Postoperative PainTHAPengNCT04650100
Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery
A study testing ultrasound-guided PENG bloc realized before surgery in people with Postoperative Pain, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The intra- and peri-articular infiltration of local anaesthetics realized at the end of total hip arthroplasty surgeries is an effective analgesic technique, but it can be insufficient to manage the possibly intense postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ultrasound-guided PENG bloc realized before surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2020to 8 Jul 2021
- Phase
- Interventional
- 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
Who may be able to join
- Scheduled for total hip arthroplasty surgery under general anaesthesia
- Affiliated of a social security scheme
- Having signed the written informed consent
Who cannot join
- Total hip arthroplasty revision surgery
- Refusal of the patient to participate
- Existence of major spontaneous or acquired haemostasis disorders
- Infection at the puncture site
- Allergy to local anaesthetics
- Pregnancy or breast-feeding
- Patients under the protection of adults (guardianship, curatorship or protection of justice)
- Patients whose cognitive state does not allow assessment by the scales used.
Trial locations and contacts
1 site in 1 country.
About this study
The intra- and peri-articular infiltration of local anaesthetics realized at the end of total hip arthroplasty surgeries is an effective analgesic technique, but it can be insufficient to manage the possibly intense postoperative pain. Regional anaesthesia (RA) like the recently described pericapsular nerve group (PENG) block could provide additional analgesic benefit in this setting.
Investigators main objective is to demonstrate the analgesic benefits (postoperative pain score and morphine consumption) of the PENG block when added to intra- and peri-articular infiltration of local anaesthetic following total hip arthroplasty. Investigators make the assumption that i) the PENG bloc could reduce the postoperative 24 first hours morphine consumption by 30%, ii) the PENG block could spare the motor function of the quadriceps and adductor muscles, and iii) the PENG bloc could be well tolerated allowing a high level of patient satisfaction.
Read the detailed description
A recent study has revealed a region of pericapsular terminal branches of the femoral nerve and the obturator nerve accessible to ultrasound-guided regional anaesthesia. This technique, also called the PENG block, has recently been described with a substantial benefit on pain at rest and induced by mobilization in cases series of patients undergoing hip fracture surgery. To investigators knowledge, no randomized data concerning the analgesic efficacy of the PENG block has been published in the setting of elective total hip arthroplasty.
The PENG block would allow a significant analgesic contribution when added to intra- and peri-articular infiltration of local anaesthetics while being well tolerated with few undesirable effects. Moreover, the PENG block could spare the motor function of the quadriceps and adductor muscles allowing enhanced recovery after surgery
- Conditions
- Postoperative Pain
- Being tested
- ultrasound-guided PENG bloc realized before surgery
- Keywords
- Total hip arthroplasty, PENG bloc, local anaesthetics infiltration, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided PENG bloc realized before surgeryProcedure or surgery
ultrasound-guided PENG block realized before surgery. The PENG block, described by Giron-Arebgi is made in the supine position. The ultrasound probe used is a 5 MHz high frequency linear probe placed parallel to the line delimited by the anterior-inferior iliac spine (lateral) and the pubis (medial). The needle used is an 80 mm, 22G, needle inserted in the ultrasound plane. The slow and fractioned injection of 20 ml of Ropivacaine 4.75 mg/ml is performed in the fascia between the psoas tendon and the iliopubic eminence under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| PENG group | Experimental | For the PENG group, the ultrasound-guided PENG block (20 ml of Ropivacaine 4.75 mg/ml) is performed before the surgery. Receives: Procedure: ultrasound-guided PENG bloc realized before surgery |
| Control group | No intervention | No additional intervention, only standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated postoperative morphine consumption 24 hours after surgery
calcul of Cumulated postoperative morphine consumption 24 hours after surgery
Measured: 24 hours
Secondary outcomes (17)
Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)
Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)
