Comparison of Quadratus Lumborum Block With Medical Management for Pain Control After Lumbar Spine Fusion Surgery
Phase: PHASE3
Conditions: Pain, Opioid Use, Lumbar Disc Herniation
Sponsor: University of Massachusetts, Worcester

 INVESTIGATOR STUDY PLAN - REQUIRED 
 C  OMPARISON  OF  Q  UADRATUS  L  UMBORUM  B  LOCKS  WITH  M  EDICAL  M  ANAGEMENT 
 FOR  P  AIN  C  ONTROL  AFTER  L  UMBAR  S  PINE  F  USION  S  URGERY 
 NCT04588389 
 S  EPTEMBER  17, 2018 
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 1. T  ITLE 
 Comparison of Quadratus Lumborum Block with Medical Management for Pain Control after 
 Lumbar Spine Fusion Surgery 
 2. E  XTERNAL  IRB R  EVIEW  H  ISTORY * 
 “NA.” 
 3. P  RIOR  A  PPROVALS : 
 Departmental provisional approval.  The Chair of Orthopedics has approved the project and we 
 will only enroll subjects of the sub investigators listed on the project. 
 Conflict of Interest (COI): 
 No Conflict of Interest. 
 4. O  BJECTIVES * 
 The objective of the study is to compare the opioid sparing effect and the quality of analgesia of quadratus 
 lumborum plane block types 2 and 3 to systemic pharmacological management for postoperative pain 
 control after lumbar spinal fusion. 
 Hypothesis: 
 Quadratus Lumborum plane block, when added to multimodal pharmacological management, will result 
 in a reduced amount of opioids used postoperatively and better postoperative pain control than systemic 
 pharmacological treatment alone. 
 5. B  ACKGROUND * 
 Patients undergoing spinal fusion surgery experience severe postoperative pain.[1] Inadequate 
 pain control increases their morbidity and the development of complications. It also delays 
 postoperative mobilization, rehabilitation and overall patient satisfaction with their perioperative 
 experience.[2]  The problem is compounded in opioid tolerant patients who need double or triple 
 the amount of opioids needed to control the pain compared to the opioid naïve patients.  [3, 4] 
 The excessive use of opioids for postoperative pain management is one of the causes of the 
 current opioid epidemic. Finding ways that can potentially reduce opioid consumption would be 
 a valuable step in curbing this problem. Regional anesthesia using local anesthetics block the 
 pain transmission from the injured site to the brain. It can provide excellent analgesia and help 
 reduce systemic opioid consumption  thereby reducing side effects. [5] 
 Lumbar spine innervation comes from thoracolumbar nerves originating from the spinal cord. 
 The spine is divided anatomically into ventral, lateral and dorsal compartments in relation to 
 intervertebral foramina. The ventral and the lateral compartments are supplied by the lumbar 
 ventral rami of the spinal nerves and the lumbar plexus. The dorsal compartment is innervated 
 by branches of the dorsal rami of the spinal nerves.[6] 
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 Treating postoperative pain from spinal fusion postoperative at UMMC  is similar to other 
 facilities that perform this procedure. The most commonly used treatment is multimodal 
 medical management. The multimodal medical management uses opioid and non opioid 
 medications, orally or intravenously. Opioids constitute the main componenet of treatment  due 
 to  the severity of the pain and ceiling effect of the other non opioid medications. Finding a 
 pain management  method that can reduce the needed doses of opioids and improve the quality 
 of  pain relief is important.  Case reports of using the quadratus lumborum block for pain relief 
 after spinal surgery have shown promising results [10]. 
 The Quadratum Lumborum Block (QL) is a fascial plane block that is successfully used for 
 treating postoperative pain for abdominal wall surgery. Local anesthetics are deposited between 
 the QL muscle and the plane formed by the thoracolumbar fascia (TLF). Currently, there are 
 three types of the QL block. In the QL1 block, where the local anesthetic medications are 
 deposited anteriorly on the lateral edge of the QL muscle. In QL 2 blocks they are deposited in 
 the plane of the middle TLF posterior to the muscle. In the QL 3, they are deposited on the 
 anteromedial aspect of the QL muscle and behind the psoas major muscle in the plane created 
 by the anterior TLF. 
