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PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

NCT05308420 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-20

No results posted yet for this study

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.

Conditions

  • Total Hip Arthroplasty
  • Postoperative Pain

Interventions

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)

Sponsors & Collaborators

  • Kresimir Oremus, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-03
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05308420 on ClinicalTrials.gov