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Analgesia for Total Hip Arthroplasty With PENG Block (ATHAPENG)

Analgesia for Total Hip Arthroplasty With PENG Block (ATHAPENG)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06954207
Acronym
ATHAPENG
Enrollment
70
Registered
2025-05-01
Start date
2024-06-25
Completion date
2025-03-21
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Arthroplasty for Osteoarthritis

Keywords

PENG block analgesia, Total hip arthroplasty, NOL index

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.

Interventions

DEVICENon 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative nociception monitored by Nociception Level Index (NOL index) : mean and percentage of variations throughout surgery and within each surgical time pointsNOL 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

MeasureTime frameDescription
Pain scores and opioid consumptionDay 0, day 1, day 2 postoperativelyPain 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026