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 The numbers on the arrows point to the type of block, 1 = QL1, 2= QL 2, 3= QL 3 Block 
 Red is QL 2, Blue is the QL3 
 It is thought that this nerve block works by local interruption of the impulse transmission as the 
 nerves traverse the plane and also, by backtracking of the medication to the intervertebral 
 foramina. Contrast studies of QL injections show that the contrast reaches the lower thoracic 
 and upper lumbar nerve roots.  For that reason,  It is hypothesized that the QL block works as a 
 paravertebral nerve block[7].  The QL 1 block does not seem to be beneficial in spine surgery 
 as the local anesthetics spreads anteriorly towards the abdomen and therefore not be included in 
 this study. [7, 8]   It is plausible that performing either a QL 2 or QL 3 block would result in 
 good pain relief by blocking the nerve roots and by the direct relaxation of the muscles that are 
 supplied by those nerves. The other values of the QL-block are the simplicity, and the absence 
 of major blood vessels in the area as well as the ability to perform it without interference with 
 the surgical site. 
 6. I  NCLUSION  C  RITERIA : 
 ⮚  Adult Patients undergoing lumbar spinal fusion surgery. 
 ⮚  Patients from 40-70 years. 
 Exclusion Criteria: 
 ⮚  Recent drug abuse 
 ⮚  History of illicit drug use 
 ⮚  Chronic pain patients not related to the back lesions. 
 ⮚  Opioid tolerant patients. 
 ⮚  Patients with any lower extremity weaknesses or deficits. 
 ⮚  Patients with ASA classification more than 3. 
 ⮚  Coagulopathy. 
 ⮚  Infection near or in the area of the block. 
 ⮚  Pregnant patients. 
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 ⮚  Uncooperative patients who refuse care which directly effects research participation or 
 clinical care. 
 ⮚  If the surgeon reports performing non-typical fusion, 
 ⮚  The presence of intraoperative complications like nerve injury or abnormal results of 
 neuromonitoring and extensive dissection. 
 ⮚  Vulnerable populations (prisoner, mental impairment / dementia, pregnant, etc.) 
 ⮚  Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control) 
 7.  S  TUDY -W  IDE  N  UMBER  OF  S  UBJECTS * 
 This study is a pilot study as part of planning for a larger randomized controlled trial. We plan to 
 enroll a total of 30 patients, with 10 patients randomly assigned in each group of the study. 
 Group I will receive multimodal pharmacological management (control group). Group II will 
 receive the QL II Block and group III will receive the QL III block in combination with 
 multimodal pharmacological Management. [9, 10] 
 8.  S  TUDY -W  IDE  R  ECRUITMENT  M  ETHODS * 
 After coordination with the orthopedic surgeons from the spine division, patients scheduled for 
 an elective lumbar spinal fusion will be identified and screened on the electronic charts by the 
 investigators. Patients who meet the inclusion criteria will be approached and provided with all 
 the study information in the presurgical evaluation (PSE), the spine surgery clinics, or the 
 hospital floor. Patients who agree will be asked to sign the informed consent. For those who need 
 more time to think or could not be reached physically but expressed interest to the surgeon, a 
 study team member will be contacted them by phone and provide all the information and the 
 patient will sign the informed consent on the day of surgery. The study will start as soon as the 
 IRB approves the protocol. The location of the study will be at the UMass Memorial Medical 
 Center, Memorial campus. 
 9. S  TUDY  T  IMELINES * 
 Patients are expected to participate in the study for the first 48 hours after surgery and the first 
 postoperative visit about 2 weeks from the time of surgery. The primary analyses are expected to 
 be completed 6 months after conclusion of the study.  This is intended to be a pilot study; we estimate 
 it to be completed 18 months from the IRB approval date. 
