Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT03294109
• Collaborator: (none)
• Enrollment: 146
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.7
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

A blinded randomized control trial in living kidney donors. The study group will receive a liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general anesthesia. The following study variables will be collected postoperatively following arrival in the post-anesthesia care unit. Current and maximum intensity pain scores will be documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24 hours will be collected from the EHR and pain diary after discharge. Patient satisfaction will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing notes.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Analgesics, Opioid; Analgesics, Non-Narcotic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Patient Satisfaction; Return to Work; Activity, Sexual	Drug: Abdominal wall block with liposomal bupivicaine	Phase 4

Detailed Description

This is a blinded (patients are blinded and all the staff and the nurses who collect data are also blinded) randomized controlled trial in living kidney donors who have been approved by a multidisciplinary (nephrology, urology, psychiatry, and social work) team to proceed with donor nephrectomy. Patients will be approached to participate in the study only after they have agreed to kidney donation and have been informed of all of the associated risks. Participants are informed that they can withdraw from kidney donation at any time until they are in the operating room.

Patients meeting these criteria, who also consent to participate in the study, will be randomized (standard of care pain medication vs TQL block). The ratio of male to female patients in each arm will be equal because of the known increased risks for post-operative nausea/vomiting (PONV) in females. The study group will receive a liposomal bupivacaine TQL block after the induction of general anesthesia and liposomal bupivacaine transverse abdominis plane (TAP) block after closure of the midline fascia. All patients including the control group will have infiltration of the skin edges with bupivacaine. Control patients will have a TAP block with 5 cc of bupivacaine on both sides. A placebo 22g needle will be placed at the same site as the TQL block without injection. Intra-operative narcotics will be administered by the anesthesia team based on standard criteria. All participants will receive intravenous ketorolac and acetaminophen at the end of the procedure. Intravenous ketorolac will be continued for 24 hours while hospitalized. Post-operative pain management with intermittent parenteral and enteral narcotics as needed will be the same in both groups.

Liposomal bupivacaine block administration:

After induction of general anesthesia, surgical team will turn the patient to the lateral position (final position for surgery). After prep with and drape, investigators will place ultrasound probe in mid- posterior axillary line, just above iliac crest. The investigators will identify abdominal wall muscles including external oblique, internal oblique, transverse abdominis, and quadratus lumborum as well as thoracolumbar fascia with the help of ultrasound. Then, investigators will insert a 22g nerve block needle and advanced it under direct guidance of ultrasound until it is below the fascial covering of the quadratus lumborum muscle layer or its fascia which forms a continuous fascia compartment with thoracolumbar fascia. After aspiration to rule out intravascular location of the needle, investigators will be inject 20 mL of liposomal bupivacaine mixed with 10ml of normal saline under ultrasound guidance, to monitor spread of the injected fluid . The investigators will aspirate repeatedly every 5cc of local anesthetic. The investigators will remove the needle upon completion of the injection.

The following study variables will be collected postoperatively following arrival in the post-anesthesia care unit. Current and maximum intensity pain scores will be documented by nurses in EHR. Total opiate dose consumed every 24 hours will be collected from the EHR and pain diary after discharge. Patient satisfaction will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing notes

Complications will be documented by anesthesia pain service that will follow these patients while admitted.

Outpatient use of narcotics, pain assessment, bowel function, sexual function complications from the block or the donor surgery, and attitudes toward kidney donation will be evaluated with validated survey instruments. Please see the timeline for the collection of the data prior to and after kidney donation. The survey data will be collected using secure links to a REDCap server 3, 5, 10, 30, and 90 days after surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 146 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jun 24, 2020
• Actual Study Completion Date: Jun 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study liposomal bupivacain	Drug: Abdominal wall block with liposomal bupivicaine; Abdominal wall block with liposomal bupivicaine; Other Names: Exparel
No Intervention: control no intervention

Outcome Measures

Primary Outcome Measures

1. Change in Pain Score [3 days post-op]

   Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level

Secondary Outcome Measures

1. Patient Satisfaction With Pain Management [Day 1]

   The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey score on variable "Satisfaction with Pain Treatments." This is a scale ranging from 0-10, with 0 being extremely dissatisfied, a poor outcome, with pain treatment to 10 being extremely satisfied, a better outcome.

2. Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics [Day 1]

   Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.

3. Return of Bowel Function [Day 5]

   Bowl activity survey asked participants how big a problem the bowel function was after surgery, on a scale of 1 (no problem) to 5 (a big problem).

4. Participants Experiencing Complications Related to Surgery or Block [Duration of inpatient stay, up to 5 days]

   Number of participants that experienced a related complication in each arm

5. Opioid Use Dose/Day [Day 3]

   Milligram Morphine Equivalent /day

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients undergoing laparoscopic donor nephrectomy

Exclusion Criteria:

• Pregnancy

• Systemic or local infection at the potential block site.

• Allergy or hypersensitivity to the local anesthetic,

• Possible variations in surgical approach to donor nephrectomy other than what is defined in this protocol.

• Scarring or anatomic abnormality over the proposed injection site

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connie Frank Kidney Transplant Center	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

• Principal Investigator: Siamak Rahman, MD, University of California, Los Angeles
• Principal Investigator: Hans a Gritsch, MD, University of California, Los Angeles

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 20, 2020

More Information

Additional Information:

• Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty

Publications

• Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
• Børglum J, Gögenür I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378. Review.
• Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Børglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.
• Hansen CK, Dam M, Bendtsen TF, Børglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270.
• Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.

