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

NCT03294109 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-000598
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score

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

  3 days post-op

Secondary Outcomes (5)

• Patient Satisfaction With Pain Management

  Day 1

• Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics

  Day 1

• Return of Bowel Function

  Day 5

• Participants Experiencing Complications Related to Surgery or Block

  Duration of inpatient stay, up to 5 days

• Opioid Use Dose/Day

  Day 3

Study Arms (2)

study

EXPERIMENTAL

liposomal bupivacain

Drug: Abdominal wall block with liposomal bupivicaine

control

NO INTERVENTION

no intervention

Interventions

Abdominal wall block with liposomal bupivicaine DRUG

Abdominal wall block with liposomal bupivicaine

Also known as: Exparel

study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing laparoscopic donor nephrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Connie Frank Kidney Transplant Center

Los Angeles, California, 90095, United States

Location

Related Publications (6)

• 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.

  PMID: 27891579 BACKGROUND

• 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.

  PMID: 28277325 BACKGROUND

• 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.

  PMID: 26225500 BACKGROUND

• 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.

  PMID: 27429253 BACKGROUND

• 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.

  PMID: 26771297 BACKGROUND

• 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.

  PMID: 34184312 DERIVED

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative; Patient Satisfaction; Sexual Behavior; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Siamak Rahman, MD
• Organization: university of Californiia

sirahman@mednet.ucla.edu

310 2678839

Study Officials

• Siamak Rahman, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Hans a Gritsch, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 26, 2017
• Study Start: January 1, 2018
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: January 10, 2022
• Results First Posted: November 5, 2021

Record last verified: 2021-12

Locations

US (1)