 10. S  TUDY  E  NDPOINTS * 
 Primary Outcome: 
 ●  Fifteen percent drop in MME dose of the opioids consumed at 12, 24, 36 and 48 hours. 
 Secondary Outcome: 
 ●  The NRS every six hours 0, 1, 6, 12, 18, 24, 30, 36, 42 and 48 recorded by nurses in the 
 EPIC flow sheet will be used to collect the data at the approximate time intervals. 
 ●  The amount of left-over opioid pills at 2 weeks in the follow up visit. 
 ●  The presence of any side effects will be reported. 
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 o  Nausea and vomiting 
 o  Sedation. 
 o  Motor weakness. 
 o  Excessive numbness or paraesthesia. 
 ●  Other side effects. 
 11. P  ROCEDURES  I  NVOLVED * 
 ●  After coordinating with the orthopedic surgeons from the spine division, potential 
 candidates will be contacted (in the clinics or the floor as above) and the study will be 
 thoroughly explained to them by the research staff, PI or sub investigators. 
 ●  Informed consent will be obtained from the patients who are willing to participate. 
 ●  All study patients will be randomized to receive either multimodal pharmacological 
 management only or with one of the 2 blocks- QL 2 block or QL 3 - using a sealed 
 envelope. 
 ●  The  study  patients  will  be  revaluated  before  surgery  and  their  consent  will  be 
 confirmed. 
 ●  Anesthesia  is  a  standard  general  anesthesia  where  opioids  will  be  used  based  on  the 
 discretion of the anesthesia provider. 
 ●  After their surgery is completed and the leg movement is tested, the patients will receive 
 the block in the operating room or in the post anesthesia care unit (PACU), their pain will 
 be evaluated and documented by the nurse caring for the patient. 
 ●  For  the  blinding  purposes,  the  patients  will  be  told  that  there  are  two  possible  sites  at 
 which  they  will  receive  the  block.  The  sites  will  be  either  in  the  operating  room  before 
 you  wake  up  from  anesthesia  or  in  the  PACU.  The  patients  on  the  medical  management 
 group  will  be  told  that  they  have  received  their  block  before  recovering  from 
 anesthesia,  the  PACU  nurse  will  be  told  the  same  as  well  to  make  him  or  her  blinded  as 
 a pain assessor. 
 ●  For  those  who  will  have  the  block,  the  procedure  will  be  as  follows:  the  hip  will  be 
 raised  on  the  side  of  the  block  and  the  area  between  the  iliac  crest  and  costal  margin  is 
 scrubbed  using  chlorhexidine  solution.  Under  complete  aseptic  technique  including  a 
 sterile  ultrasound  probe  sleeve  and  ultrasound  guidance,  20  ml  of  ropivacaine  0.25  % 
 will  be  injected  in  the  facial  planes  as  decided  by  the  randomization  envelope.  The 
 procedure will be repeated on the other side. 
 ●  The  patient’s  vital  signs  will  be  recorded  every  5  minutes  for  30  minutes  after  the 
 procedure. 
 ●  The  pain  score  will  be  recorded,  and  the  patient  will  be  examined  for  signs  of  sensory 
 and motor blockade after 1 h using the following score: 
 Muscle strength using the Medical Research Council (MRC Scale)[11] 
 0= Complete Paralysis 
 1=Minimal Contraction. 
 2=Active movement with gravity eliminated. 
 3=Weak contractions against gravity. 
 4= Active movement against gravity 
 5= Normal strength. 
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 The dermatomes will be tested for sensory blockade 
 using ice. See Figure 1. 
 Figure 1: Dermatomes of interest 
 Table I: Motor Blockade 
 R 
 L 
 Group of Muscles 
 MRC Muscle Strength 
 0 
 1 
 2 
 3 
 4 
 5 
 L2 
 Hip Flexors 
 L3 
 Knee Flexors 
 L4 
 Ankle Dorsiﬂexes 
 L5 
 Long toe Extensors 
 S1 
 Ankle plantar ﬂexors 
 All the patients will receive a multimodal pharmacological management comprised of the 
 following medications: 
 ●  Oral acetaminophen, intravenous Ketorolac (Toradol) and Gabapentin. 
