Analgesia for Total Hip Arthroplasty With PENG Block (ATHAPENG) (ATHAPENG)
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69000
- Edouard Herriot hospital, hospices civils de Lyon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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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.
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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:
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NOL index is monitored in the operating room, during general anaesthesia while the surgical procedure is performed ( 60 to 120 minutes)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain scores and opioid consumption
Time Frame: Day 0, day 1, day 2 postoperatively
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
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