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Clinical Trials in Switzerland / NCT06317870
Recruiting Not applicable

Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty

NCT06317870 · tracked via the Priya Life Science Switzerland tracker
Phase
Not applicable
Started
2024-09-10
Last updated
2024-08-22

Condition(s) studied

AnalgesiaHip ArthropathyPost Operative Pain

Investigational drug(s) / intervention(s)

Intrathecal morphinePericapsular nerve group block (PENG)

Intrathecal morphine: Spinal anesthesia will be performed as follows: patient will be placed in the lateral decubitus position on the non-operative side. Using sterile gloves red chlorhexidine 2% alcohol solution will be used for skin disinfection. The site will be secured with a sterile drape, and the L4-L5 lumbar space identified. After subcutaneous local infiltration with 1% lidocaine, a 25G Whitacre pencil point spinal needle will be used to access the intrathecal space with free flow of cerebrospinal fluid as confirmation. A mixture of 12.5 mg of isobaric bupivacaine and 100 mcg of morphine will be administered intrathecally. After the spinal anesthesia, the intrathecal morphine (ITM) group will receive a sham PENG block with the block needle inserted subcutaneously, the anesthesiologist using the same verbal block confirmation commands "aspirate, inject" but the needle withdrawn without injection. This will create the appearance of an identical cutaneous injection site to ensure patient blinding.

Pericapsular nerve group block (PENG): Spinal anesthesia with intrathecal injection of 12.5 mg of isobaric bupivacaine will be performed, followed by a PENG block. After skin disinfection, a low frequency curvilinear ultrasound probe (2-5 MHz 8870, BK ultrasound, Peabody Massachussets, US) with a sterile covering will be used to identify the anterior inferior iliac spine, the pubic eminence and the psoas tendon with its fascial plane. A 22 gauge 10cm block needle (Sonoplex® Pajunk, Geisingen, DE), will be used to enter the fascial plane and 20ml of 0.75% Ropivacain (Fresenius Kabi, Krienz CH) will be injected.

Study summary

The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery. The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain.

Participants will be randomised into two groups. Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic (isobaric bupivacaine) alone and a PENG block. Patients assigned to the intrathecal morphine (ITM) group will receive spinal anaesthesia with a mixture of local anaesthetic (isobaric bupivacaine) and morphine (100 mcg) and a sham PENG block to ensure patient blinding.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male and female patients * ASA (American Society of Anaesthesiologists) I-III * 18 years of age or older * Patients scheduled for elective primary hip arthroplasty * Able to give written conformed consent autonomously Exclusion Criteria: * Refusal or inability to give consent * Allergy to any of: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone * Bleeding diathesis * Neurological deficit of the operative side * Existing preoperative opioid use * Renal insufficiency (GFR\<30ml/min according to the Cockroft-Gault formula) * Hepatic insufficiency * Pregnant or lactating women

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Lausanne Lausanne Canton of Vaud Recruiting

More Centre Hospitalier Universitaire Vaudois trials in Switzerland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06317870 on ClinicalTrials.gov ↗ ← All trials in Switzerland