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

Not Applicable

Completed

• Conditions: Open Nephrectomy Surgery
• Interventions: Procedure: Quadratus lumborum block; Procedure: Epidural analgesia

• Registration Number: NCT03110081
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

QL blocks with a single shot and catheters infusions may be an alternative to epidural analgesia. However, the relative efficacy, safety, and cost of the two approaches remain unclear.

Epidural analgesia is frequently used as a component of multimodal analgesia for thoracic and abdominal surgery. QL block has been introduced recently as a component of multimodal analgesia for lower thoracic and abdominal surgery. In general, insertion of QL catheter is easier and safer than insertion of epidural catheters. QL catheter management is also less complicated than epidural analgesia (fewer catheter displacements and less hemodynamic compromise) and decreases the level of complexity in postoperative care. Our hypothesis is that the subcostal QL approach with a continuous catheter is non-inferior to epidural analgesia for pain control and opioid consumption in patients having open partial nephrectomy procedure.

Study Timeline

• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2018-05-01
• Primary Completion: 2020-09-14
• Study Completion: 2020-12-14
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Adults having for open unilateral partial nephrectomy surgery.

Exclusion Criteria

1. 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-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus lumborum block	Quadratus lumborum block	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.
Epidural analgesia	Epidural analgesia	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.

Primary Outcome Measures

Name	Time	Method
Total opioid consumption	Arrival to post anesthesia care unit until 72 hours after surgery	Total IV morphine-equivalent doses used, started postoperatively at the time of arrival to post anesthesia care unit until 72 hours after surgery.
Postoperative pain	Arrival to post anesthesia care unit until 72 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Duration of postoperative hospitalization	From the date of surgery to hospital discharge, assessed up to 12 months.	Duration of postoperative hospitalization
Patient Global Assessment	Three days after surgery	Patient global assessment of pain control is measured on an ordinal scale by the patient. Patients can rate their pain control as poor, fair, good, or excellent.
Doses of antiemetic medications administered	Arrival to post anesthesia care unit until the third day after surgery	Count of the number of antiemetic medications administered.
Episodes of hypotension	Arrival to post anesthesia care unit until the third day after surgery	Number of episodes of hypotension during hospital stay, defined by MAP less than 65 mmHg requiring intervention.

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States