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

NCT ID: NCT03110081

Last Updated: 2021-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-12-14

Brief Summary

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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

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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.

Conditions

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Open Nephrectomy Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Quadratus lumborum block

Intervention Type PROCEDURE

Quadratus lumborum (QL) block for open partial nephrectomy.

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.

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type PROCEDURE

Epidural analgesia for open partial nephrectomy.

Interventions

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Quadratus lumborum block

Quadratus lumborum (QL) block for open partial nephrectomy.

Intervention Type PROCEDURE

Epidural analgesia

Epidural analgesia for open partial nephrectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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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-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33617181 (View on PubMed)

Other Identifiers

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15-1291

Identifier Type: -

Identifier Source: org_study_id

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