Hip ArthropathyNCT04295408
Pericapsular Nerve Group Block for Total Hip Arthroplasty
A study testing Pericapsular nerve group block with saline solution and Pericapsular nerve group block with ropivacaine in people with Hip Arthropathy and Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Controlling pain after hip replacement surgery improves comfort and partient satisfaction. Pain after hip replacement has traditionally been managed using systemic pain medications including acetaminophen and non-steroidal anti-inflammatory drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy, Postoperative Pain
- What is being tested?
- Pericapsular nerve group block with saline solution and Pericapsular nerve group block with ropivacaine
- 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 siteTunisia
- Study dates
- 30 Apr 2020to 31 Dec 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
- primary THA with lateral approach under general anesthesia.
Who cannot join
- Hip fracture,
- allergy to local anesthetics,
- peripheral neuropathy,
- creatinin clearance inferior to 30ml/min,
- weight inferior to 50 Kg or superior to 100 Kg,
- neurological disorder affecting the lower extremity, significant psychiatric conditions,
- patients receiving corticosteroid therapy,
- chronic consumption of opioids (>2 months).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pericapsular Nerve Group Block After Total Hip Arthroplasty Surgery
Controlling pain after hip replacement surgery improves comfort and partient satisfaction. Pain after hip replacement has traditionally been managed using systemic pain medications including acetaminophen and non-steroidal anti-inflammatory drugs. A recent Cochrane review demonstrated that compared to systemic analgesia alone, peripheral nerve blocks reduce postoperative pain with moderate-quality evidence. Pericapsular Nerve Group block is a new technique allowing local anesthetic diffusion to femoral, obturator and accessory obturator nerves and providing a good analgesic effect for hip fracture surgery. Investigators hypothesized that the PENG block could be an interesting alternative to systemic analgesiscs for pain control after total hip replacement.
Read the detailed description
The aim of the study was to evaluate the efficacy of the PENG block for intra and postoperative pain control in total hip arthroplasty.
it was a monocentric, randomized, controlled and double blind study. Patients scheduled for primary THA with lateral approach under general anesthesia.
Premedication with IV midazolam 1 to 2 mg on arrival to operating theatre. general anesthesia was conducted using fentanyl, propofol and cisatracurium for induction and isoflurane for maintanance patients were randomized using a random table in two groups:
- PENG Block group (PG) who received 2 mg.kg-1Ropivacaine in 40 ml of saline.
- Placebo group (SG) who received 40 ml of saline.
Postoperative analgesia started before extubation of the patient, with:
- IV paracetamol 1g/6h in Day1 and oral paracetamol 1g/8h for 6 days.
- non steroidal anti inflammatory drugs with IM piroxicam 20 mg on day one (at the end of surgery) and oral diclofenac 50 mg/12h for 3 days.
- Morphine PCA for day 1 (24 H) and oral tramadol 50 mg/12h from day 2 to day 6.
- Conditions
- Hip Arthropathy, Postoperative Pain
- Being tested
- Pericapsular nerve group block with saline solution, Pericapsular nerve group block with ropivacaine
- Keywords
- hip arthoplasty, nerve block, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group block with saline solutionProcedure or surgery
A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the saline solution was injected in 5-mL increments while observing for adequate fluid spread in this plane.a total volune of 40 ml saline solution was injected.
Pericapsular nerve group block with ropivacaineProcedure or surgery
A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, local anesthetic was injected in 5-mL increments while observing for adequate fluid spread in this plane. a 2 mg.kg-1Ropivacaine in 40 ml of saline was injected
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Pericapsular Nerve Group block with 40 ml saline Receives: Procedure: Pericapsular nerve group block with saline solution |
| Pericapsular nerve group block | Experimental | Pericapsular Nerve Group block with 2 mg.kg-1Ropivacaine in 40 ml of saline Receives: Procedure: Pericapsular nerve group block with ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
morphine consumption on mg
Measured: day one
Secondary outcomes (4)
intraoperative opioid consumption
total intraoperative fentanyl consumption on microg
Measured: Day 0
Pain score after extubation
simplified numerical score (SNS) after extubation [0=no pain , 10=worst pain].
