Total Hip ArthroplastyPhase 4NCT04690023
PENG Block vs Supra-inguinal Fascia Iliaca Compartment Block for Postoperative Opioids Consumption and Early Motor Recovery After THA: a Randomized Controlled Non-inferiority Clinical Trial.
A Phase 4 study testing Pericapsular nerves group (PENG) block, Supra-inguinal fascia-iliaca compartment block and Ropivacaine 0,75% in PENG block in people with Total Hip Arthroplasty, run by University of Liege at 1 site in Belgium.
Trial summary
To compare the impact of pericapsular nerve group block (PENG) versus the supra-inguinal fascia-iliaca compartment block (SFICB) in postoperative analgesia, opioid sparing and enhanced recovery after surgery of total hip arthroplasty by poster-lateral approach. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Pericapsular nerves group (PENG) block, Supra-inguinal fascia-iliaca compartment block and Ropivacaine 0,75% in PENG block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2022to 1 Sep 2023
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients scheduled to undergo elective primary total hip arthroplasty by posterior surgical approach with spinal anesthesia
Who cannot join
- Patient refusal
- Allergy to administrated drugs or local infection
- Pregnancy
- History of chronic pain
- Drugs addiction
- Mental ou neurological diseases
- Kidney or liver serious diseases
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège
Liège, 4000
Michele Carella, MD, 003242843658
About this study
Official title: Comparison of Ultrasound-guided PENG Block and Supra-inguinal Fascia Iliaca Compartment Block for Postoperative Opioids Consumption and Early Motor Recovery After Total Hip Arthroplasty: a Randomized Controlled Non-inferiority Clinical Trial.
To compare the impact of pericapsular nerve group block (PENG) versus the supra-inguinal fascia-iliaca compartment block (SFICB) in postoperative analgesia, opioid sparing and enhanced recovery after surgery of total hip arthroplasty by poster-lateral approach.
Read the detailed description
ASA physical status 1, 2 and 3 patients scheduled to undergo elective total hip arthroplasty by poster-lateral (Moore) surgical approach with spinal anesthesia.
The investigators want to confirm the non-inferiority of the SFICB compared to the PENG block on postoperative first 6 hours after surgery NRS pain score and 48 hours opioids consumption, and the difference between these in terms of early recovery and motor impact on two first day after surgery. The principal investigator perform these regional anesthesia techniques with ultrasound guided injections.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Pericapsular nerves group (PENG) block, Supra-inguinal fascia-iliaca compartment block, Ropivacaine 0,75% in PENG block, Ropivacaine 0,375% in SFICB block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerves group (PENG) blockProcedure or surgery
Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block with injection 20 ml of ropivacaine 0,75%, between the anterior hip articular capsule, the ilii-psoas muscle, the ileo-pubic eminence and the antero-inferior iliac spine.
Supra-inguinal fascia-iliaca compartment blockProcedure or surgery
Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block with injection over de inguinal ligament of 40 ml of ropivacaine 0,375%, between de ilio-psoas muscle and internal oblique muscle.
Ropivacaine 0,75% in PENG blockDrug
20 ml injection of ropivacaine 0,75%
Ropivacaine 0,375% in SFICB blockDrug
40 ml injection of ropivacaine 0,375%
| Study group | Role | What they receive |
|---|---|---|
| PENG block | Active comparator | Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block. Patients in PENG group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump. Receives: Procedure: Pericapsular nerves group (PENG) block; Drug: Ropivacaine 0,75% in PENG block |
| SFICB block | Active comparator | Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block. Patients in SFICB group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump. Receives: Procedure: Supra-inguinal fascia-iliaca compartment block; Drug: Ropivacaine 0,375% in SFICB block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS 6 hours
The primary endpoint of the study will be the between-group comparisons in postoperative NRS pain scores on 0 to 10 scale.
Measured: 6 hours after surgery
Secondary outcomes (7)
6 minutes walk test
Difference in traveled distance (metres) at six minutes walking test 48 hours after surgery
Measured: 48 jours after surgery
Opioids secondaires side effects
Incidence of morphine related side effects in two groups
Measured: 48 hours after surgery
QoR-15
QoR-15 French validated questionnaire for the evaluation of recovery after surgery
Measured: 72 hours after surgery
2 minutes walk test
Difference in traveled distance (metres) at two minutes walking test 24 hours after surgery
Measured: 24 hours after surgery
Opioid sparing
Difference in cumulated morphine consumption in first 48 hours after surgery
Measured: 48 hours after intervention
DN4
Difference between the two groups in the DN4 questionnaire to assess the risk of persistent pain after surgery.