 ●  Opioids: 
 ⮚  Oxycodone q 4 hours as needed based on the patient's pain 
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 Patients with pain 3-4 on NRS will receive 5 mg; pain from 5-7, they will receive 
 10 mg; pain from 8-10 they will receive 15 mg. 
 ⮚  As needed PRN intravenous hydromorphone 0.2 mg q 2hs. 
 12. D  ATA  AND  S  PECIMEN  B  ANKING * : 
 “NA” 
 13. Data Analysis and Management*: 
 The primary analysis of interest is the comparison of the reduction in morphine milligram 
 equivalent (MME) dose of opioids consumed between the multimodal pharmacological 
 management (control group) versus nerve block (QL II and QL III) groups. Specifically, we 
 hypothesize that people receiving a nerve block will have less opioid consumption per day for 48 
 hours than people receiving standard-of-care.  To answer this question, we will use a two-sample 
 t-test of means with unequal n’s comparing MME between the two groups (control vs nerve 
 block (QLII & QLIII)).  Although not directly powered to do so we will also determine if a 
 difference exists in MME doses between the two nerve block groups (QLII & QLIII) using a 
 similar approach as described above. 
 As a secondary outcome we will also utilize the Numeric Rating Scale for pain scores to be 
 measured every six hours for 48 hours (8 measurements).  We will compare pain scores between 
 control vs. nerve block groups using a repeated measures ANOVA model. We will also repeat 
 these analyses looking for a difference between all three groups. 
 Allocation of participants to study arms will be based on a permuted block scheme in which 
 treatment assignments are made within blocks so that numbers assigned to each treatment arm 
 are equal after a block has been filled.  Blocks of various sizes will be used in random order to 
 facilitate allocation concealment.  The randomization process will be facilitated using a prime 
 modulus multiplicative pseudo-random generator. 
 Secondary Outcome: 
 ●  The VRS every six hours 0, 1, 6, 12, 18, 24, 30, 36, 42 and 48 recorded by nurses in the EPIC 
 flow sheet will be used to collect the data at the approximate time intervals. 
 ●  The amount of left-over opioid pills at 2 weeks follow up visit. 
 ●  The presence of side effects will be reported. 
 o 
 Nausea and vomiting 
 o 
 Sedation: using Pasero Opioid-induced Sedation Scale (POSS) 
 ▪ 
 1 = Awake and alert 
 ▪ 
 2 = slightly drowsy, easily aroused Acceptable. 
 ▪ 
 3 = frequently drowsy, arousable, drifts off to sleep during the conversation. 
 ▪ 
 4 = Somnolent, minimal or no response to verbal and physical stimulation 
 o 
 Motor weakness. 
 o  Excessive numbness or paraesthesia 
 ●  Other side effects . 
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 14. P  ROVISIONS  TO  M  ONITOR  THE  D  ATA  TO  E  NSURE  THE  S  AFETY  OF  S  UBJECTS * 
 The principal investigator will be responsible to review the data periodically to assess the 
 outcome of the study. Severe complications related to the block like deep-seated infection, 
 hematoma formation that needs surgical intervention or irreversible leg weakness or nerve 
 damage will be reported immediately and may trigger suspension of research. 
 15. W  ITHDRAWAL  OF  S  UBJECTS  W  ITHOUT  T  HEIR  C  ONSENT * 
 “NA” 
 16. R  ISKS  TO  S  UBJECTS * 
 Patients might feel some discomfort on the introduction of the needle to place the block; 
 however, local anesthetic infiltration of the skin will be used to minimize this discomfort. Other 
 side effects are rare but can be in the form of a mild temporary leg weakness. The motor strength 
 of the lower extremities will be checked within the first one hour after the block. If leg weakness 
 does not happen in the first hour then it will not happen. During this period the patient will be in 
 the recovery room and under continuous monitoring 
 While rarely reported, if leg weakness should happen it will be mild and temporary due to the 
 low concentration of the local anesthetic, and the type of the local anesthetic we use. 
