisional pain) as well as some visceral pain relief (i.e., pain related to 
intraabdominal structures). The purpose of this study is to compare the postoperative 
analgesia provided by intrathecal morphine to that of bilateral quadratus lumborum blocks 
for open abdominal procedures. 
3.0 
Intervention to be studied  
• 
Each of the drugs used in this study have been FDA approved for the adult 
population. Although not approved for pediatric patients, they are commonly used as 
part of standard practice for pediatric analgesia and well-studied. 
• 
One group of subjects will receive intrathecal morphine: spinal (neuraxial) dose of 
preservative free morphine (Duramorph), usually about 4-5mcg/kg. This is injected 
into the cerebrospinal fluid under sterile technique by a pediatric anesthesiologist 
while the subject is already under general anesthesia. This procedure is well-
described in the pediatric population and used regularly for postoperative pain relief 
for a variety of procedures including open lower abdominal procedures.  
• 
The second group of subjects will have bilateral quadratus lumborum blocks: 
peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per/ kg per 
side (total dose approximately 1mL/kg). This is injected in the subject’s flank in the 
fascial plane between the quadratus lumborum muscle and the psoas muscle. 
Ultrasound guidance is used for needle and structure localization and this procedure 
is done by a pediatric anesthesiologist while the subject is already under general 
anesthesia. Quadratus lumborum blocks are regularly used in clinical practice for 
postoperative pain relief for a variety of open lower abdominal procedures.  
 
4.0 
Study Endpoints  
• 
The primary endpoint will compare the effect that intrathecal morphine and quadratus 
lumborum blocks have on the duration of analgesia as demonstrated by charted pain 
scores and morphine equivalents in the first 24 hours.  
• 
The secondary endpoint will assess the side effects of each intervention such as 
nausea and vomiting, and pruritis. Other secondary endpoints will include 
patient/family satisfaction, sedation, length of hospital stay, length of PACU stay, 
and analgesia for hospital stay (as approximated at 48 hours).  
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
Pediatric patients presenting to undergo ureteral reimplantation surgery will be the study 
population of interest. Surgery schedules in Epic will be screened for those undergoing this 
procedure at MUSCs Shawn Jenkins Children’s Hospital.  
Inclusion Criteria  
• 
Ages 12 months to 11 years old 
• 
Undergoing lower abdominal laparotomy 
Exclusion Criteria 


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• 
Allergy to morphine or amide local anesthetics 
• 
Localized rash at site of planned regional anesthetic block 
• 
Bleeding diathesis 
• 
Spinal dysmorphism 
• 
Previous spinal surgery with instrumentation of the lumbar spine 
• 
Inability or unwillingness of parent or legal guardian to give informed consent. 
• 
Prior enrollment and randomization in this study 
 
6.0 
Number of Subjects 
• 
We will enroll and randomize 30 subjects total. 
 
7.0 
Setting 
• 
The study will be conducted at all MUSC preoperative and inpatient locations which 
includes SJCH, Main (University Hospital), Ashley River Tower, and Rutledge 
Tower.  
 
8.0 
Recruitment Methods 
• 
The study team will refer to the clinic and OR schedules available in Epic to see 
which patients may qualify. If time allows during the pre-operative clinic visit, the 
surgeon will briefly introduce the study and provide an informational letter for the 
patient and family to take home.  
• 
If a potential research subject meets the inclusion criteria, the study team will contact 
the attending anesthesiologist who will be working the candidate’s case to make sure 
the anesthesia plan does not exclude the patient from the study.   
• 
The patient’s parents/guardians will be approached the day of surgery while in pre-op 
to discuss their willingness to participate in the study. 
 
