PENG Block Plus Local Infiltration Compared to PENG Block Alone in Hip Surgery

August 19, 2023 updated by: Suez Canal University

Evaluation of Analgesic Effect of Added Local Infiltration to Pericapsular Nerve Group Block in Traumatic Hip Surgery

Summary:

Pain control after hip surgery is quite important for patients' recovery. Many regional techniques are available with the focus on motor sparing block to speed patient recovery.

The investigators will compare pericapsular nerve group (PENG) block in addition to local skin infiltration to PENG block alone. The study population will be included for patient traumatic hip surgery. The study population will be divided into group. First group will receive PENG block and local anaesthetics infiltration and second group will receive PENG block.

Our primary outcome is to compare numeric rating scale (NRS) between studied groups, and morphine requirements in the first 24 hours as a secondary outcome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim of the study:

The aim of the study is to improve quality of patient's post-operative recovery after hip surgery.

Study objectives:

To compare Patient numeric rating scale (NRS) scores after hip surgery for patients receiving PENG block and local skin infiltration

Study question:

Will PENG block and local infiltration provide significant analgesia for hip surgery than PENG block alone?

Null Hypothesis:

Local infiltration addition to PENG block will not provide significant analgesia to PENG block alone.

Alternative hypothesis:

Local infiltration addition to PENG block will provide significant superior analgesia to PENG alone.

Study Design:

Single blinded randomized clinical trial. Ethical approval will be obtained from Suez Canal University. Patients' enrolment will be obtained preoperatively. Patients' demographic data will be recorded (age, weight, BMI, and gender).

An informed consent will be obtained during enrolment explaining the aim of the study and complication of the techniques. Patient will have the right to withdraw from the study at any time.

Patients will be randomly allocated to either of the studied group through the following method:

Randomization of the patients meeting the inclusion criteria will be achieved by a computer-generated random sequence, and this sequence will be concealed in sealed numbered envelopes, labelled Group A (study group) carry the label Group B (control group).

Methods:

Group A (study group) will receive both PENG block and local infiltration at the end of the surgery. Group B (control group) will receive PENG block without local infiltration.

Spinal anaesthesia will be administered to the patient using 10-12.5 mg heavy 0.5% bupivacaine at L3-L5 lumbar spine using 25 G spinal needle.

If spinal anaesthesia is contraindicated or failed, patients will have general anaesthetics.

General anaesthesia will be induced with 1-2 mcg/kg fentanyl, propofol 1-2 mg/kg, and appropriate muscle relaxant.

Block will be administered for trauma patients PENG block will be administered as following:

A curvilinear US sound probe will be placed in a transverse plane over anterior superior iliac spine and rotated 45 degrees anticlockwise till identifying femoral vessels, iliopubic eminence, iliopsoas muscle tendon in the view. A 100 mm echogenic needles (SonoPlex STIM, Germany) will be advanced from lateral to medial and injecting 20 ml of 0.25% bupivacaine below the psoas tendon.

A 20 ml of 0.25% bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery.

Pain management:

All patients will receive 1g of paracetamol, 30 mg Ketorolac, and 8 mg Dexamethasone after spinal anaesthesia.

Postoperatively 1g of paracetamol four times a day, ketorolac 30 mg twice a day for 48 hours. Intravenous morphine 2 mg every 10 minutes will be given to the patient if NRS score ≥ 4 till pain is controlled as rescue analgesics.

Morphine requirement will be assessed in recovery and then every 6 hours, in the first 24 hours after surgery. If the pain score > 4, patient will get 2 mg IV morphine. Pain will be reassessed after 10 minutes for further analgesia requirement.

Study Type

Interventional

Enrollment (Estimated)

122

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 Contact Backup

Study Locations

  • Egypt
      • Ismailia, Egypt
        • Recruiting
        • Suez Canal University Hospital
        • Contact:
          • Eslam Albayadi
          • Phone Number: +201223666764

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. American Society of Anaesthesiology (ASA) 1-3
  2. Traumatic hip surgeries (total hip arthroplasty, hemiarthroplasty, Dynamic hip screw).

Exclusion Criteria:

  1. Patient with cognitive impairment.
  2. Patient weight < 50 kg.
  3. Allergy to medications used.
  4. Chronic kidney disease. (serum creatinine > 2.5 mg/dl).

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pericapsular Nerve Group Block plus local infiltration

Group A (study group) will receive both PENG block and local infiltration at the end of the surgery.

Spinal anaesthesia will be administered to the patient using 7.5-12.5 mg heavy 0.5% bupivacaine at L3-L5 lumbar spine using 25 G spinal needle.

If spinal anaesthesia is contraindicated or failed, patients will have general anaesthetics.

General anaesthesia will be induced with 2-3 mcg/kg fentanyl, Propofol 1-2 mg/kg titrated to effect, and muscle relaxant if required.

PENG block will be administered according to the description by injecting 20 ml of 0.25% bupivacaine below the psoas tendon.

A 20 ml of 0.25% bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery.
Other: PENG block with or without local anaesthetic infiltration
As mentioned.
Active Comparator: Pericapsular Nerve Group Block
In Group B, only PENG block will be administered in this arm
Other: PENG block with or without local anaesthetic infiltration
As mentioned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: 24 hours
The difference in patient numeric rating scale (NRS). 11 points scale, where 0 means no pain and 10 is worst possible pain. The higher pain scores means worse outcome between both groups.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine requirement
Time Frame: 24 hours
Postoperative morphine requirement
24 hours

Collaborators and Investigators

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

Sponsor

Suez Canal University

Investigators

  • Principal Investigator: Eslam Albayadi, Suez Canal University, Ring Road, Ismailia, Egypt

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 (Actual)

July 18, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5177

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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