 Ropivacaine has preferential sensory blockade rather than motor blockade. We also will be using 
 the dilute form which is 0.25% of Ropivacaine and is known to have minimal motor blocking 
 properties if at all[12, 13].  As stated above, the motor strength of the lower extremities will be 
 checked one hour after the block, which will be sufficient time to show this potential side effect. 
 If it occurs it will present within the first hour after the block while the patient is in the recovery 
 room and under continuous monitoring.  Patients and the floor nurse will be made aware that that 
 patient should not move out of bed in absence of personal assistance. One of the investigators 
 will follow up with the patient until the weakness resolves. Other possible extremely rare risks 
 include infection, hematoma and persistent neuropathy. The patients will be examined every day 
 during their hospital stay.   After discharge the patients  will be able to contact the primary spine 
 surgery service that will notify the PI.   All the necessary intervention will be done as the case 
 dictates. 
 17. P  OTENTIAL  D  IRECT  B  ENEFITS  TO  S  UBJECTS * 
 The potential benefits to the patients are: 
 ●  Better pain relief following a significantly painful surgery. 
 ●  Reduced opioid use. 
 ●  Earlier participation in rehabilitation, faster recovery and hospital discharge. 
 18. V  ULNERABLE  P  OPULATIONS * 
 The study does not intend to include any vulnerable patients. 
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 19. M  ULTI -S  ITE  R  ESEARCH * 
 “NA” 
 20. C  OMMUNITY -B  ASED  P  ARTICIPATORY  R  ESEARCH * 
 “NA” 
 21. S  HARING  OF  R  ESEARCH  R  ESULTS  WITH  S  UBJECTS * 
 Upon conclusion of the study, patients can contact the study PI for the results of the study. 
 22. S  ETTING : 
 The study will take place locally at the UMASS Memorial Medical Center, Memorial campus. 
 Explanation of the study will take place in the PSE, spine clinic, the hospital floors, by the phone 
 and /or the in the preoperative holding area.  Nerve block procedures will be performed in the 
 post anesthesia care unit (PACU) after surgery is completed. The follow up will happen on the 
 hospital floor. 
 The data will be accessed and stored safely on a secured server. 
 23. R  ESOURCES  A  VAILABLE : 
 Specific anesthesiologists specialized in regional anesthesia will administer the nerve blocks for 
 all subjects involved in this study. 
 Roles 
 PI : The PI will plan the study, oversee the whole  process, perform some of the blocks, receive 
 the results, interpret the results after the statistical analysis is done and write the manuscript. The 
 PI is an anesthesiologist who is trained in the subspecialty of regional anesthesia. 
 Sub investigators:  Assist in the study planning, performing  the blocks, following the study and 
 writing the manuscript.  The co-investigators are anesthesiologists who are trained in the 
 subspecialty of regional anesthesia and orthopedic surgeons who operate on the patients. 
 Research coordinators/Nurse:  Will assist in formulating  the study plan, randomizing, 
 explaining the study to potential participants, and collection of data. The research coordinators 
 are nurses or research coordinators who are experienced in conducting research. 
 24. L  OCAL  R  ECRUITMENT  M  ETHODS 
 As a pilot study, we will plan to do 10 cases in each group. Patients will be screened for 
 eligibility based on the inclusion criteria and exclusion criteria, adult patients undergoing 2 or 
 more levels of lumbar fusion, with no chronic pain issues other than back pain. The patient’s 
 medical record number will be the identifier used to screen the patient records. Patients who 
 agree to participate will be evaluated and consented. Patients who turn out to be ineligible to 
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 participate after the initial consent will be informed of the reason. After the patient who enter the 
 study, will be given a study code and their data will be saved under that code and no identifier 
 will be linked to the data. 