9.0 
Consent Process 
Consent will be obtained by IRB approved study team members who have a medical 
degree and are qualified to discuss the clinical nature of the options being offered. 
• 
As mentioned in the previous section, potential study participants will be 
informed of the possibility of study participation by their surgeon performing 
the procedure at the time of discussion of surgery in clinic and be given an 
informational letter outlining the study. Contact will be made with the child’s 
parent or guardian on the day of the scheduled procedure to discuss the study in 
greater detail. The study will be explained, and the parent/guardian will be 
given time to read the consent thoroughly and ask any questions. This will 
happen in the patient’s private room or in the holding area.  
• 
Written informed consent will be obtained if the subject’s parent/guardian 
agrees to participate after the study is thoroughly explained. 


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• 
The consent will be obtained in the patient’s room or in the private bay in the 
holding area of MUSC’s SJCH.  
 
10.0 Study Design / Methods 
• 
This prospective, randomized, blinded study will attempt to determine if intrathecal 
morphine provides superior analgesia postoperatively for open lower abdominal 
procedures when compared to bilateral quadratus lumborum blocks. It will also 
assess side effects of both pain interventions. 
• 
Once a parent/guardian provide written informed consent, subjects will be assigned a 
number with a corresponding group. Randomization will be performed by a 
statistician prior to enrollment and assigned based on the patient’s enrollment 
number. Subjects will be assigned to one of the following groups: 1) Intrathecal 
Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), 
usually about 4-5mcg/kg, or 2) Quadratus Lumborum Block: peripheral nerve block 
utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose 
approximately 1mL/kg). The total dose of administered medication (duramorph or 
ropivacaine) is at the discretion of the anesthesiologist but will be within the dose 
range as stated above. 
• 
The operating room pharmacist will follow the randomization to prepare or provide 
the correct medication. Intrathecal morphine will be prepared by the operating room 
pharmacist. Local anesthetic vials for quadratus lumborum blocks will be obtained 
from the pharmacy and the medication will be drawn into a syringe by an 
anesthesiologist who is part of the research team prior to injection. The dosage 
prepared and administered will be based on weight.  
• 
The pharmacist will not be blinded to the randomization. Nor will the operative team. 
The study team member who completes data collection from the family and chart 
review will be blinded to randomization. In addition, the parent and child will also be 
blinded to the type of block that is used. 
• 
The intervention will be administered in the operating room after the subject is under 
general anesthesia but prior to incision, as per usual practice. The block will be 
performed by a study team member board certified in pediatric anesthesiology. 
Quadratus lumborum blocks are placed using ultrasound guidance, local anesthetic is 
injected in the fascial plane using aseptic technique. Intrathecal morphine is 
accomplished by injection of preservative-free morphine in the intrathecal space in 
the lumbar region using sterile technique. 
• 
Approximately 24 hours after the procedure, a research team member will ask the 
parent/guardian about side effects such as nausea, vomiting, itching, etc. The research 
team member will also ask the family if they were satisfied with the subject’s pain 
control postoperatively and overall experience. If a family member or guardian is not 
present, a care team member will be asked about side effects and the patient’s chart 
will be reviewed for notes pertaining to side effects.  
• 
The patient’s chart will be used to see if and how much narcotic pain medication was 
administered in the first 48 hours after the procedure as well as documented pain 
scores up to 48 hours after the procedure ends. The chart medication administration 
record will also be used to identify administration of rescue medications for nausea 


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or itching non-opioid medications such as acetaminophen or ibuprofen, or other 
medications such as diazepam or oxybutynin.   
 
 
 
 
 
 
 
 
 
 
12.0 Data Management  
• 
All data will be kept on a password protected MUSC server and in a REDCap 
database. All paper data sheets will be kept in a locked cabinet, in a locked office that 
only IRB approved study team members have access to. Participants will be given a 
study ID number that will be used to identify them throughout the study.  
• 
The primary outcome of interest is duration of analgesia as demonstrated by 
morphine equivalents per kg of body weight given in the first 24 hours after surgery. 
• 
Secondary outcomes observed include charted pain scores and reported side effects 
such as nausea/vomiting or pruritis in the first 48 hours as well as patient/family 
satisfaction, sedation, length of hospital stay, length of PACU stay, and analgesia for 
hospital stay, the numerical value for SPO2, SPO2 trend, and use or lack thereof of 
supplemental O2 in PACU in 15-minute intervals for up to two hours after arrival 
there.   
 