Measured: Hour 1
Cumulated postoperative morphine consumption 48 hours after surgery
Cumulated postoperative morphine consumption 48 hours after surgery
Measured: Hour 48
Evaluation of pain in the PACU
Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) in the PACU
Measured: Hour 1
Evaluation of pain 24 hours after surgery
Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) 24 hours after surgery
Measured: Hour 24
Evaluation of pain 48 hours after surgery
Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) 48 hours after surgery
Measured: Hour 48
Evaluation of the pain potentially induced by the realization of the PENG block
Evaluation of the pain potentially induced by the realization of the PENG block with Likert scale from 1 to 5, 1 is for no pain, 5 is for the worse pain
Measured: Hour 0
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Measured: Hour 0
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Measured: Hour 1
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Measured: Hour 24
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Measured: Hour 48
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Measured: Hour 0
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Measured: Hour 1
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Measured: Hour 24
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Measured: Hour 48
Evaluation of the patients' satisfaction
Evaluation of the patients' satisfaction by the EVAN-LR score realized 24 hours after surgery. EVAN-LR is a scale assessing perioperative patient's satisfaction with Loco Regional anaesthesia
Measured: Hour 24
Evaluation of the adductor muscles weakness
Evaluation of the adductor muscles weakness by a thigh adduction test performed 24 hours after surgery
Measured: Hour 24
Evaluation of the quadricipital muscles weakness
Evaluation of the quadricipital muscles weakness by a Timed to Up and Go Test performed 24 hours after surgery
Measured: Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start14 Dec 2020
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FERRE Fabrice, PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650100
- Sponsor's protocol ID
- RC31/20/0227
- Other IDs
- 2020-A01887-32
- Acronym
- THAPeng
- Status last verified
- Jul 2024
- First submitted
- 24 Nov 2020
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferre F, Rey J, Bosch L, Menut R, Ferrier A, Ba C, Halimi C, Collinson I, Tissot B, Labaste F, Reina N, Minville V. Pericapsular nerve group (PENG) block combined with local infiltration analgesia is not superior to local infiltration analgesia for the management of postoperative pain after primary elective total hip arthroplasty: A prospective, randomized, controlled, single-blind trial. Heliyon. 2024 Jun 27;10(13):e33766. doi: 10.1016/j.heliyon.2024.e33766. eCollection 2024 Jul 15.
PubMed 39071707
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT04650100
- Acronym / sponsor ID
- THAPeng / RC31/20/0227
- Conditions
- Postoperative Pain
- Keywords
- Total hip arthroplasty, PENG bloc, local anaesthetics infiltration, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 2 Dec 2020 (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.
The intra- and peri-articular infiltration of local anaesthetics realized at the end of total hip arthroplasty surgeries is an effective analgesic technique, but it can be insufficient to manage the possibly intense postoperative pain. Regional anaesthesia (RA) like the recently described pericapsular nerve group (PENG) block could provide additional analgesic benefit in this setting.
Investigators main objective is to demonstrate the analgesic benefits (postoperative pain score and morphine consumption) of the PENG block when added to intra- and peri-articular infiltration of local anaesthetic following total hip arthroplasty. Investigators make the assumption that i) the PENG bloc could reduce the postoperative 24 first hours morphine consumption by 30%, ii) the PENG block could spare the motor function of the quadriceps and adductor muscles, and iii) the PENG bloc could be well tolerated allowing a high level of patient satisfaction.
Detailed description
A recent study has revealed a region of pericapsular terminal branches of the femoral nerve and the obturator nerve accessible to ultrasound-guided regional anaesthesia. This technique, also called the PENG block, has recently been described with a substantial benefit on pain at rest and induced by mobilization in cases series of patients undergoing hip fracture surgery. To investigators knowledge, no randomized data concerning the analgesic efficacy of the PENG block has been published in the setting of elective total hip arthroplasty.
