Quadratus Lumborum Block Versus Transversus Abdominus Plane Block for Pain Management After Donor Nephrectomy
Phase: NA
Conditions: Kidney Donor
Sponsor: Medical University of South Carolina

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Quadratus lumborum block versus transversus abdominus plane block for pain management after donor 
nephrectomy  
 
NCT 03476850  
 
 
April 17, 2019

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PI Name:  Eric Bolin MD 
 
Study Title:  Quadratus lumborum block versus transversus abdominus plane block for pain 
management after donor nephrectomy 
 
TABLE OF CONTENTS 
 
A. Specific Aims – Page 1 
B. Background and Significance – Page 1 
C. Preliminary Studies – Page 1 
D. Research Design and Methods – Page 2 
E. Protection of Human Subjects – Page 3 - 5 
F. References- Page 5 
 
 
 
A. SPECIFIC AIMS___________________________________________________________________________ 
 
The purpose of this study is to test a hypothesis. We hypothesize that quadratus lumborum (QL) block provides 
superior pain relief to the transversus abdominis plane (TAP) block during the first 24 hours after donor 
nephrectomy.   
 
B. BACKGROUND AND SIGNIFICANCE_________________________________________________________ 
 
Donor nephrectomy is an altruistic operation in which the donor graciously donates one healthy kidney to another 
individual with renal failure. Unfortunately, the surgery to remove the graft is often associated with significant pain 
for the donor.1,2 Over the years many techniques have been employed to reduce pain for the donor, including 
using laparoscopic versus open surgical techniques, multimodal analgesia, and a variety of regional anesthesia 
techniques.3-7 Currently at MUSC, post operative pain management for patients undergoing donor nephrectomy is 
provided by a combination of a quadratus lumborum or TAP block, multimodal analgesics, and narcotics. The 
quadratus lumborum block, is a more recently developed peripheral nerve block that promises to offer improved 
analgesia over TAP block.7,8 QL has been shown to provide superior analgesia in Caesarean sections9 and in 
pediatric patients undergoing lower abdominal surgery.10 Should the QL demonstrate superior analgesia than the 
TAP block, it may replace the TAP as the standard block for this surgery. Concerns in the postoperative course 
for laparoscopic donor nephrectomy patients include pain control and side effects from opioids, including nausea/ 
vomiting, constipation, and pruritis. Regional techniques have been included in early recovery after surgery 
protocols (ERAS) protocols for laparoscopic donor nephrectomy because they provide analgesia while preventing 
or circumventing some of these side effects. Should the QL be shown to provide superior analgesia, in the future 
it may be considered a component in such fast track protocols to facilitate faster time to discharge and decrease 
hospital length of stay.11 
 
Quadratus lumborum has been demonstrated to provide superior analgesia to TAP block in pediatric patients 
undergoing lower abdominal surgery and parturients undergoing Caesarean section, however no studies have 
compared these blocks in the laparoscopic donor nephrectomy population.9,10 
 
C. PRELIMINARY STUDIES___________________________________________________________________ 
 
Currently, at our institution, TAP or QL blocks are routinely performed for laparoscopic donor nephrectomy based 
on provider preference. Previous studies regarding quadratus lumborum block have been thoroughly reviewed.7-
10, 12-13 The principal investigator has previously completed a prospective, randomized clinical trial comparing the 
efficacy of regional anesthesia techniques for post operative pain management after total knee replacement 
surgery. The design of the proposed study is comparable to the previously completed study. 
 
 
Medical University of South Carolina 
Protocol 

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D. RESEARCH DESIGN AND METHODS (including data analysis) __________________________________ 
 
This will be a prospective randomized double-blinded trial to compare TAP block versus QL block for pain 
management in living donor nephrectomy patients.  Participants will be blinded to the type of block received and 
physicians will be blinded both intra- and post-op regarding which block patients received. The team who 
performs the block will know which block the patient received. No one else involved in the care of the patient will 
know. The surgery team will not know, and the primary (in the OR) anesthesia team will not know. None of the 
providers involved in post-operative care of the patient will know. 
It is expected that the QL block will provide superior pain control and for a longer duration.  Specifically, both 
groups are expected to show an increase in pain as the block wears off but those who received a TAP block are 
expected to show an earlier rate of pain increase. 
 
The primary outcome of interest will be patient reported pain on the 10 point NRS scale14 measured initially 
initially in the recovery room (PACU) and then collected at “random” times by the floor nurses up to the first 24 
hours post-op. Secondary outcomes will include opiate consumption over time, occurrence of side effects, 
occurrence of block related issues, PACU length of stay, and hospital length of stay (defined by time to meet 
discharge criterion).   
 