Demographic and clinical characteristics will be described and compared across the 
two groups using appropriate statistical tests (Chi-squared tests of homogeneity for 
categorical variables and t-tests for equality of means, etc.). Significant covariables 
will be assessed for inclusion in modeling. General linear regression methods will be 
Table 1. Baseline and Intraoperative Assessments 
Demographics 
Baseline 
Pre-op meds including opioids in past 24 hours 
Randomization 
Anesthesia intra-op data 
Surgical techniques 
Adverse Events 
Table 2. Post-Op Follow Up Assessments 
Outcome Measure 
Instrument 
Collected 
Pain Scores 
Charted pain scores 
24 and 48 hrs. post-op 
Pain Control Satisfaction 
Parent/Guardian Satisfaction 
24-hours post-op 
Side Effects Experienced 
Parent/Guardian Satisfaction 
24-hours post-op 
Overall Satisfaction 
Parent/Guardian Satisfaction 
24-hours post-op 
Opioid Consumption 
MME Consumption  
24 and 48 hrs. post-op 
Side Effects and Adverse Events 
Adverse Events 
Assessed through post-op hours 0-48 
Medications 
Medications used to control or relieve 
side effects 
24 and 48 hrs. post-op 


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used to assess the association of post-surgery MMEs with group (QL vs ITM) 
adjusted for associated covariables.    
Our primary hypothesis is that subjects in the two groups with consume different 
amounts of post-surgery MMEs. Based on preliminary data from a similar study, we 
assume that MME/kg consumption in the QL block group will be 0.07 ±0.076.  
 
Summary Statements 
 
Assuming a normal underlying distribution, group sample sizes of 12 and 12 achieve 
80% power to detect a difference of 0.1 MME/kg between the null hypothesis that 
both group means are 0.07 and the alternative hypothesis that the mean of group 2 is 
0.17 with known group standard deviation of 0.076 and with a significance level 
(alpha) of 0.05000 using a two-sided Mann-Whitney test. As we anticipate a non-
normal distribution, we will inflate sample size by 15%. We will inflate the sample 
size further by 10% to account for withdrawals.  
 
The final inflated sample size will be 15 per group.   
 
Two-tail test that QL < ITM 
H0= Mean QL = Mean ITM 
Ha= Mean QL <> Mean ITM 
 
13.0 Data Safety Monitoring 
 
• 
The study will be reviewed annually by the Department of Anesthesia’s DSMB.   
Minutes and outcomes from these meetings will be reported to the IRB as required. 
 
• 
Adverse events will be recorded and reported to the Department of Anesthesia’s Data 
Safety Monitoring Board and the IRB per policy. 
 
• 
PHI will be managed in a manner that complies with institutional rules and 
regulations.  There will be an enrollment log that links the study ID number to the 
patient.  This log will be kept on a MUSC password protected server that can only be 
accessed by IRB approved study personnel.  
 
 
14.0 Withdrawal of Subjects 
• 
If the anesthesiologist is unable to complete the regional anesthesia administration the 
patient will be withdrawn from the study. 
• 
If at any time the parent wishes to be withdrawn from the study, then the patient will 
be withdrawn. This can occur preoperatively or postoperatively when the parent is 
contacted by the research team approximately 24 hours after surgery. Any data 
collected prior to withdrawing will be retained.  
 
15.0 Risks to Subjects 


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• 
If a parent chooses for their child not to participate, the risk is the same since regional 
anesthesia is part of standard care at MUSC and will be offered regardless of study 
participation. Both study medications have been routinely used in practice at MUSC 
for over ten years. 
• 
Subjects will be assigned to receive intrathecal morphine or a quadratus lumborum 
block by chance. One group may prove to be less beneficial than the other. 
• 
Intrathecal Duramorph/Morphine: the use is well established in pediatric patients even 
though it is not FDA approved for use in children, but is commonly used in this 
population and at this institution for this indication. Other risks include infection at site 
of injection (less than 1%), damage to surrounding structures (less than 1%), block 
failure (1%) headache and cerebral spinal fluid leak (7%), Urinary retention (6%), 
Nausea and vomiting are the most common risks/side effects occurring in less than 
10% of patients. Itching occurs in 20-40% of patients. Literature states that patients 
recover from side effects and are not long term. 
 
