Total Hip ArthroplastyNCT04426045
Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
A study testing Pericapsular nerve group block and Supra-inguinal fascia iliaca compartment block in people with Total Hip Arthroplasty and Postoperative Pain, run by Yonsei University at 1 site in South Korea.
Trial summary
Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The supra-inguinal fascia iliaca compartment block has been described as a promising technique for primary total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Total Hip Arthroplasty, Postoperative Pain
- What is being tested?
- Pericapsular nerve group block and Supra-inguinal fascia iliaca compartment block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jul 2020to 10 Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3
- scheduled for elective unilateral total hip arthroplasty
Who cannot join
- Allergy or intolerance to any of the drugs used in the study
- Hepatic or renal insufficiency
- Opioid dependency
- Coagulopathy
- Pre-existing neurologic or anatomic deficits in the lower extremities
- Severe psychiatric illness
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul
About this study
Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The supra-inguinal fascia iliaca compartment block has been described as a promising technique for primary total hip arthroplasty. However, one of the concerns with supra-inguinal fascia iliaca compartment block is still the potential for quadriceps weakness that might delay ambulation. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block is possible to provide sufficient analgesia and preserve lower limb muscle strength. The investigators will compare ultrasound-guided supra-inguinal fascia iliaca compartment block with PENG block in patients undergoing total hip arthroplasty.
- Conditions
- Total Hip Arthroplasty, Postoperative Pain
- Being tested
- Pericapsular nerve group block, Supra-inguinal fascia iliaca compartment 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.
Pericapsular nerve group blockProcedure or surgery
Also called PENG block
A curvilinear 2-5MHz ultrasound probe will be initially placed in a transverse plane over the anterior superior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be 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. A total volume of 20 ml of ropivacaine 0.2% will be injected.
Supra-inguinal fascia iliaca compartment blockProcedure or surgery
Also called Supra-inguinal FICB
A linear 6-13-MHz ultrasound probe will be placed in the sagittal plane to obtain an image of the anterior superior iliac spine. The fascia iliaca and sartorius, iliopsoas, and oblique internal muscles will be identified by sliding the probe medially. After identifying the "bow-tie sign" formed by the muscle fascias, a 22-gauge, 80-mm needle will be introduced 1 cm cephalad to the inguinal ligament. Using an in-plane approach, the fascia iliaca will be penetrated and hydrodissected, separating the fascia iliaca from the iliac muscle. A total volume of 30 ml of ropivacaine 0.2% will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular nerve group block | Experimental | Participants receiving pericapsular nerve group block Receives: Procedure: Pericapsular nerve group block |
| Supra-inguinal fascia iliaca compartment block | Active comparator | Participants receiving supra-inguinal fascia iliaca compartment block Receives: Procedure: Supra-inguinal fascia iliaca compartment block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale pain score
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
Measured: 1 hour after the surgery
Numeric rating scale pain score
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
Measured: 6 hours after the surgery
Numeric rating scale pain score
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
Measured: 24 hours after the surgery
Numeric rating scale pain score
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
Measured: 36 hours after the surgery
Numeric rating scale pain score
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
Measured: 48 hours after the surgery
Secondary outcomes (4)
Quadriceps muscle strength
Quadriceps muscle strength will be measured by the dynamometer
Measured: baseline
Quadriceps muscle strength
Quadriceps muscle strength will be measured by the dynamometer
Measured: at 6 hours postoperatively
Quadriceps muscle strength
Quadriceps muscle strength will be measured by the dynamometer
Measured: at 24 hours postoperatively
Quadriceps muscle strength
Quadriceps muscle strength will be measured by the dynamometer
Measured: at 36 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start21 Jul 2020
- Primary completion6 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426045
- Sponsor's protocol ID
- 4-2020-0417
- Status last verified
- Jul 2021
- First submitted
- 8 Jun 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04426045
- Acronym / sponsor ID
- 4-2020-0417
- Conditions
- Total Hip Arthroplasty, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 11 Jun 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.
Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The supra-inguinal fascia iliaca compartment block has been described as a promising technique for primary total hip arthroplasty. However, one of the concerns with supra-inguinal fascia iliaca compartment block is still the potential for quadriceps weakness that might delay ambulation. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block is possible to provide sufficient analgesia and preserve lower limb muscle strength. The investigators will compare ultrasound-guided supra-inguinal fascia iliaca compartment block with PENG block in patients undergoing total hip arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular nerve group block | Experimental | Procedure: Pericapsular nerve group blockParticipants receiving pericapsular nerve group block |
| Supra-inguinal fascia iliaca compartment block | Active comparator | Procedure: Supra-inguinal fascia iliaca compartment blockParticipants receiving supra-inguinal fascia iliaca compartment block |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3
- scheduled for elective unilateral total hip arthroplasty
Key exclusion criteria (6 listed)
- Allergy or intolerance to any of the drugs used in the study
- Hepatic or renal insufficiency
- Opioid dependency
- Coagulopathy
- Pre-existing neurologic or anatomic deficits in the lower extremities
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 blockAlso: PENG blockA curvilinear 2-5MHz ultrasound probe will be initially placed in a transverse plane over the anterior superior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be 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. A total volume of 20 ml of ropivacaine 0.2% will be injected. | Procedure or surgery | Pericapsular nerve group block |
| Supra-inguinal fascia iliaca compartment blockAlso: Supra-inguinal FICBA linear 6-13-MHz ultrasound probe will be placed in the sagittal plane to obtain an image of the anterior superior iliac spine. The fascia iliaca and sartorius, iliopsoas, and oblique internal muscles will be identified by sliding the probe medially. After identifying the "bow-tie sign" formed by the muscle fascias, a 22-gauge, 80-mm needle will be introduced 1 cm cephalad to the inguinal ligament. Using an in-plane approach, the fascia iliaca will be penetrated and hydrodissected, separating the fascia iliaca from the iliac muscle. A total volume of 30 ml of ropivacaine 0.2% will be injected. | Procedure or surgery | Supra-inguinal fascia iliaca compartment block |
Primary outcome
Numeric rating scale pain score
Time frame: 1 hour after the surgery
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
Numeric rating scale pain score
Time frame: 6 hours after the surgery
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
Numeric rating scale pain score
Time frame: 24 hours after the surgery
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
Numeric rating scale pain score
Time frame: 36 hours after the surgery
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
Numeric rating scale pain score
Time frame: 48 hours after the surgery
Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
4 secondary outcomes
Quadriceps muscle strength
Time frame: baseline
Quadriceps muscle strength
Time frame: at 6 hours postoperatively
Quadriceps muscle strength
Time frame: at 24 hours postoperatively
Quadriceps muscle strength
Time frame: at 36 hours 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 20 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Total Hip Arthroplasty
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
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?
A study testing Pericapsular nerve group block and Supra-inguinal fascia iliaca compartment block in people with Total Hip Arthroplasty and Postoperative Pain, run by Yonsei University at 1 site in South Korea.
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 2 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 20 Jul 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 South Korea. 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?
Numeric rating scale pain score (time frame: 1 hour after the surgery). The study lists 5 primary outcomes in all. 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 20 Jul 2021.