Postoperative PainNCT04231123
Pericapsular Nerve Group Block for Elective Hip Arthroplasty
A study testing PENG Block with local anesthetic and PENG Block with 0,9% saline in people with Postoperative Pain, run by Centre Hospitalier Universitaire de Tivoli at 1 site in Belgium.
Trial summary
This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- PENG Block with local anesthetic and PENG Block with 0,9% saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jan 2020to 15 Mar 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective total hip arthroplasty
- General anesthesia
- Enhanced Recovery Program
Who cannot join
- American Society of Anesthesiologists (ASA) Score > 2
- Drug allergy
- Significant psychiatric disturbances
- Preoperative opioid use
- Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid
- Body Mass Index > 40 kg/m²
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Chu Tivoli
La Louvière, 7100
Nicolas Van Rompaey, M.D.
About this study
Official title: Pericapsular Nerve Group Block for Analgesia After Hip Arthroplasty: a Randomized Double-Blind, Placebo-Controlled Trial.
This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.
Read the detailed description
Optimized analgesia is crucial for early mobilization after hip arthroplasty. Regional anesthesia, like fascia iliaca block or femoral nerve block, have limited indication because of motor blockade whereas local infiltrations analgesia have shown conflicting analgesic efficacy results in hip arthroplasty.
Pericapsular nerve group (PENG) block is a new regional anesthesia technique targeting specifically sensory nerve branches of the hip articulation. It has been originally described in hip fracture patients.
The aim of this study is to evaluate the efficacy of PENG block on analgesia after elective hip arthroplasty.
- Conditions
- Postoperative Pain
- Being tested
- PENG Block with local anesthetic, PENG Block with 0,9% saline
- Keywords
- Elective Hip Surgery, PENG Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG Block with local anestheticProcedure or surgery
After induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.
PENG Block with 0,9% salineProcedure or surgery
After induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.
| Study group | Role | What they receive |
|---|---|---|
| PENG group | Experimental | PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine Receives: Procedure: PENG Block with local anesthetic |
| Placebo group | Placebo comparator | PENG block with 20 ml of 0,9% saline Receives: Procedure: PENG Block with 0,9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score on first Mobilization
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on first mobilization at day 0 after surgery
Measured: Postoperative time until midnight day 0
Secondary outcomes (22)
Maximum Pain Score in Post-Anaesthesia Care Unit
Maximum Pain score evaluated in Post Anesthesia Care Unit by a a visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Measured: Through postoperative time during Post Anesthesia Care Unit stay at day 0
Morphine Consumption at Day 0
Total of Piritramid, Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 0
Measured: Postoperative time until midnight day 0
Piritramid Consumption
Total of Piritramid use from the end of surgery until Post Anesthesia Care Unit discharge to the ward
Measured: Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0
Morphine Consumption at Day 1
Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 1
Measured: Postoperative time during Post Anesthesia Care Unit stay at day 0
Morphine Consumption at Day 2
Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 2
Measured: Postoperative time until midnight day 2
Pain Score at Rest 2h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 2h after surgery
Measured: 2 hours after surgery
Pain Score on mobilization 2h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 2h after surgery
Measured: 2 hours after surgery
Pain Score at Rest 4h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 4h after surgery
Measured: 4 hours after surgery
Pain Score on mobilization 4h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 4h after surgery
Measured: 4 hours after surgery
Pain Score at Rest 6h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 6h after surgery
Measured: 6 hours after surgery
Pain Score on mobilization 6h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 6h after surgery
Measured: 6 hours after surgery
Pain Score at Rest Day 1 AM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 1
Measured: Day 1 in the morning after surgery
Pain Score on mobilization Day 1 AM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 1
Measured: Day 1 in the morning after surgery
Pain Score at Rest Day 1 PM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 1
Measured: Day 1 in the afternoon after surgery
Pain Score on mobilization Day 1 PM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 1
Measured: Day 1 in the afternoon after surgery
Pain Score at Rest Day 2 AM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 2
Measured: Day 2 in the morning after surgery
Pain Score on mobilization Day 2 AM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 2
Measured: Day 2 in the morning after surgery
Pain Score at Rest Day 2 PM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 2
Measured: Day 2 in the afternoon after surgery
Pain Score on mobilization Day 2 PM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 2
Measured: Day 2 in the afternoon after surgery
First Mobilization Success
Success rate of patients mobilized the day of surgery
Measured: Postoperative time until midnight day 0
Mean remifentanil Infusion Rate
Total infused remifentanil dose per kg body weight per minute of total operative time
Measured: Intraoperatively
Quadriceps weakness
Evaluation of quadriceps motricity by Neal test which consist in supporting the knee under the popliteal fossa and asking the patient to extend the knee against resistance.
