Quadratus Lumborum Block Versus Transversus Abdominus Plane Block for Pain Management After Donor Nephrectomy

NCT03476850 | Completed Results DMC

• 1 other identifier: Pro00073925
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients.

Conditions

Kidney Donor

Outcome Measures

Primary Outcomes (1)

• Average Pain Score

  NRS patient reported (number rated pain score, 0=no pain - 10=highest pain) over the first 24 hours post operative.

  24 hours post operative

Secondary Outcomes (5)

• Total Cumulative Opioids

  72 hours

• Number of Participants With Nausea or Emesis Requiring Antiemetic Medication

  24 hours

• Number of Participants With Block Related Complications

  24 hours

• Length of Stay in Post Anesthesia Care Unit (PACU)

  24 hours

• Length of Hospital Stay

  3 days

Study Arms (2)

QL Block

ACTIVE COMPARATOR

Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.

Procedure: QL Block

TAP Block

ACTIVE COMPARATOR

Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.

Procedure: TAP Block

Interventions

QL Block PROCEDURE

Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.

QL Block

TAP Block PROCEDURE

Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.

TAP Block

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 assisted donor nephrectomy
• Patients that have elected to have a nerve block
• years of age or older
• Patients of ASA status I - III

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Eric Bolin, MD
• Organization: Medical University of South Carolina

bolin@musc.edu

8437921869

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 26, 2018
• Study Start: February 19, 2018
• Primary Completion: May 22, 2019
• Study Completion: May 22, 2019
• Last Updated: July 14, 2020
• Results First Posted: July 14, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)