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Completed

NCT Number: NCT06954207

Analgesia for Total Hip Arthroplasty With PENG Block (ATHAPENG)

Analgesia for Total Hip Arthroplasty with PENG block (ATHAPENG)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Edouard Herriot hospital, hospices civils de Lyon

Lyon, 69000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventional. Data collection concerns routine procedures and monitoring devices

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ATHAPENG

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.