Patients meeting inclusion criteria will be given a copy of the consent document during their pre-op visit.  Consent 
will be obtained in holding on the day of surgery by an IRB approved, CITI certified study team member that has 
been trained on the protocol. Participants will be randomized to receive a bilateral TAP block or a bilateral QL 
block based upon a computerized randomization provided by our statistician. 
 
After informed written consent, as part of usual clinical care, monitors will be applied and sedation provided at the 
discretion of the block team. Blocks will be performed under the supervision of a regional anesthesia attending 
experienced in the performance of both the TAP and QL blocks. Both blocks will be performed using ropivacaine 
0.375% 20ml each side for a total volume of 40cc.  All patients will receive standard of care pain management.   
 
Inclusion: 
Patients undergoing laparoscopic assisted donor nephrectomy 
Patients that have elected to have a nerve block 
18 years of age or older 
Patients of ASA status I – III 
Exclusion criteria: 
Chronic pain or narcotic usage during the preceding 30 days 
Infection at or near the intended needle insertion site 
Complex or altered abdominal wall anatomy 
Weight <45kg 
 
Members of the research team will collect the following data via review of the electronic medical record: 
- 
Total dose narcotics administered during the intraoperative period in IV morphine equivalents 
- 
Total dose of narcotics administered in the recovery room in IV morphine equivalents 
- 
Total dose of narcotics administered during the first 24 hours following PACU discharge in IV morphine 
equivalents 
- 
Pain scores 
- 
Date and time of discharge in order determine length of stay 
 
Statistical Analysis: 
The primary outcome of this study is NRS pain score over the first 24 hours as described by a linear mixed model 
which accounts for variability in frequency and number of pain assessments.  
 
The primary outcome of interest is patient reported pain measured on a 10 point NRS scale over the first 24 hours 
post-op.  Comparison of patient reported pain over time between the two block groups will be evaluated using a 
linear mixed model approach.  The model will include fixed effects for block type, post-operative time, and a block 
by time interaction and a random subject effect to account for repeated measures on the same subject over time.  

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Various correlation structures will be considered and the final structure will be selected based on the model 
Akaike information criterion.15  We will test the hypothesis that pain measured over time differs between the two 
groups, specifically testing the hypotheses that the slopes of the lines for pain response over time between the 
two treatment groups are the same. In a study comparing patient reported pain in living donor nephrectomy, 
Hutchins et al. (2016) observed a median (IQR [range]) maximum patient reported NRS pain score of 6 (5-9 [0-
10]) and a median minimum NRS pain score of 3 (0-4 [0-8]) in living donors who received non-liposomal 
bupivacaine with a transverse abdominis plane block, which is similar to our control patient population.6  A sample 
size of 24 subjects per group (48 subjects total) provides 87% power to detect a 2 point difference in patient 
reported pain based on a 2-sided test and significance level α = 0.05 assuming at least 3 measures per patients 
and a within subject covariance having a compound symmetric structure with a standard deviation in pain score of 
3 points and within subject correlation of 0.5.  We will plan to enroll 52 patients (instead of 48) to account for some 
patients that may be withdrawn. If the within subject correlation is smaller or we have more than 3 measures on 
average per subject, we will be able to detect even smaller differences.  Additionally, Harrell’s rule of thumb states 
that 10 subjects per covariate are required to avoid overfitting.16 Thus the linear mixed model will also include up 
to 3 additional covariates, for example gender or amount of opiate consumed, in order to account for factors 
known to be associated with patient reported pain.  MUSC has approximately 35 living donor nephrectomy 
patients per year and we anticipate at least 80% (28 of 35) will agree to participate in the study, thus enrollment 
should be completed within 2 years. 
Secondary outcomes include include opiate consumption over time, occurrence of opioid side effects, occurrence 
of block related issues, PACU length of stay, and hospital length of stay.  Comparisons between the two block 
groups for cumulative opiate consumption over time will also be evaluated using a linear mixed model approach, 
similar to what is described for patient reported pain over time.  Comparisons between treatment groups for all 
categorical outcomes will be conducted using a chi-square test or Fisher’s exact test when appropriate.  
Differences between treatment groups for PACU and hospital LOS will be evaluated using a two-sample t-test or 
Wilcoxon rank sum test when appropriate. 
 
E. PROTECTION OF HUMAN SUBJECTS________________________________________________________ 
 
1. RISKS TO THE SUBJECTS  
 
a.  Human Subjects Involvement and Characteristics  
 
There will be a total of 52 adult (18 years or older) human subject candidates that have undergone an extensive 
evaluation process to become a candidate for organ donation. Donor nephrectomy candidates are typically 
healthy volunteers. Volunteers must have an ASA status I – III. Race, ethnicity, and gender will not be considered 
in subject selection. Special populations including children and other vulnerable patients will not be included in 
this study. There are no collaborating sites; this is a single center trial. 
 
