Ultrasound-guided PENG Block in Total Hip Replacement

NCT04984109 | Completed

• 1 other identifier: 34582/3/21
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

• This randomized controlled study will be carried out on 60 adult patients undergoing primary total hip replacement in Tanta University Hospitals. All Patients will receive spinal anesthesia with either sham or real US-guided PENG block.
• The primary outcome will be the time to first request for rescue analgesia. The secondary outcome will be the postoperative Numeric Rating Scale (NRS) score and the total morphine consumption (rescue analgesia) in the first 24 h postoperatively.

Conditions

Pain, Postoperative; Opioid Overdose

Keywords

Hip arthroplasty; Pericapsular nerve block; Pain

Outcome Measures

Primary Outcomes (1)

• Time for first request of rescue analgesia

  Time to the first call for morphine rescue analgesia.

  The first day after surgery

Secondary Outcomes (1)

• Postoperative morphine consumption

  The first day after surgery

Study Arms (2)

Control group

SHAM COMPARATOR

Patients will receive preoperative US-guided will receive sham PENG with an injection of just 1mL saline.

Procedure: Sham PENG block

PENG Group

EXPERIMENTAL

Patients will receive preoperative US-guided will receive real PENG with an injection of 20mL of bupivacaine 0.25%+ 0.2mg/mL dexamethasone.

Procedure: Real PENG block

Interventions

Sham PENG block PROCEDURE

The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 1 mL of normal saline.

Control group

Real PENG block PROCEDURE

The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/mL dexamethasone that will be injected in 5 ml aliquots after negative aspiration.

PENG Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, aged 21-75 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Scheduled to undergo unilateral total hip replacement surgery.

You may not qualify if:

• Patient refusal.
• Known hypersensitivity to local anesthetics.
• Body mass index \> 35 kg /m2.
• Uncooperative or psychiatric patients.
• Infection at the injection site.
• Coagulation disorder.
• Major cardiac, renal, or hepatic diseases

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Algharbia, 31511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Opiate Overdose; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• Sameh Abdelkhalik, M.D

  Assistant Professor of Anesthesia and Intensive Care, Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Sham ESP block will be administrated in the control group * Measurements will be obtained by anesthetists not participating in the study and blinded to its group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective study

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: July 30, 2021
• Study Start: August 2, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: \- Within 6 months from acceptance of publication
• Access Criteria: samehabdelkhalik1982@gmail.com

Locations

EG (1)