Measured: Through postoperative time during Post Anesthesia Care Unit stay at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion15 Mar 2022 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Tivoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Van Rompaey, MD, Principal investigator, Centre Hospitalier Universitaire de Tivoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231123
- Sponsor's protocol ID
- P2019/482
- Other IDs
- 2019-001956-21, 2019
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 30063657
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group Block for Analgesia After Hip Arthroplasty: a Randomized Double-Blind, Placebo-Controlled Trial.
- ClinicalTrials.gov ID
- NCT04231123
- Acronym / sponsor ID
- P2019/482
- Conditions
- Postoperative Pain
- Keywords
- Elective Hip Surgery, PENG Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de TivoliUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 18 Jan 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.
This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.
Detailed description
Optimized analgesia is crucial for early mobilization after hip arthroplasty. Regional anesthesia, like fascia iliaca block or femoral nerve block, have limited indication because of motor blockade whereas local infiltrations analgesia have shown conflicting analgesic efficacy results in hip arthroplasty.
Pericapsular nerve group (PENG) block is a new regional anesthesia technique targeting specifically sensory nerve branches of the hip articulation. It has been originally described in hip fracture patients.
The aim of this study is to evaluate the efficacy of PENG block on analgesia after elective hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG group | Experimental | Procedure: PENG Block with local anestheticPENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine |
| Placebo group | Placebo comparator | Procedure: PENG Block with 0,9% salinePENG block with 20 ml of 0,9% saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective total hip arthroplasty
- General anesthesia
- Enhanced Recovery Program
Key exclusion criteria (6 listed)
- American Society of Anesthesiologists (ASA) Score > 2
- Drug allergy
- Significant psychiatric disturbances
- Preoperative opioid use
- Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid
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 |
|---|---|---|
| PENG Block with local anestheticAfter induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used. | Procedure or surgery | PENG group |
| PENG Block with 0,9% salineAfter induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used. | Procedure or surgery | Placebo group |
Primary outcome
Pain Score on first Mobilization
Time frame: Postoperative time until midnight day 0
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on first mobilization at day 0 after surgery
22 secondary outcomes
Maximum Pain Score in Post-Anaesthesia Care Unit
Time frame: Through postoperative time during Post Anesthesia Care Unit stay at day 0
Morphine Consumption at Day 0
Time frame: Postoperative time until midnight day 0
Piritramid Consumption
Time frame: Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0
Morphine Consumption at Day 1
Time frame: Postoperative time during Post Anesthesia Care Unit stay at day 0
Morphine Consumption at Day 2
Time frame: Postoperative time until midnight day 2
Pain Score at Rest 2h Postop
Time frame: 2 hours after surgery
Pain Score on mobilization 2h Postop
Time frame: 2 hours after surgery
Pain Score at Rest 4h Postop
Time frame: 4 hours after surgery
Pain Score on mobilization 4h Postop
Time frame: 4 hours after surgery
Pain Score at Rest 6h Postop
Time frame: 6 hours after surgery
Pain Score on mobilization 6h Postop
Time frame: 6 hours after surgery
Pain Score at Rest Day 1 AM
Time frame: Day 1 in the morning after surgery
Pain Score on mobilization Day 1 AM
Time frame: Day 1 in the morning after surgery
Pain Score at Rest Day 1 PM
Time frame: Day 1 in the afternoon after surgery
Pain Score on mobilization Day 1 PM
Time frame: Day 1 in the afternoon after surgery
Pain Score at Rest Day 2 AM
Time frame: Day 2 in the morning after surgery
Pain Score on mobilization Day 2 AM
Time frame: Day 2 in the morning after surgery
Pain Score at Rest Day 2 PM
Time frame: Day 2 in the afternoon after surgery
Pain Score on mobilization Day 2 PM
Time frame: Day 2 in the afternoon after surgery
First Mobilization Success
Time frame: Postoperative time until midnight day 0
Mean remifentanil Infusion Rate
Time frame: Intraoperatively
Quadriceps weakness
Time frame: Through postoperative time during Post Anesthesia Care Unit stay at day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- 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.
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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.
Nicolas Van Rompaey, MD principal investigator
Centre Hospitalier Universitaire de Tivoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG Block with local anesthetic and PENG Block with 0,9% saline in people with Postoperative Pain, run by Centre Hospitalier Universitaire de Tivoli 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 3 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: status not confirmed, as of the sponsor's last update on 27 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Van Rompaey, MD (+3264276111, nvrompae@chu-tivoli.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score on first Mobilization (time frame: Postoperative time until midnight day 0). 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 NCT04231123, 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 27 Jan 2021.