QL Block/Ropivacaine: complications/risks are rare but include local anesthetic 
systemic toxicity (less than 0.01%), block failure (1%), bleeding and infection at block 
site (less than 1%), damage to surrounding structures (less than 1%), allergic reaction 
(rare, less than 1% ), neurological complications (less than 1%). Literature states that 
patients recover from side effects and are not long term. 
• 
There is a risk of loss of confidentiality.  
 
16.0 Potential Benefits to Subjects or Others 
• 
There are no direct benefits to subjects or their families for participation in this study.  
• 
There is a potential benefit that the subject’s participation in the study may contribute 
to knowledge of this area of practice and may impact patient care in the future. 
 
17.0 Sharing of Results with Subjects 
• 
Results will not be shared with participants or their families. 
 
18.0 Drugs or Devices  
• 
The intrathecal morphine will be prepared in the pharmacy by a licensed pharmacist 
under a sterile hood; the local anesthetic for quadratus lumborum block will be drawn 
immediately preceding the block from a sterile vial in a sterile operating room by a 
board-certified pediatric anesthesia attending participating in the study.  
• 
The contents of the injectate will be based off the patient’s randomly assigned group. 
• 
The pharmacist will not be blinded to the randomization. Nor will the operative team. 
The study team member who completes data collection from the family and chart 
review will be blinded to randomization, as well as the child and parent. 
• 
The drugs used in this study, morphine and ropivacaine, are FDA approved for use in 
this manner for adults; they have not been FDA approved for children, although they 
are used regularly as part of standard of care. Intrathecal morphine has been shown to 


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be safe in pediatric patients for major surgeries. In a recent retrospective study by 
Keskin et al [6], of 100 children who received 5 mcg/kg intrathecal morphine for 
major surgery for postoperative analgesia there were no serious adverse events 
(minor side effects of pruritis and nausea/vomiting seen in small number of patients, 
14 and 9 patients respectively). An additional retrospective review from CHOP of 
187 pediatric patients concluded that ITM in this population is a useful and safe 
analgesic adjunct [4]. The usage of intrathecal morphine in pediatric patients 
undergoing major spinal surgery is well established and without report of major 
adverse events [7,8]. Ropivacaine use is well established in pediatric patients, whether 
administered neuraxially (epidural or caudal) or for peripheral nerve block. The 
European Society of Regional Anesthesia and American Society of Regional 
Anesthesia published a joint recommendation on local anesthetic use for 
regional/neuraxial anesthesia in pediatric patients which included dosing strategies 
for ropivacaine [10]. 
 