Targeted/Planned Enrollment Table 
 
Total Planned Enrollment 52 
 
TARGETED/PLANNED ENROLLMENT: Number of Subjects 
Ethnic Category 
Sex/Gender 
Females 
Males 
Total 
Hispanic or Latino 
         
          
            
Not Hispanic or Latino 
         
          
            
Ethnic Category: Total of All Subjects* 
      
Racial Categories 
 
American Indian/Alaska Native 
      
      
      
Asian 
      
      
      
Native Hawaiian or Other Pacific Islander 
      
      
      
Black or African American 
      
      
      
White 
      
      
      
Racial Categories: Total of All Subjects* 
     26 
     26 
      

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*The “Ethnic Category: Total of All Subjects” must be equal to the”Racial Categories: Total of All Subjects”.  
 
Inclusion criteria include all patients of age 18 years or older, ASA class less than or equal to III, presenting for 
living laparoscopic donor nephrectomy at MUSC and consenting to participation in the study. Children will not be 
included in this study. No special classes of subjects will be involved in this study. Race, gender, and ethnicity will 
not be considered during subject selection. The estimated numbers of participants from ethnic groups, racial 
groups, and gender groups provided above are based solely on the demographics of the state of South Carolina. 
These are rough estimates. This study is a single institution study. 
 
b.  Sources of Materials  
 
For each subject included in the study, MRN, age, gender, height, and weight, pain scores, medication 
administration, and length of stay will be collected. Adverse events will be documented and reported to the IRB 
and the Department of Anesthesia’s DSMB per MUSC policy. All participants will be given a numeric identifier that 
will be used to identify subjects throughout the study. An electronic enrollment log will be kept on a password 
protected MUSC server and only trained, IRB approved study team members will have access to this information. 
 
c.  Potential Risks  
 
There is no increase of medical risk as patients receive nerve blocks during routine care for this surgery. Baseline 
risks of the intervention include bleeding, infection, damage to surrounding structures, nerve damage, and failed 
block. The risks for the two interventions are similar. 
 
The alternative is to not participate in the study and the patient will receive the nerve block their provider prefers. 
 
There is a risk of loss of confidentiality.  
 
2.  ADEQUACY OF PROTECTION AGAINST RISKS  
 
a.  Recruitment and Informed Consent 
 
Potential participants will be given a copy of the consent document during their pre-operative visit.  Patients will 
be given a chance to ask any necessary questions prior to surgery on the same day during their anesthesia 
workup, as customary for anesthesia. Once a potential participant agrees to volunteer in the study a trained, IRB-
approved member of the research team will obtain written consent and a signed HIPPA document.  Patients will 
be given copies of both documents for their records. Children will not be included in this study. 
 
b.  Protection against Risk 
 
Any adverse events related to placement of nerve blocks will be treated according to MUSC Hospital policy and 
procedures and the practice of the Department of Anesthesia. 
 
The Department of Anesthesia’s DSMB will review the study on an annual basis. Any adverse events will be 
reported and reviewed by the DSMB. Adverse events will be reported to MUSC’s IRB per policy. 
 
All data will be kept in a locked office, in a locked cabinet, and electronic data will be stored on a password 
protected MUSC server. Only CITI-certified, IRB approved study team members will have access to data.  
 
3.  POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS  
 
This study aims to determine whether newer regional anesthesia techniques are superior to current standard 
practice. The study may result in improved pain control for the subject, and eventually other kidney donors in the 
future. Other studies in other patient populations have reported improved pain control with lower blood 
concentration levels of local anesthetic.9,10,13 It is reasonable to anticipate that similar results would be 
demonstrated in this patient population. The risks to the subject are reasonable to the extent that the patients will 
undergo standard anesthetic management for laparoscopic donor nephrectomy at our institution. 
 
4.  IMPORTANCE OF THE KNOWLEDGE TO BE GAINED  
 

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Renal failure is a widespread condition throughout the community. A limited supply of organs is available for 
transplantation, however. Living donation represents a large area to increase the available supply of 
transplantable kidneys. For many potential donors fear of pain is often a limiting factor in volunteer decisions to 
donate. By potentially improving postoperative analgesia, more volunteers may be encouraged to consider living 
kidney donation.11 
 
5.  SUBJECT SAFETY AND MINIMIZING RISKS (Data and Safety Monitoring Plan) 
 
Any adverse events related to placement of nerve blocks will be treated according to MUSC Hospital policy and 
procedures and the practice of the Department of Anesthesia. 
 
