Analgesia for Total Hip Arthroplasty With PENG Block (ATHAPENG)

Completed

• Conditions: Total Hip Arthroplasty for Osteoarthritis

• Registration Number: NCT06954207
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Analgesia for Total Hip Arthroplasty with PENG block (ATHAPENG)

Detailed Description

Total hip arthroplasty (THA) for osteoarthritis is a commonly performed surgery worldwide. It is associated with significant pain, with median pain scores in the first 24 hours postoperatively exceeding 3 on the standardized numeric rating scale (NRS). Multimodal analgesia, including infusion of systemic analgesics and regional anesthesia through the Pericapsular Nerve Group Block (PENG block), has demonstrated efficacy in literature, when compared to other commonly used techniques such as the iliofascial block or surgical infiltration. However, analgesia provided by the PENG block appears to be incomplete, with a significant consumption of opioids in the postoperative period. The investigators hypothesis is that PENG block does not cover every hip sensitive territory involved during the surgical procedure.

The investigators conducted a single-center, observational, prospective study evaluating the antinociceptive effect of a PENG block performed preoperatively, at various surgical time points (incision, dislocation, femoral osteotomy, acetabular reaming, femoral reaming, femoral stem impaction, reduction, closure) by monitoring the Nociception Level Index (NOL index) during general anesthesia.

NOL index values (0 to 100) between 10 and 25 reflect nociception control, NOL index values exceeding 25 reflect excess of nociception, NOL index \< 10 reflects a potential excess of opioids infusion.

After surgery, pain scores (NRS), opioid consumption, and the presence of motor blockade within the first 48 hours postoperatively were also assessed.

The aim of the study is to determine the efficacy of PENG block combined to multimodal analgesia on intraoperative nociception and postoperative pain in patients undergoing total hip arthroplasty under general anaesthesia.

Study Timeline

• Study Start: 2024-06-25
• Primary Completion: 2024-06-25
• Study Completion: 2025-03-21
• Status Verified: 2025-04
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adult patients (> 18 years old)
• Undergoing primary hip arthroplasty for osteoarthritis
• Under general aneasthesia
• With PENG block

Exclusion Criteria

• Patient under 18 years old
• Severe cognitive impairment or patient under guardianship
• Pregnancy
• Allergy to local anaesthetics
• Chronic pain with daily opioid consumption
• Non sinusal cardiac rhythm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraoperative nociception monitored by Nociception Level Index (NOL index) : mean and percentage of variations throughout surgery and within each surgical time points	NOL index is monitored in the operating room, during general anaesthesia while the surgical procedure is performed ( 60 to 120 minutes)	To assess intra-operative nociception under general anaesthesia within each surgical time-points (incision, dislocation, femoral osteotomy, acetabular reaming, femoral reaming, femoral stem impaction, reduction, closure), NOL index is monitored continuously from anesthetic induction to end of surgery. Anaesthesiologist and nurse do not have access to the NOL screen monitor. Precise times of surgical time points are collected during surgery.; Datas are then exported in excel files and investigators analyse: * Mean, median and max NOL index values during whole surgery; * Mean, median and max NOL index values within each surgical time points; * NOL index: percentage of time above values of 25 during whole surgery; * NOL index : percentage of time above value of 25 within each surgical time points; * Percentage of NOL variation within each time points

Secondary Outcome Measures

Name	Time	Method
Pain scores and opioid consumption	Day 0, day 1, day 2 postoperatively	Pain scores evaluated by numeric rating scale (NRS, 0 to 10) are collected by nurses in charge of patients, in recovery room, and 6-12-24-48 hours postoperatively.; Total dose of opioid consumption on day 1 and day 2 post operatively are collected through medical files.

Trial Locations

Locations (1)

Edouard Herriot hospital, hospices civils de Lyon; 🇫🇷 Lyon, France