Comparing the Efficacy of Epidural and Quadratus Lumborum Analgesia After Open Nephrectomy Surgery

NCT03110081 | Completed DMC

• 1 other identifier: 15-1291
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural analgesia for pain control and opioid consumption through the third postoperative day in patients having open partial nephrectomy. Patients satisfying all inclusion and exclusion criteria will be randomized in a 1:1 ratio to either epidural catheter or QL catheter.

Conditions

Open Nephrectomy Surgery

Outcome Measures

Primary Outcomes (2)

• Total opioid consumption

  Total IV morphine-equivalent doses used, started postoperatively at the time of arrival to post anesthesia care unit until 72 hours after surgery.

  Arrival to post anesthesia care unit until 72 hours after surgery

• Postoperative pain

  Time-weighted average verbal rating scale for pain until 72 hours after operation as a time-weighted average, based on nursing assessments at four-hour intervals. The verbal rating scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst pain imaginable. Time-weighted average pain is defined as the sum of each time interval between two adjacent pain score measurements multiplied by the average of the two corresponding pain scores divided by the time interval between the first and last pain scores.

  Arrival to post anesthesia care unit until 72 hours after surgery

Secondary Outcomes (4)

• Patient Global Assessment

  Three days after surgery

• Doses of antiemetic medications administered

  Arrival to post anesthesia care unit until the third day after surgery

• Duration of postoperative hospitalization

  From the date of surgery to hospital discharge, assessed up to 12 months.

• Episodes of hypotension

  Arrival to post anesthesia care unit until the third day after surgery

Study Arms (2)

Quadratus lumborum block

EXPERIMENTAL

Quadratus lumborum (QL) block group will receive a single shot injection of 25 ml 0.25% bupivacaine pre-operatively, followed post-operatively by infusion of ropivacaine 0.2% continuously administered via the QL catheter for at least 48 hours.

Procedure: Quadratus lumborum block

Epidural analgesia

ACTIVE COMPARATOR

Midthoracic catheters will be inserted preoperatively. A bupivacaine 0.1% infusion will be started before the surgical incision, and continuously administered for at least 48 hr at an infusion rate of 5 ml/hr.

Procedure: Epidural analgesia

Interventions

Quadratus lumborum block PROCEDURE

Quadratus lumborum (QL) block for open partial nephrectomy.

Quadratus lumborum block

Epidural analgesia PROCEDURE

Epidural analgesia for open partial nephrectomy.

Epidural analgesia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults having for open unilateral partial nephrectomy surgery.

You may not qualify if:

• \. Pregnancy 2. Intolerance or allergy to opioids 3. Previous radical nephrectomy surgery/midline incision 4. Contraindication to epidural analgesia 5. Contraindications to QL block 6. Chronic pain characterized by: i.Opioids use for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine ii.Abdominal pain for more than 6 months, present most days of the week-

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Elsharkawy H, Ahuja S, Sessler DI, Maheshwari K, Mao G, Sakr Esa WA, Soliman LM, Ayad S, Khoshknabi D, Khan MZ, Raza S, DeGrande S, Turan A. Subcostal Anterior Quadratus Lumborum Block Versus Epidural Block for Analgesia in Open Nephrectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Apr 1;132(4):1138-1145. doi: 10.1213/ANE.0000000000005382.

  PMID: 33617181 DERIVED

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 12, 2017
• Study Start: May 1, 2018
• Primary Completion: September 14, 2020
• Study Completion: December 14, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

US (1)