 25. L  OCAL  N  UMBER  OF  S  UBJECTS :  We plan to enroll 30  subjects. 
 26. C  ONFIDENTIALITY 
 Data of each study patient will be collected by study members and entered in a spreadsheet. Each 
 coauthor will hand the data of the cases they do to the PI and the research coordinators. Only the 
 PI and the research coordinators will have access to all the data. The data will be stored in a 
 secure server location assigned to the study. Each patient data will be entered under a code 
 assigned to them. 
 The data that will be stored is the study patients are the following: 
 ⮚  Age 
 ⮚  Gender. 
 ⮚  Details of the surgical procedure: anterior/ lateral level and number of fusion, number of 
 levels fused. 
 ⮚  Type, dose of opioids used preoperatively and their MME doses. 
 ⮚  Type, dose of opioids used intraoperatively and their MME doses. 
 ⮚  Type and total MME doses every 12, 24, 36 and 48. 
 ⮚  Types and doses of non-opioids analgesics and adjuvants (e.g. Acetaminophen, 
 non-steroidal anti-inflammatory drugs, gabapentin, clonidine. 
 ⮚  Side Effects: 
 ●  Muscle weakness. 
 ●  Excessive numbness. 
 ●  Other side effects. 
 Storage:  The source data will be stored in the critical  care research office. The Critical Care 
 Research office is secured with a keypad lock. The combination is known only to authorized 
 individuals. The electronic data will be kept on UMASS secure servers and protected in a 
 database that is password protected and encrypted. Data will be stored in the password protected 
 secure files. 
 Each study patient data will be de-identified and given an ID number and all their data will be 
 saved under that ID. 
 Data:  All data will be transmitted to the PI and  the research coordinators who will store the data 
 on a secure server.  Data will be tabulated in excel tables. Descriptive statistics will be used 
 describe data. Comparison of data will be done using two-way ANOVA 
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 27. P  ROVISIONS  TO  P  ROTECT  THE  P  RIVACY  I  NTERESTS  OF  S  UBJECTS 
 A HIPAA waiver of authorization will be used to screen any subjects after the surgeons send the 
 patient names as appropriate candidates for this research study. The subjects will be made 
 comfortable and given enough privacy during and after all the steps of the research. Drapes and 
 curtains will be used during the procedure, local anesthetic medication will be used to infiltrate 
 the target pathway. Patient will be informed that they have the right to skip any question they 
 don’t wish to answer. 
 Only research personnel involved in the research study and trained to conduct the study related 
 procedures will be involved with the subjects. 
 28. C  OMPENSATION  FOR  R  ESEARCH -R  ELATED  I  NJURY 
 Neither subjects nor their insurance will be billed for research procedures.  The University of 
 Massachusetts Medical School does not provide funds for the treatment of research-related 
 injury. However, if the subject is injured as a result of their participation in this study, treatment 
 will be provided. The subject or their insurance carrier will be expected to pay the costs of this 
 treatment. No additional financial compensation for injury or lost wages is available. 
 29. E  CONOMIC  B  URDEN  TO  S  UBJECTS 
 Subjects will not incur any cost from being in the study.  All study related charges will be paid 
 internally through the department, as per the charges generated by Investigational Drug Services 
 (IDS). 
 30. C  ONSENT  P  ROCESS : 
 Where will the consent process take place:  The consent  process will take place in the 
 presurgical evaluation (PSE), the spine surgery clinics, or the hospital floor. 
 Any waiting period available between informing the prospective subject and obtaining 
 consent:  The subject will be given as much time as  possible to decide whether they would like to 
 participate in the research study. All questions will be discussed. If the subject is not comfortable 
 making a decision, the subject will not be enrolled. 