References 
1. Borgeat A, Ekatodramis G, Schenker CA. Postoperative Nausea and Vomiting in Regional 
Anesthesia. Anesthesiology. 2003;98(2):530-547. doi:10.1097/00000542-200302000-00036 
2. Cravero JP, Agarwal R, Berde C, et al. The Society for Pediatric Anesthesia recommendations for 
the use of opioids in children during the perioperative period. Pediatric Anesthesia. 
2019;29(6):547-571. doi:10.1111/pan.13639 
3. Gall O, Aubineau J-V, Bernière J, Desjeux L, Murat I. Analgesic Effect of Low-dose Intrathecal 
Morphine after Spinal Fusion in Children. Anesthesiology. 2001;94(3):447-452. 
doi:10.1097/00000542-200103000-00014 
4. Ganesh A, Kim A, Casale P, Cucchiaro G. Low-Dose Intrathecal Morphine for Postoperative 
Analgesia in Children. Anesthesia & Analgesia. 2007;104(2):271-276. 
doi:10.1213/01.ane.0000252418.05394.28 
5. Giaufré E, Dalens B, Gombert A. Epidemiology and morbidity of regional anesthesia in children: 
a one-year prospective survey of the French-Language Society of Pediatric Anesthesiologists. 
Anesth Analg. 1996 Nov;83(5):904-12. doi: 10.1097/00000539-199611000-00003. PMID: 
8895261 
6. Keskin G, Akın M, Şenaylı Y, Öztorun Cİ, Bahçecitapar M. Effects of 5 µg/kg intrathecal 
morphine for postoperative analgesia in pediatric patients undergoing major surgery. Anaesthesist. 
2021 Sep 21. English. doi: 10.1007/s00101-021-01040-4. Epub ahead of print. PMID: 34549311. 
7. Musa A, Acosta FL, Tuchman A, Movahedi R, Pendi K, Nassif L, Farhan SA, Muallem E, Gucev 
G. Addition of Intrathecal Morphine for Postoperative Pain Management in Pediatric Spine 
Surgery: A Meta-analysis. Clin Spine Surg. 2019 Apr;32(3):104-110. doi: 
10.1097/BSD.0000000000000782. PMID: 30789492. 
8. Poe-Kochert C, Ina JG, Thompson GH, Hardesty CK, Son-Hing JP, Rubin K, Tripi PA. The safety 
and efficacy of intrathecal morphine in pediatric spinal deformity surgery: a 25-year single-center 
experience. Spine Deform. 2021 Sep;9(5):1303-1313. doi: 10.1007/s43390-021-00320-8. Epub 
2021 Mar 11. PMID: 33704687. 
9. Polaner DM, Taenzer AH, Walker BJ, Bosenberg A, Krane EJ, Suresh S, Wolf C, Martin LD. 
Pediatric Regional Anesthesia Network (PRAN): a multi-institutional study of the use and 
incidence of complications of pediatric regional anesthesia. Anesth Analg. 2012 Dec;115(6):1353-
64. doi: 10.1213/ANE.0b013e31825d9f4b. Epub 2012 Jun 13. PMID: 22696610. 
10. Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de 
Andrés J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American 
Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and 


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Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-
216. doi: 10.1097/AAP.0000000000000702. PMID: 29319604. 
11. Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, 
Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, 
Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, 
Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, 
Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, 
Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, 
Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, 
Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications 
in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric 
Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 
10.1097/ALN.0000000000002372. PMID: 30074928. 
 
 


Page 1 of 6 
Version Date: 03-30-2023 
IRB Number: Pro00121082 
Date Approved 5/2/2023 
 
 
Medical University of South Carolina 
CONSENT TO BE A RESEARCH SUBJECT 
 
TITLE OF RESEARCH: Intrathecal Morphine versus Bilateral Quadratus Lumborum Blocks for 
Perioperative Analgesia in Pediatric Patients Undergoing  Open Lower 
Abdominal Procedures: A Prospective Randomized Trial 
 
Your child is being asked to volunteer for a research study because they are undergoing an open 
lower abdominal procedure. The purpose of this study is to compare two different interventions to 
help with perioperative pain control. The two interventions are 1) intrathecal morphine or 2) a bilateral 
quadratus lumborum block. Each of these interventions are commonly used, and safe and effective in 
children. Your child will be randomly assigned  (like the flip of a coin) to which intervention they 
receive.  Neither you nor the study doctor will determine which of the two interventions will be used, 
nor will you or some members of the study team know which intervention your child receives. 
Whether or not your child participates in this study, they will be receiving one of the types of 
anesthesia as it is standard treatment for this procedure. 
 
Intrathecal (spinal) morphine injection occurs after the child is fully asleep under general anesthesia 
in the operating room. They are placed on their side and their back is cleaned. A needle is inserted 
into the space containing the cerebral spinal fluid and morphine is injected.  
 