The PENG block would allow a significant analgesic contribution when added to intra- and peri-articular infiltration of local anaesthetics while being well tolerated with few undesirable effects. Moreover, the PENG block could spare the motor function of the quadriceps and adductor muscles allowing enhanced recovery after surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG group | Experimental | Procedure: ultrasound-guided PENG bloc realized before surgeryFor the PENG group, the ultrasound-guided PENG block (20 ml of Ropivacaine 4.75 mg/ml) is performed before the surgery. |
| Control group | No intervention | –No additional intervention, only standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for total hip arthroplasty surgery under general anaesthesia
- Affiliated of a social security scheme
- Having signed the written informed consent
Key exclusion criteria (8 listed)
- Total hip arthroplasty revision surgery
- Refusal of the patient to participate
- Existence of major spontaneous or acquired haemostasis disorders
- Infection at the puncture site
- Allergy to local anaesthetics
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 |
|---|---|---|
| ultrasound-guided PENG bloc realized before surgeryultrasound-guided PENG block realized before surgery. The PENG block, described by Giron-Arebgi is made in the supine position. The ultrasound probe used is a 5 MHz high frequency linear probe placed parallel to the line delimited by the anterior-inferior iliac spine (lateral) and the pubis (medial). The needle used is an 80 mm, 22G, needle inserted in the ultrasound plane. The slow and fractioned injection of 20 ml of Ropivacaine 4.75 mg/ml is performed in the fascia between the psoas tendon and the iliopubic eminence under ultrasound guidance. | Procedure or surgery | PENG group |
Primary outcome
Cumulated postoperative morphine consumption 24 hours after surgery
Time frame: 24 hours
calcul of Cumulated postoperative morphine consumption 24 hours after surgery
17 secondary outcomes
Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)
Time frame: Hour 1
Cumulated postoperative morphine consumption 48 hours after surgery
Time frame: Hour 48
Evaluation of pain in the PACU
Time frame: Hour 1
Evaluation of pain 24 hours after surgery
Time frame: Hour 24
Evaluation of pain 48 hours after surgery
Time frame: Hour 48
Evaluation of the pain potentially induced by the realization of the PENG block
Time frame: Hour 0
Evaluation of adverse effects associated with the PENG block
Time frame: Hour 0
Evaluation of adverse effects associated with the PENG block
Time frame: Hour 1
Evaluation of adverse effects associated with the PENG block
Time frame: Hour 24
Evaluation of adverse effects associated with the PENG block
Time frame: Hour 48
Evaluation of adverse effects associated with the use of morphine
Time frame: Hour 0
Evaluation of adverse effects associated with the use of morphine
Time frame: Hour 1
Evaluation of adverse effects associated with the use of morphine
Time frame: Hour 24
Evaluation of adverse effects associated with the use of morphine
Time frame: Hour 48
Evaluation of the patients' satisfaction
Time frame: Hour 24
Evaluation of the adductor muscles weakness
Time frame: Hour 24
Evaluation of the quadricipital muscles weakness
Time frame: Hour 24
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 28 Nov 2025.
- Results publication: PubMed 39071707Ferre F, Rey J, Bosch L, Menut R, Ferrier A, Ba C, Halimi C, Collinson I, Tissot B, Labaste F, Reina N, Minville V. Pericapsular nerve group (PENG) block combined with local infiltration analgesia is not superior to local infiltration analgesia for the management of postoperative pain after primary elective total hip arthroplasty: A prospective, randomized, controlled, single-blind trial. Heliyon. 2024 Jun 27;10(13):e33766. doi: 10.1016/j.heliyon.2024.e33766. eCollection 2024 Jul 15.
- Individual participant dataSharing planned: No
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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.
FERRE Fabrice, PH principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided PENG bloc realized before surgery in people with Postoperative Pain, run by University Hospital, Toulouse 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 3 inclusion and 8 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 28 Nov 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?
Cumulated postoperative morphine consumption 24 hours after surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650100, which also lists 1 linked publication.
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 28 Nov 2025.