 Informed Consent Process:  The principal investigator  will ensure that informed consent is 
 obtained in accordance with the SOP: HRP-802 INVESTIGATOR GUIDANCE: Informed 
 Consent”. Those obtaining informed consent from the subject will be a PI, sub investigator, 
 research nurse, research nurse manager or research coordinator who has been properly trained by 
 the principal investigator, is knowledgeable about the study and able to answer any questions the 
 potential subject may ask. 
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 After discussing the study in detail (risks, procedures, follow-up) the subject will be given the 
 informed consent form to review. The subject will be asked if they understand what has been 
 explained. All questions will be discussed. If they are uncomfortable or hesitant about 
 participating in the research, the consent process will be stopped. If the subject is willing to 
 participate in the research, they will sign and date the informed consent form. The research staff 
 personnel obtaining consent will sign and date the forms where appropriate. A copy of the ICF 
 form will be given to the subject. The original ICF will be placed in the regulatory binder for the 
 research study. A copy of the ICF form will be placed in the subject’s medical record. 
 A note will be placed in the subject’s electronic medical record noting the following: 
 • The date and time that the informed consent form was signed 
 • Discussion of the study and questions answered 
 • That the subject met all study entry criteria 
 31. T  HE  PROCESS  TO  D  OCUMENT  C  ONSENT  IN  W  RITING 
 We will be following the “HRP-803 INVESTIGATOR GUIDANCE: Documentation of 
 Consent.” 
 32. D  RUGS  OR  D  EVICES : 
 The drug that is going to be used in the study is Ropivacaine 0.25% diluted in saline to 0.2 %. 
 The ultrasound machine will be used to guide the block. The study medication will be 
 administered by a licensed professional who is appropriately knowledgeable in the 
 administration of the study drug. All study drugs have been coordinated with Investigational 
 Drug Services. 
 References: 
 1 . 
 Bajwa, S.J. and R. Haldar,  Pain management following  spinal surgeries: An appraisal of 
 the available options.  J Craniovertebr Junction Spine,  2015. 6(3): p. 105-10. 
 2. 
 Wainwright, T.W., T. Immins, and R.G. Middleton,  Enhanced recovery after surgery 
 (ERAS) and its applicability for major spine surgery.  Best Pract Res Clin Anaesthesiol, 
 2016. 30(1): p. 91-102. 
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 Rapp, S.E., L.B. Ready, and M.L. Nessly,  Acute  pain management in patients with prior 
 opioid consumption: a case-controlled retrospective review.  Pain, 1995. 61(2): p. 
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 Mitra, S. and R.S. Sinatra,  Perioperative management  of acute pain in the 
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 Souzdalnitski, D., T.M. Halaszynski, and G. Faclier,  Regional anesthesia and co-existing 
 chronic pain.  Curr Opin Anaesthesiol, 2010. 23(5):  p. 662-70. 
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 Bogduk, N.,  The innervation of the lumbar spine.  Spine (Phila Pa 1976), 1983. 8(3): p. 
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 Carline, L., G.A. McLeod, and C. Lamb,  A cadaver study comparing spread of dye and 
 nerve involvement after three different quadratus lumborum blocks.  Br J Anaesth, 2016. 
 117(3): p. 387-94. 
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 Børglum J, et al.  Ultrasound-Guided Transmuscular  Quadratus Lumborum Blockade . 
 BJA, 2013. 
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 Bell, M.L., A.L. Whitehead, and S.A. Julious,  Guidance  for using pilot studies to inform 
 the design of intervention trials with continuous outcomes.  Clin Epidemiol, 2018. 10: p. 
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 Lancaster, G.A., S. Dodd, and P.R. Williamson,  Design and analysis of pilot studies: 
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 Paternostro-Sluga, T., et al.,  Reliability and  validity of the Medical Research Council 
 (MRC) scale and a modified scale for testing muscle strength in patients with radial 
 palsy.  J Rehabil Med, 2008. 40(8): p. 665-71. 
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 Lacassie, H.J., et al.,  The relative motor blocking  potencies of epidural bupivacaine and 
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