The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay.

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: PENG block; Procedure: Placebo

• Registration Number: NCT05056675
• Lead Sponsor: Hôpital Fribourgeois

Brief Summary

Effective postoperative pain management in elective hip surgery is crucial for the patients well-being, rapid mobilisation and potential reduction of length of stay. In addition to standard intravenous pain medication, anaesthetic blocks are reportedly effective. Recently, the PENG block, a pericapsular pain block without impairment of the motor function has been introduced in literature and performed at the investigator's hospital (HFR Fribourg, Switzerland) for total hip arthroplasty and surgical hip dislocation - the two most commonly performed elective hip surgeries.

As high-quality evidence on the effectiveness of this novel block is lacking, the investigator's objective is to evaluate the effectiveness of (1) patient-reported pain reduction, (2) total consumption of postoperative morphine, and the length of stay at the hospital.

Detailed Description

Forty patients undergoing total hip arthroplasty and 40 patients undergoing surgical hip dislocation will be enrolled in a prospective, double-blind, controlled trial performed at the investigator's hospital.

This study will be the first prospective study evaluating the potential of this pain block in elective hip surgery potentially affecting both patients' postoperative well-being and optimizing costs of the hospital by reducing length of stay.

Study Timeline

• Study First Submitted: 2021-08-28
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-09-24
• Study Start: 2022-06-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Anterior total hip arthroplasty for hip osteoarthritis
• Surgical hip dislocation for femoro-acetabular impingement (type cam-/pincer)
• Age 16-85 years
• American Society of Anesthesiologists (ASA) physical status 1 to 3

Exclusion Criteria

• Patient refusal/no informed consent
• Inability to give informed consent
• Lateral approach for total hip arthroplasty
• Bilateral procedure
• Additional osteotomies of the femur and/or acetabulum
• Previous hip & pelvis surgery
• Chronic opioid users
• Known allergy or intolerance to medications used in the trial (local anesthetic, opioid)
• Infection at the injection site
• Body mass index > 40kg/m2
• Spinal anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENG block for anterior total hip arthroplasty or surgical hip dislocation	PENG block	All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of 0.5% ropivacaine iv is injected.
Placebo for anterior total hip arthroplasty or surgical hip dislocation	Placebo	All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of NaCL 0.9% is injected.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)	Reduction of postoperative pain in the first 24 hours after surgery	Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 10. A higher score indicates greater pain intensity

Secondary Outcome Measures

Name	Time	Method
Total morphine consumption (morphine equivalent dose)	Total consumption of postoperative morphine in the first 24 hours after surgery	Total morphine consumption in morphine equivalent dose (MED) in the fist 24 hours after surgery.
Length of stay (days)	Length of stay at the hospital (in days) from the day of the surgery (day 0) to the day of discharge, up to a maximum of 7 postoperative days	The length of hospital stay is measured in days, from the day of surgery (day 0) to the patient's discharge from the hospital. Discharge occurs up to a maximum of 7 days after surgery when the 3 following criteria are met: the scar must be dry, the pain must no longer require morphine and the patient must be able to walk with crutches

Trial Locations

Locations (1)

HFR Fribourg - Hôpital cantonal; 🇨🇭 Fribourg, Switzerland