Quadratus lumborum blocks are also placed once fully asleep in the operating room. After cleaning 
the area, ultrasound guidance is used to advance a needle between the muscle layers of the patient’s 
abdominal wall/side and local anesthetic (numbing medication) is injected. 
 
Approximately 24 hours after your child's surgery, the research team will ask you about your 
satisfaction with your child's recovery after surgery.  The following day the research team will collect 
information on how much pain medication your child received and any side effect they may have had. 
 
Study participation will start the day of your child’s surgery and will end approximately 48 hours later. 
 
The risks of participating include those of the intervention your child is randomized to and loss of 
confidentiality.  Those risks are described in section D of this document. The alternative is for your 
child to not participate and receive the type of anesthesia their provider chooses.   
 
A. PURPOSE OF THE RESEARCH 
Your child is being asked to participate in this research because he or she is scheduled for an open 
lower abdominal procedure, and a regional anesthetic block is going to be a standard and planned 
part of their care.  
Please read this consent form carefully and take your time making your decision. As your child’s 
study doctor or study staff discusses this consent form with you, please ask him/her to explain any 
words or information that you do not clearly understand. The investigator in charge of this study at 


Page 2 of 6 
Version Date: 03-30-2023 
IRB Number: Pro00121082 
Date Approved 5/2/2023 
MUSC is Dr. Natalie Barnett. This study is being done at the Medical University of South Carolina 
(MUSC). Approximately 30 people will take part in this study at MUSC. 
 
 
B. PROCEDURES 
If you agree for your child to be in this study, the following will happen: 
1. Some of your child’s demographic and personal information will be collected from their medical 
record such as age, height, weight, and other information from surgery.  
2. Your child will be randomly assigned to one of two groups, like flipping a coin. Neither you, your 
child, or the researchers will have a choice in which group your child is assigned to. Depending on 
which group your child is assigned, they will receive one of two types of regional anesthesia 1) 
intrathecal morphine or 2) quadratus lumbar block. Both interventions are placed once your child 
is already fully asleep and unaware under general anesthesia.  Intrathecal (spinal) morphine 
injection occurs after the child is fully asleep under general anesthesia in the operating room. 
They are placed on their side and their back is cleaned. A needle is inserted into the space 
containing the cerebral spinal fluid and morphine is injected. Quadratus lumborum blocks are also 
placed once fully asleep in the operating room. After cleaning the area, ultrasound guidance is 
used to advance a needle between the muscle layers of the patient’s abdominal wall/side and 
local anesthetic (numbing medication) is injected. 
3. Approximately 24 hours after your child’s surgery ends, someone from the research team will 
contact you to ask a few questions about your satisfaction of your child’s recovery after surgery.  
 
4. We will record what medications are provided up to 48 hours after the surgery is complete, any 
side effects that occur and how they are treated, as well as additional data recorded in the post-
anesthesia recovery unit. 
 
C. DURATION 
Participation in the study will take the time in the operating room, post-anesthesia care unit, as well as 
approximately up to 24 hours after the surgery ends.  
 
 
D. RISKS AND DISCOMFORTS 
 
Loss of confidentiality: there is a risk of a loss of confidentiality of your child’s personal information as 
a result of participation in this study, but all study team members are trained in the importance of 
protecting privacy and will do everything possible to minimize this risk. Your child will be assigned a 
study ID number, which will replace their name on study related documents to further protect their 
information, and only the research staff will have access to study information.  
 
Randomization: Your child will be randomized to receive one of two treatments. One treatment may 
prove to be less beneficial than the other. 


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QL Block/Ropivacaine: complications/risks are rare but include local anesthetic systemic toxicity (less 
than 0.01%), block failure (1%), bleeding and infection at block site (less than 1%), damage to 
surrounding structures (less than 1%), allergic reaction (rare, less than 1%), neurological 
complications (less than 1%). Literature states that patients recover from side effects and are not long 
term. 
 
