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

Primary Purpose

Pain, Postoperative, Analgesics, Opioid, Analgesics, Non-Narcotic

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Abdominal wall block with liposomal bupivicaine
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring TQL block, TAP block, donor nephrectomy, pain, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Connie Frank Kidney Transplant Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

study

control

Arm Description

liposomal bupivacain

no intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Satisfaction With Pain Management
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.
Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics
Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.
Return of Bowel Function
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).
Participants Experiencing Complications Related to Surgery or Block
Number of participants that experienced a related complication in each arm
Opioid Use Dose/Day
Milligram Morphine Equivalent /day

Full Information

First Posted
September 18, 2017
Last Updated
December 20, 2021
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03294109
Brief Title
Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy
Official Title
Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
June 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Analgesics, Opioid, Analgesics, Non-Narcotic, Physiological Effects of Drugs, Peripheral Nervous System Agents, Patient Satisfaction, Return to Work, Activity, Sexual
Keywords
TQL block, TAP block, donor nephrectomy, pain, patient satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study
Arm Type
Experimental
Arm Description
liposomal bupivacain
Arm Title
control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Drug
Intervention Name(s)
Abdominal wall block with liposomal bupivicaine
Other Intervention Name(s)
Exparel
Intervention Description
Abdominal wall block with liposomal bupivicaine
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
Title
Opioid Use Dose/Day
Description
Milligram Morphine Equivalent /day
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siamak Rahman, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans a Gritsch, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connie Frank Kidney Transplant Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27891579
Citation
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.
Results Reference
background
PubMed Identifier
28277325
Citation
Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum 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.
Results Reference
background
PubMed Identifier
26225500
Citation
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.
Results Reference
background
PubMed Identifier
27429253
Citation
Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
Results Reference
background
PubMed Identifier
26771297
Citation
Hansen CK, Dam M, Bendtsen TF, Borglum 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. No abstract available.
Results Reference
background
PubMed Identifier
34184312
Citation
Gritsch HA, Osbun N, Grogan T, Fero KE, Partownavid P, Stockman J, Sadoughi N, Park E, Miller E, Blumberg J, McDonald M, Cowan N, Shah N, Rahman S. Randomized controlled trial of a quadratus lumborum block with liposomal bupivacaine for postoperative analgesia in laparoscopic donor nephrectomy. Clin Transplant. 2021 Sep;35(9):e14403. doi: 10.1111/ctr.14403. Epub 2021 Jul 14.
Results Reference
derived
Links:
URL
http://dx.doi.org/10.1016/j.jclinane.2015.05.006
Description
Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty

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

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