Analgesia for Total Hip Arthroplasty With PENG Block (ATHAPENG) (ATHAPENG)

April 24, 2025 updated by: Hospices Civils de Lyon
Analgesia for Total Hip Arthroplasty with PENG block (ATHAPENG)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

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

Study Locations

  • France
      • Lyon, France, 69000
        • Edouard Herriot hospital, hospices civils de Lyon

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

Sampling Method

Probability Sample

Study Population

Adult patients undergoing scheduled total hip arthroplasty for osteoarthritis under general anaesthesia with PENG block.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient undergoing total hip arthroplasty for osteoarthritis under general anaesthesia with PENG blo
Patient undergoing total hip arthroplasty for osteoarthritis under general anaesthesia with PENG block
Device: Non interventional. Data collection concerns routine procedures and monitoring devices
Non interventional. Physiological parameters under general anesthesia are collected (arterial pressure, heart rhythm, bispectral index, NOL index, temperature, total dose of remifentanil infusion, analgesic drugs infusions). After surgery, pain scores (NRS), motor function and time to ambulation are also collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative nociception monitored by Nociception Level Index (NOL index) : mean and percentage of variations throughout surgery and within each surgical time points
Time Frame: 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
NOL index is monitored in the operating room, during general anaesthesia while the surgical procedure is performed ( 60 to 120 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores and opioid consumption
Time Frame: 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.
Day 0, day 1, day 2 postoperatively

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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)

June 25, 2024

Primary Completion (Actual)

June 25, 2024

Study Completion (Actual)

March 21, 2025

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5166 (Other Identifier: HCL)

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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