Intrathecal Duramorph/Morphine: the use is well established in pediatric patients even though it is not 
FDA approved for use in children, but is commonly used in this population and at MUSC for this 
reason. Other risks include infection at site of injection (less than 1%), damage to surrounding 
structures (less than 1%), block failure (1%) headache and cerebral spinal fluid leak (7%), Urinary 
retention (6%), Nausea and vomiting are the most common risks/side effects occurring in less than 
10% of patients. Itching occurs in 20-40% of patients. Literature states that patients recover from side 
effects and are not long term. 
 
 
E.  MEDICAL RECORDS AND/OR CERTIFICATE OF CONFIDENTIALITY 
Results of research tests or procedures including which type of anesthesia your child received will be 
included in their MUSC medical record. All information within their medical record can be viewed by 
individuals authorized to access the record. We will make every effort to keep confidential all research 
information in the medical record that identify your child to the extent allowed by law. 
 
 
F. BENEFITS 
There is a potential benefit that your child’s participation in the study may contribute to knowledge of 
this area of practice and may impact patient care in the future. Additionally, one treatment may prove 
to have fewer side effects than the other. 
 
G. COSTS 
There will be no additional cost to you for procedures required in this research study.  All routine 
clinical care that you would have undergone without participation in the study, including testing and 
procedures, will be billed to you/your insurance company. 
 
Some insurance plans will not pay for these services for people taking part in research studies.  You 
will be responsible for any charges that your insurance does not cover including co-payments and 
deductibles. 
 
H. PAYMENT TO PARTICIPANTS 
Your child will not be paid for participating in this study. 
 
I. ALTERNATIVES 
The alternative to participating in this study is to not participate. Therefore, your child will instead  
receive the block that your child’s anesthesiologist prefers to use. 


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J. DATA SHARING 
Information about your child (including your identifiable private information) may have all of their 
identifiers removed and used for future research studies or distributed to other researchers for future 
research without additional informed consent from your child or their legally authorized 
representative. 
 
K. DISCLOSURE OF RESULTS 
Results will not be shared with your child or your family.   
 
L. AUTHORIZATION TO USE AND DISCLOSE (RELEASE) MEDICAL INFORMATION 
As part of this research study, your child’s study doctor and his/her research team will keep records of 
their participation in this study. 
 
The health information MUSC may use or disclose (release) for this research study includes 
information in your medical record, results of physical exams, medical history, lab tests or certain 
health information indicating or relating to your condition.  
 
Your study doctor and his/her research team will use and disclose (release) your health information to 
conduct this study. The health information listed above may be used by and/or disclosed (released) to 
the following, as applicable: 
 
• 
The sponsor of the study including its agents such as data repositories or contract research 
organizations monitoring the study; 
• 
Other institutions and investigators participating in the study; 
• 
Data Safety Monitoring Boards; 
• 
Accrediting agencies; 
• 
Clinical staff not involved in the study whom may become involved if it is relevant; 
• 
Parents of minor children if less than 16 years old.  Parents of children 16 years old or older 
require authorization from the child; or 
• 
Health insurer or payer in order to secure payment for covered treatment; 
• 
Federal and state agencies and MUSC committees having authority over the study such 
as: 
 
o The Institutional Review Board (IRB) overseeing this study;  Committees with 
quality improvement responsibilities;  Office of Human Research Protections; 
Food and Drug Administration;  National Institutes of Health or Other 
governmental offices, such as a public health agency or as required by law. 
 
Those persons who receive your health information may not be required by Federal privacy laws 
(such as the Privacy Rule) to protect it and may share your information with others without your 
permission, if permitted by laws governing them.   You do not have to sign this consent form.  If you 
choose not to sign, it will not affect your treatment, payment or enrollment in any health plan or affect 
your eligibility for benefits.  However, you will not be allowed to be a participant in this research study. 


