Total Hip Arthroplasty for OsteoarthritisATHAPENGNCT06954207
Analgesia for Total Hip Arthroplasty With PENG Block (ATHAPENG)
An observational study of Total Hip Arthroplasty for Osteoarthritis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Analgesia for Total Hip Arthroplasty with PENG block (ATHAPENG) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty for Osteoarthritis
- What is being tested?
- Non interventional. Data collection concerns routine procedures and monitoring devices
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2024to 21 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing scheduled total hip arthroplasty for osteoarthritis under general anaesthesia with PENG block.
Who may be able to join
- Adult patients (> 18 years old)
- Undergoing primary hip arthroplasty for osteoarthritis
- Under general aneasthesia
- With PENG block
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Analgesia for Total Hip Arthroplasty with PENG block (ATHAPENG)
Read the 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.
- Being tested
- Non interventional. Data collection concerns routine procedures and monitoring devices
- Keywords
- PENG block analgesia, Total hip arthroplasty, NOL index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional. Data collection concerns routine procedures and monitoring devicesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Non interventional. Data collection concerns routine procedures and monitoring devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative nociception monitored by Nociception Level Index (NOL index) : mean and percentage of variations throughout surgery and within each surgical time points
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
Measured: NOL index is monitored in the operating room, during general anaesthesia while the surgical procedure is performed ( 60 to 120 minutes)
Secondary outcomes (1)
Pain scores and opioid consumption
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.
Measured: Day 0, day 1, day 2 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start25 Jun 2024
- Primary completion25 Jun 2024
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954207
- Sponsor's protocol ID
- 24-5166
- Other IDs
- 24-5166
- Acronym
- ATHAPENG
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia for Total Hip Arthroplasty With PENG Block (ATHAPENG)
- ClinicalTrials.gov ID
- NCT06954207
- Acronym / sponsor ID
- ATHAPENG / 24-5166
- Keywords
- PENG block analgesia, Total hip arthroplasty, NOL index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing total hip arthroplasty for osteoarthritis under general anaesthesia with PENG blo | – | Device: Non interventional. Data collection concerns routine procedures and monitoring devicesPatient undergoing total hip arthroplasty for osteoarthritis under general anaesthesia with PENG block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing scheduled total hip arthroplasty for osteoarthritis under general anaesthesia with PENG block.
Key inclusion criteria (4 listed)
- Adult patients (> 18 years old)
- Undergoing primary hip arthroplasty for osteoarthritis
- Under general aneasthesia
- With PENG block
Key exclusion criteria (6 listed)
- Patient under 18 years old
- Severe cognitive impairment or patient under guardianship
- Pregnancy
- Allergy to local anaesthetics
- Chronic pain with daily opioid consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventional. Data collection concerns routine procedures and monitoring devicesNon 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. | Device | Patient undergoing total hip arthroplasty for osteoarthritis under general anaesthesia with PENG blo |
Primary outcome
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
1 secondary outcome
Pain scores and opioid consumption
Time frame: Day 0, day 1, day 2 postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty for Osteoarthritis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.