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

March 12, 2024 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty: a Double Blind, Non-inferiority Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this double-blind, non-inferiority study is to compare the analgesic effect of a PENG block with intrathecal morphine in patients scheduled for total hip arthroplasty. Postoperative morphine consumption and pain scores, morphine-related adverse effects and functional parameters will be compared between two groups.

The investigators believe that PENG block provides postoperative analgesia equivalent to intrathecal morphine. The research team plans to enrol 80 patients and randomise them to two groups - pericapsular nerve block (PENG) or intrathecal morphine (ITM). After written informed consent, patients will be allocated to one of the two groups according to a computer-generated randomisation list. The PENG group will receive central spinal anaesthesia with 12.5 mg isobaric bupivacaine and PENG block with 20 cc of 0.75% ropivacaine. ITM groups will receive central spinal anaesthesia with 12.5 mg isobaric bupivacaine and 100 mcg morphine followed by a sham PENG block.

During the surgery, 0.15 mg/kg of dexamethasone iv, 1g acetaminophen iv, 30mg ketorolac iv and 40mg/kg magnesium iv will be administered for post operative analgesia.

In the post-operative care unit, pain management will be provided with as needed with 2mg of IV morphine at ten minute intervals for pain scores >3. Once spinal motor block has ceded, the patients will be transferred to the surgical ward with a morphine patient controlled analgesia (PCA) pump. The pump parameters will allow 2 mg boluses of morphine with a 10-minute lockout and a maximum dose of 40 mg in 4 hours. Basal analgesia will be provided with paracetamol (1g/6h) and ibuprofen (400mg/8h). Ondansetron (4mg IV) will be provided in case of nausea or vomiting. A research assistant will conduct post operative visits at 2h, 1 day and 2 days post-operatively to record research data. Functional testing will be performed at day 1 and 2 by physiotherapy personnel.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • University Hospital of Lausanne
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PENG group
Pericapsular nerve group block
Procedure: Pericapsular nerve group block (PENG)

A PENG block will be performed prior to spinal anesthesia. 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.

Spinal anesthesia with intrathecal injection of 12.5 mg of isobaric bupivacaine will then be performed.
Active Comparator: ITM group
intrathecal morphine injection
Procedure: Intrathecal morphine

Prior to 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.

Spinal anesthesia will then 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative postoperative morphine consumption at day 1
Time Frame: 24 hours postoperatively
total consumption in mg
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption in the recovery room
Time Frame: from admission till discharge from the recovery room, up to 2 hours
consumption in mg
from admission till discharge from the recovery room, up to 2 hours
PCA administered morphine consumption at day 2
Time Frame: at day 2 postoperatively
consumption in mg administered by PCA
at day 2 postoperatively
rest and dynamic pain scores
Time Frame: at 2 hours, day 1 and day 2 postoperatively
Visual Analogue Scale(VAS), 0-10
at 2 hours, day 1 and day 2 postoperatively
Incidence of postoperative nausea and vomiting
Time Frame: at 2 hours, day 1 and day 2 postoperatively
Presence of nausea or vomiting in the postoperative period
at 2 hours, day 1 and day 2 postoperatively
Incidence of pruritus
Time Frame: at 2 hours, day 1 and day 2 postoperatively
Presence of pruritus in the postoperative period
at 2 hours, day 1 and day 2 postoperatively
Incidence of urinary retention requiring bladder catheterisation
Time Frame: from surgery till day 2 postoperatively
Urinary retention requiring catheterisation
from surgery till day 2 postoperatively
Duration of analgesia
Time Frame: from the time the study procedure is performed up to 36 hours after surgery
Time between study procedure and the first dose of iv morphine
from the time the study procedure is performed up to 36 hours after surgery
operated limb quadriceps strength
Time Frame: at day 1 and day 2 postoperatively
Medical Research Council Manual Muscle Testing scale, 0-5
at day 1 and day 2 postoperatively
Walking test
Time Frame: at day 1 and 2 postoperatively
maximum distance travelled (meters)
at day 1 and 2 postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUV_PENGIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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