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You will be given a copy of this consent form.  Your authorization will expire at the conclusion of this 
study or, if you are participating in a study designed for the development of a drug or device, your 
authorization will remain in effect until the drug or device is approved by the FDA or until the 
company’s application to study the drug/device is withdrawn.   You have the right to withdraw your 
agreement at any time.  You can do this by giving written notice to your study doctor.  If you withdraw 
your agreement, you will not be allowed to continue participation in this research study.  However, the 
information that has already been collected will still be used and released as described above.  You 
have the right to review your health information that is created during your participation in this study.  
After the study is completed, you may request this information. 
 
Your health information will be used or disclosed when required by law.  Your health information may 
be shared with a public health authority that is authorized by law to collect or receive such information 
for the purpose of preventing or controlling disease, injury or disability and for conducting public 
health surveillance, investigations or interventions.  No publication or public presentation about the 
research study will reveal your identity without another signed authorization from you.   
 
If you have questions or concerns about this Authorization or your privacy rights, please contact 
MUSC’s Privacy Officer at (843) 792-8740.   
 
Regulations require that you be given a copy of the MUSC Notice of Privacy Practices (NPP) 
describing the practices of MUSC regarding your health information. One can be found at the end of 
this form. 
 
M. CLINICAL TRIALS.GOV  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will include 
a summary of the results. You can search this Web site at any time. 
 
Results of this research will be used for the purposes described in this study. This information may be 
published, but your child will not be identified. Information that is obtained concerning this research that 
can be identified with your child will remain confidential to the extent possible within State and Federal 
law. The sponsor and the Food and Drug Administration (FDA) will receive copies of the research 
records. The investigators associated with this study, employees of the sponsor, the FDA, and the 
MUSC Institutional Review Board for Human Research will have access to identifying information. All 
records in South Carolina are subject to subpoena by a court of law. 
 
In the event that your child is injured as a result of participation in this study, you should immediately 
take your child to the emergency room of the Medical University Hospital, or in case of an emergency 
go to the nearest hospital and tell the physician on call that your child is in a research study. They will 
call your child’s study doctor who will make arrangements for your child’s treatment. If the study sponsor 
does not pay for your child’s treatment, the Medical University Hospital and the physicians who render 
treatment to your child will bill your insurance company. If your insurance company denies coverage or 
insurance is not available, you will be responsible for payment for all services rendered to your child. 
 


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Your child’s participation in this study is voluntary. Your child may refuse to take part in or stop taking 
part in this study at any time. You should call the investigator in charge of this study if your child decides 
to do this. Your child’s decision not to take part in the study will not affect your child’s current or future 
medical care or any benefits to which your child is entitled. 
 
The investigators and/or the sponsor may stop your child’s participation in this study at any time if they 
decide it is in your child’s best interest. They may also do this if your child does not follow the 
investigator’s instructions. 
 
Volunteers Statement 
 
I have been given a chance to ask questions about this research study. These questions have been 
answered to my satisfaction. If I have any more questions about my child’s participation in this study or 
study related injury, I may contact Dr. Natalie Barnett at 843-792-5454. I may contact the Medical 
University of SC Patient and Family Care Liaison (843) 792-5555 concerning medical treatment. 
 
If I have any questions, problems, or concerns, desire further information or wish to offer input about 
my child’s rights as a research subject in this study, I may contact the Medical University of SC 
Institutional Review Board for Human Research IRB Manager or the Office of Research Integrity 
Director at (843) 792- 4148. This includes any questions about my rights as a research subject in this 
study. 
 
I agree for my child to participate in this study. I have been given a copy of this form for my own records. 
 
If you wish to participate, you should sign below. 
 
 
 
________________________________ 
Signature of Person Obtaining Consent Date *Name of Participant  
 
 
Participant’s Personal Representative (if applicable):  
 
___________________________________________________   
Name of Personal Representative (Please print) 
 
___________________________________________________ 
 
Signature of Personal Representative 
 
Date 
 
 
Relationship:  ___ Spouse       ___ Parent               ___Next of Kin         ___Legal Guardian* ____ 
DPOA for Healthcare* 
 
*(If you are the health care agent or guardian, please provide proof of your authority to act on behalf of the 
patient