NCT05308420

PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

Pericapsular Nerve Group (PENG) Block vs Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: a Randomized Non-inferiority Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kresimir Oremus, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the impact of pericapsular nerve group (PENG) block to intrathecal morphine on postoperative analgesia, motor function and side effects in patients undergoing primary total hip arthroplasty under spinal anesthesia.

Detailed description

The study aims to confirm the non-inferiority of PENG block vs intrathecal morphine in patients undergoing total hip arthroplasty under spinal anesthesia. Non-inferiority will be assessed regarding maximum pain on a numerical rating scale at rest and during active hip flexion and regarding cumulative morphine consumption during 48 postoperative hours. Impact on quadriceps muscle motor function and side effects including pruritus, nausea and vomiting and hypotension will also be assessed.

Conditions

• Total Hip Arthroplasty
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Pericapsular nerve group (PENG) block	A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and 20ml 0.5% levobupivacaine with 2mg (0.5ml) dexamethasone injected (total volume of injectate 20.5ml) between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule
PROCEDURE	Spinal anesthesia	Spinal anesthesia will be performed at the level of the presumed interspace in-between the third and fourth lumbar vertebrae by introducing a 27 gauge pencil-point spinal needle and 15mg of levobupivacaine (3ml) injected intrathecally
DRUG	Intrathecal morphine	100 micrograms of preservative free morphine diluted to a volume of 0.5ml is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)
PROCEDURE	Sham PENG block	A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and a placebo solution consisting of 20.5ml 0.9%NaCl injected between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule
DRUG	Intrathecal placebo	0.5ml of placebo solution (0.9%NaCl) is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)

Timeline

• Start date: 2022-04-03
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2022-04-04
• Last updated: 2022-12-20

Locations

1 site across 1 country: Croatia