Measured: 72 hours after surgery
IPO
Pain management satisfaction score by revised American Pain Society Patient Outcomes Questionnaire (APS- POQ-R).
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jan 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690023
- Sponsor's protocol ID
- 2020/381
- Status last verified
- Jan 2022
- First submitted
- 28 Dec 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.
PubMed 30798268
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided PENG Block and Supra-inguinal Fascia Iliaca Compartment Block for Postoperative Opioids Consumption and Early Motor Recovery After Total Hip Arthroplasty: a Randomized Controlled Non-inferiority Clinical Trial.
- ClinicalTrials.gov ID
- NCT04690023
- Acronym / sponsor ID
- 2020/381
- Conditions
- Total Hip Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 30 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.
To compare the impact of pericapsular nerve group block (PENG) versus the supra-inguinal fascia-iliaca compartment block (SFICB) in postoperative analgesia, opioid sparing and enhanced recovery after surgery of total hip arthroplasty by poster-lateral approach.
Detailed description
ASA physical status 1, 2 and 3 patients scheduled to undergo elective total hip arthroplasty by poster-lateral (Moore) surgical approach with spinal anesthesia.
The investigators want to confirm the non-inferiority of the SFICB compared to the PENG block on postoperative first 6 hours after surgery NRS pain score and 48 hours opioids consumption, and the difference between these in terms of early recovery and motor impact on two first day after surgery. The principal investigator perform these regional anesthesia techniques with ultrasound guided injections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Non-inferiority randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| PENG block | Active comparator | Procedure: Pericapsular nerves group (PENG) block, Drug: Ropivacaine 0,75% in PENG blockPatients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block. Patients in PENG group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump. |
| SFICB block | Active comparator | Procedure: Supra-inguinal fascia-iliaca compartment block, Drug: Ropivacaine 0,375% in SFICB blockPatients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block. Patients in SFICB group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients scheduled to undergo elective primary total hip arthroplasty by posterior surgical approach with spinal anesthesia
Key exclusion criteria (7 listed)
- Patient refusal
- Allergy to administrated drugs or local infection
- Pregnancy
- History of chronic pain
- Drugs addiction
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 |
|---|---|---|
| Pericapsular nerves group (PENG) blockPatients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block with injection 20 ml of ropivacaine 0,75%, between the anterior hip articular capsule, the ilii-psoas muscle, the ileo-pubic eminence and the antero-inferior iliac spine. | Procedure or surgery | PENG block |
| Supra-inguinal fascia-iliaca compartment blockPatients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block with injection over de inguinal ligament of 40 ml of ropivacaine 0,375%, between de ilio-psoas muscle and internal oblique muscle. | Procedure or surgery | SFICB block |
| Ropivacaine 0,75% in PENG block20 ml injection of ropivacaine 0,75% | Drug | PENG block |
| Ropivacaine 0,375% in SFICB block40 ml injection of ropivacaine 0,375% | Drug | SFICB block |
Primary outcome
NRS 6 hours
Time frame: 6 hours after surgery
The primary endpoint of the study will be the between-group comparisons in postoperative NRS pain scores on 0 to 10 scale.
7 secondary outcomes
6 minutes walk test
Time frame: 48 jours after surgery
Opioids secondaires side effects
Time frame: 48 hours after surgery
QoR-15
Time frame: 72 hours after surgery
2 minutes walk test
Time frame: 24 hours after surgery
Opioid sparing
Time frame: 48 hours after intervention
DN4
Time frame: 72 hours after surgery
IPO
Time frame: 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Background: PubMed 30798268Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pericapsular nerves group (PENG) block, Supra-inguinal fascia-iliaca compartment block and Ropivacaine 0,75% in PENG block in people with Total Hip Arthroplasty, run by University of Liege at 1 site in Belgium.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele Carella, MD (003242843658, mcarella@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS 6 hours (time frame: 6 hours after surgery). 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 NCT04690023, which also lists 2 linked publications.
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 19 Jan 2022.