• Responsible Party: Siamak Rahman, MD, Clinical Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03294109
• Other Study ID Numbers: 17-000598
• First Posted: Sep 26, 2017
• Last Update Posted: Jan 10, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Siamak Rahman, MD, Clinical Professor, University of California, Los Angeles: TQL block, TAP block, donor nephrectomy, pain, patient satisfaction
• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine

Study Results

Participant Flow

Pre-assignment Detail	Prior to randomization, 146 patients signed consent. Of those 146, 137 completed the intake questionnaire, a requirement for the study. Of those 137, 103 were scheduled for surgery.

Arm/Group Title	Study	Control
Arm/Group Description	ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine:	ERAS Plus laparoscopic TAP block
Period Title: Overall Study
STARTED	46	57
Underwent Surgery	40	52
COMPLETED	40	52
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	Study	Control	Total
Arm/Group Description	ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	ERAS Plus laparoscopic TAP block	Total of all reporting groups
Overall Participants	40	52	92
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	37 92.5%	49 94.2%	86 93.5%
>=65 years	3 7.5%	3 5.8%	6 6.5%
Sex: Female, Male (Count of Participants)
Female	28 70%	36 69.2%	64 69.6%
Male	12 30%	16 30.8%	28 30.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	6 15%	6 11.5%	12 13%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 5%	0 0%	2 2.2%
White	27 67.5%	33 63.5%	60 65.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	5 12.5%	13 25%	18 19.6%
Region of Enrollment (participants) [Number]
United States	40 100%	52 100%	92 100%

Outcome Measures

1. Primary Outcome

Title	Change in Pain Score
Description	Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level
Time Frame	3 days post-op

Outcome Measure Data

Analysis Population Description

Participants who completed pain VAS survey on day 3

Arm/Group Title	Study	Control
Arm/Group Description	ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	ERAS Plus laparoscopic TAP block
Measure Participants	25	36
Mean (Standard Deviation) [score on a scale]	4.20 (1.94)	4.62 (1.74)

2. Secondary Outcome

Title	Patient Satisfaction With Pain Management
Description	The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey score on variable "Satisfaction with Pain Treatments." This is a scale ranging from 0-10, with 0 being extremely dissatisfied, a poor outcome, with pain treatment to 10 being extremely satisfied, a better outcome.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Patients who completed APS-POQ-R survey question "Satisfaction with Pain Treatments" on Day 1.

Arm/Group Title	Study	Control
Arm/Group Description	ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	ERAS Plus laparoscopic TAP block
Measure Participants	39	46
Mean (Standard Deviation) [score on a scale]	8.6 (1.9)	9.1 (1.2)

3. Secondary Outcome

Title	Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics
Description	Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study	Control
Arm/Group Description	ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	ERAS Plus laparoscopic TAP block
Measure Participants	40	52
pre-op Scopolamine patch	9 22.5%	11 21.2%
Rescue antiemetics in PACU	6 15%	8 15.4%

4. Secondary Outcome

Title	Return of Bowel Function
Description	Bowl activity survey asked participants how big a problem the bowel function was after surgery, on a scale of 1 (no problem) to 5 (a big problem).
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

Participants who completed the bowel activity survey on Day 5

Arm/Group Title	Study	Control
Arm/Group Description	ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine:	ERAS Plus laparoscopic TAP block
Measure Participants	31	38
Mean (Standard Deviation) [score on a scale]	1.9 (1)	1.9 (1.1)

5. Secondary Outcome

Title	Participants Experiencing Complications Related to Surgery or Block
Description	Number of participants that experienced a related complication in each arm
Time Frame	Duration of inpatient stay, up to 5 days

Outcome Measure Data

Analysis Population Description

All enrolled patients receiving surgery

Arm/Group Title	Study	Control
Arm/Group Description	ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	ERAS Plus laparoscopic TAP block
Measure Participants	42	50
Count of Participants [Participants]	5 12.5%	3 5.8%

6. Secondary Outcome

Title	Opioid Use Dose/Day
Description	Milligram Morphine Equivalent /day
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

Patients whom responded to survey on Day 3

Arm/Group Title	Study	Control
Arm/Group Description	ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	ERAS Plus laparoscopic TAP block
Measure Participants	25	29
0 MME	11 27.5%	9 17.3%
>0 - 5 MMe	6 15%	8 15.4%
>5 - 10 MME	3 7.5%	8 15.4%
>10-15 MME	3 7.5%	2 3.8%
>15-20 MME	2 5%	1 1.9%
>20 MME	0 0%	1 1.9%

Adverse Events

Time Frame	During hospitalization, up to 5 days
Adverse Event Reporting Description	Complications from surgery were collected as adverse events.
Arm/Group Title	Study		Control
Arm/Group Description	ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine		ERAS Plus laparoscopic TAP block
All Cause Mortality
	Study		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/50 (0%)
Serious Adverse Events
	Study		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Study		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/42 (11.9%)		3/50 (6%)
Blood and lymphatic system disorders
Hypotension	1/42 (2.4%)		0/50 (0%)
Injury, poisoning and procedural complications
Incisional hematoma	0/42 (0%)		1/50 (2%)
Wound infection	1/42 (2.4%)		0/50 (0%)
Contralateral flank pain and acute kidney injury	1/42 (2.4%)		0/50 (0%)
Wound seroma	1/42 (2.4%)		0/50 (0%)
Renal and urinary disorders
Urinary Retention	1/42 (2.4%)		1/50 (2%)
Respiratory, thoracic and mediastinal disorders
Pleural Effusion requiring aspiration	0/42 (0%)		1/50 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.