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

NeuroTherapia, Inc.

Status: Completed

Conditions: Open Nephrectomy Surgery

Treatments: Procedure: Quadratus lumborum block; Procedure: Epidural analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03110081

15-1291

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Volunteers: No Healthy Volunteers

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-

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups

Quadratus lumborum block

Experimental group

Description:

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.

Treatment:

Procedure: Quadratus lumborum block

Epidural analgesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Epidural analgesia