Measured: up to 30 minutes
postoperative pain score
simplified numerical score (SNS) [0=no pain , 10=worst pain].
Measured: day one
Pain score during seating position
simplified numerical score (SNS) during seating position [0=no pain , 10=worst pain].
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start30 Apr 2020
- Primary completion30 Apr 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olfa kaabachi, MD, University Tunis El Manar
- Investigators
- khaireddine Raddaoui, MD, Principal investigator, Tunis El Manar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295408
- Sponsor's protocol ID
- CE-IMKO 103/2019
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pericapsular Nerve Group Block After Total Hip Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT04295408
- Acronym / sponsor ID
- CE-IMKO 103/2019
- Conditions
- Hip Arthropathy, Postoperative Pain
- Keywords
- hip arthoplasty, nerve block, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Mar 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.
Controlling pain after hip replacement surgery improves comfort and partient satisfaction. Pain after hip replacement has traditionally been managed using systemic pain medications including acetaminophen and non-steroidal anti-inflammatory drugs. A recent Cochrane review demonstrated that compared to systemic analgesia alone, peripheral nerve blocks reduce postoperative pain with moderate-quality evidence. Pericapsular Nerve Group block is a new technique allowing local anesthetic diffusion to femoral, obturator and accessory obturator nerves and providing a good analgesic effect for hip fracture surgery. Investigators hypothesized that the PENG block could be an interesting alternative to systemic analgesiscs for pain control after total hip replacement.
Detailed description
The aim of the study was to evaluate the efficacy of the PENG block for intra and postoperative pain control in total hip arthroplasty.
it was a monocentric, randomized, controlled and double blind study. Patients scheduled for primary THA with lateral approach under general anesthesia.
Premedication with IV midazolam 1 to 2 mg on arrival to operating theatre. general anesthesia was conducted using fentanyl, propofol and cisatracurium for induction and isoflurane for maintanance patients were randomized using a random table in two groups:
- PENG Block group (PG) who received 2 mg.kg-1Ropivacaine in 40 ml of saline.
- Placebo group (SG) who received 40 ml of saline.
Postoperative analgesia started before extubation of the patient, with:
- IV paracetamol 1g/6h in Day1 and oral paracetamol 1g/8h for 6 days.
- non steroidal anti inflammatory drugs with IM piroxicam 20 mg on day one (at the end of surgery) and oral diclofenac 50 mg/12h for 3 days.
- Morphine PCA for day 1 (24 H) and oral tramadol 50 mg/12h from day 2 to day 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Procedure: Pericapsular nerve group block with saline solutionPericapsular Nerve Group block with 40 ml saline |
| Pericapsular nerve group block | Experimental | Procedure: Pericapsular nerve group block with ropivacainePericapsular Nerve Group block with 2 mg.kg-1Ropivacaine in 40 ml of saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary THA with lateral approach under general anesthesia.
Key exclusion criteria (8 listed)
- Hip fracture,
- allergy to local anesthetics,
- peripheral neuropathy,
- creatinin clearance inferior to 30ml/min,
- weight inferior to 50 Kg or superior to 100 Kg,
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 nerve group block with saline solutionA curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the saline solution was injected in 5-mL increments while observing for adequate fluid spread in this plane.a total volune of 40 ml saline solution was injected. | Procedure or surgery | PLACEBO |
| Pericapsular nerve group block with ropivacaineA curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, local anesthetic was injected in 5-mL increments while observing for adequate fluid spread in this plane. a 2 mg.kg-1Ropivacaine in 40 ml of saline was injected | Procedure or surgery | Pericapsular nerve group block |
Primary outcome
Total morphine consumption
Time frame: day one
morphine consumption on mg
4 secondary outcomes
intraoperative opioid consumption
Time frame: Day 0
Pain score after extubation
Time frame: up to 30 minutes
postoperative pain score
Time frame: day one
Pain score during seating position
Time frame: day one
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 13 Feb 2024.
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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.
khaireddine Raddaoui, MD principal investigator
Tunis El Manar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group block with saline solution and Pericapsular nerve group block with ropivacaine in people with Hip Arthropathy and Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
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 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 13 Feb 2024. 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 Tunisia. 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?
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?
Total morphine consumption (time frame: day one). 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 13 Feb 2024.