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

ConditionsAnalgesiaHip ArthropathyPost Operative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Vaudois

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients

ASA (American Society of Anaesthesiologists) I-III

18 years of age or older

Patients scheduled for elective primary hip arthroplasty

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal morphine

    Procedure/Surgery

    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)

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: PENG groupExperimental treatment 1 intervention
Group B: ITM groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative postoperative morphine consumption at day 1

total consumption in mg

Time frame
24 hours postoperatively

Secondary outcomes

1

Morphine consumption in the recovery room

consumption in mg

Time frame
from admission till discharge from the recovery room, up to 2 hours
2

PCA administered morphine consumption at day 2

consumption in mg administered by PCA

Time frame
at day 2 postoperatively
3

rest and dynamic pain scores

Visual Analogue Scale(VAS), 0-10

Time frame
at 2 hours, day 1 and day 2 postoperatively
4

Incidence of postoperative nausea and vomiting

Presence of nausea or vomiting in the postoperative period

Time frame
at 2 hours, day 1 and day 2 postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire Vaudois

Lead sponsor

Source ClinicalTrials.gov
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