Nerve blocks will be performed in the customary fashion in order to minimize the risks of adverse outcomes. 
Patients will be monitored by the anesthesia care team for adverse events. The anesthesia team is skilled in the 
management related to the placement of nerve blocks.  
 
The study will be reviewed annually by the Department of Anesthesia’s DSMB.   
 
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. 
 
*Clinical Trials 
A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to 
answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways 
of using known drugs, treatments, or devices).  
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and 
effective.  Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, 
cognitive therapy, etc.) fits these criteria of a clinical trial.  Human subjects research to develop or evaluate clinical 
laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will 
be used for medical decision-making for the subject or the test itself imposes more than minimal risk for subjects. 
 
F. REFERENCES/LITERATURE CITATIONS______________________________________________________ 
 
1. Thiyagarajan U, Bagul A, Nicholson M. Pain Management in Laparoscopic Donor Nephrectomy: A 
Review. Pain Res Treat. 2012: ePub 2012. DOI: 10.1155/2012/201852. 
2. Gorevski E, Wead S, Tevar A, et al. Retrospective Evaluation of Donor Pain and Pain Management After 
Laparoscopic Nephrectomy. Transplantation Proceedings. 43: 2487-2491. 
3. Milan Z, Das S, Kocarev M, et al. Is Single-Shot Epidural Analgesia More Effective Than Morphine 
Patient-Controlled Analgesia for Donor Nephrectomy? Transplantation Proceedings. 43: 3588-3592. 
4. Yenidunya O, Bircan HY, Altun D, et al. Anesthesia management with ultrasound-guided thoracic 
paravertebral block for donor nephrectomy: A prospective randomized study. J Clin Anes. 37:1-6. 
5. Hosgood S, Thiyagarajan U, Nicholson H, et al. Randomized clinical trial of transversus abdominis plane 
block versus placebo control in live-donor nephrectomy. Transplantation. 94: 520-525. 
6. Hutchins J, Kesha R, Dunn T, Hochhalter R. Ultrasound-guided subcostal transversus abdominis plane 
blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for post operoative pain control after 
laparoscopic hand-assisted donor nephrectomy: a prospective randomized observer-blinded study. 
Anaesthesia. 71: 930-937. 
7. Blanco R. “TAP block under ultrasound guidance: The description of a ‘non pops technique.’” Reg Anesth 
Pain Med. Vol 32, Supplement 1, 130. 
8. Ueshima H, Otake H, Lin J. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of 
Anatomy and Techniques. Biomed Res Int. 2017: ePub. Doi: 10.1155/2017/2752876. 
9. Blanco R, Ansari T, Riad W, Shetty N. Quadratus lumborum block versus transversus abdominis plane 
block for postoperative pain after Caesarean delivery: a randomized controlled trial. Reg Anesth Pain 
Med. 41:757-762 
10. Oksuz G, Bilal B, Gurkan Y, et al. Quadratus Lumborum Block Versus Transversus Adbominis Plane 
Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain 
Med. 42: 00-00. 
11. Waits S, Hilliard P, Sheetz K, Sung R, Englesbe M. Building the case for enhanced recovery protocols in 
living kidney donors. Transplantation. 99: 405-408. 

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12. Elsharkawy H, El-Boghadadly K, Kolli S, et al. Injectate spread following anterior sub-costal and posterior 
approaches to the quadratus lumborum block. Eur J Anaesthesiol.34:587-595. 
13. Murouchi T, Iwasaki S, Yamakage M. Quadratus lumborum block: Analgesic effects and chronological 
ropivacaine concentrations after laparoscopic surgery. Reg Anesth Pain Med. 41:146-150. 
14. Hawker GA, Mian S, Kendzerska T, et al. Measures of Adult Pain. Arthritis Care and Research. 
63(S11):S240-S252. 
15. Akaike, H. (1974), "A new look at the statistical model identification", IEEE Transactions on Automatic 
Control, 19 (6): 716–723, doi:10.1109/TAC.1974.1100705. 
16. Harrell, F. E. Jr.; Lee, K. L.; Califf, R. M.; Pryor, D. B.; Rosati, R. A. (1984). "Regression modelling 
strategies for improved prognostic prediction". Stat Med. 3 (2): 143–52. doi:10.1002/sim.4780030207 
 
G. CONSULTANTS__________________________________________________________________________ 
 
NA 
 
H. FACILITES AVAILABLE____________________________________________________________________ 
 
MUSC Hospital perioperative facilities, including preoperative holding, the operating room, and PACU/ recovery 
room. 
 
I. INVESTIGATOR BROCHURE ____________________________________________________ 
 
NA 
 
J. APPENDIX_______________________________________________________________________________ 
NA