Total Hip Arthroplasty, Postoperative PainNCT05320913
Pericapsular Nerve Group (PENG) Block Combined With Periarticular Multimodal Drug Injection (PMDI) Versus Isolated PMDI for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
A study testing Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI) and isolated periarticular multimodal drug injection (PMDI) in people with Total Hip Arthroplasty, 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. However, there is no consensus about optimal pain control after post operation. In general, the periarticular multimodal durg injection block has been done for pain control in 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(PENG) block combined with periarticular multimodal drug injection (PMDI) and isolated periarticular multimodal drug injection (PMDI)
- Type of treatment
- Injection or infusion, 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
- 4 Apr 2022to 13 Dec 2023
- 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
- 1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and 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, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Kwankyu Park, 82-2-2228-2183, kkpark@yuhs.ac
About this study
Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. However, there is no consensus about optimal pain control after post operation. In general, the periarticular multimodal durg injection block has been done for pain control in primary total hip arthroplasty. 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 PENG and PMDI block with isolated PMDI block in patients undergoing total hip arthroplasty.
- Being tested
- Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI), isolated periarticular multimodal drug injection (PMDI)
- 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(PENG) block combined with periarticular multimodal drug injection (PMDI)Procedure or surgery
Also called PENG + PMDI block
periarticular local anesthetic infiltration with 120 mg of ropivacaine, epinephrine 0.2 mg and 30 mg of ketorolac diluted with normal saline to a total volume of 40 mL. + PENG block with ropivacaine 40 mg and epinephrine 0.1 mg with normal saline to a total volume of 20 mL
isolated periarticular multimodal drug injection (PMDI)Procedure or surgery
Also called Isolated PMDI block
periarticular local anesthetic infiltration with 150 mg of ropivacaine, epinephrine 0.3 mg and 30 mg of ketorolac diluted with normal saline to a total volume of 50 mL
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI) | Experimental | Participants receiving pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI) Receives: Procedure: Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI) |
| isolated periarticular multimodal drug injection (PMDI) | Active comparator | Arm Description: Participants receiving isolated periarticular multimodal drug injection (PMDI) Receives: Procedure: isolated periarticular multimodal drug injection (PMDI) |
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 evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 24 hours postoperatively
Measured: at 24 hours postoperatively
Secondary outcomes (1)
Pain score measured at 6 hours postoperatively and 48 hours postoperatively
Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 6 hours postoperatively and 48h postoperatively
Measured: Pain score measured at 6 hours postoperatively and 48 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 Apr 2022
- Study start4 Apr 2022
- Primary completion13 Dec 2023 (estimated)
- Study completion13 Dec 2023 (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 Total Hip Arthroplasty, Postoperative PainStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kwankyu Park, Principal investigator, Department of orthopaedic surgery, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320913
- Sponsor's protocol ID
- 4-2021-1482
- Status last verified
- May 2022
- First submitted
- 3 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cho HS, Lee BR, Kwon HM, Park JY, Ham HW, Lee WS, Park KK, Lee TS, Choi YS. Pericapsular Nerve Group Block with Periarticular Injection for Pain Management after Total Hip Arthroplasty: A Randomized Controlled Trial. Yonsei Med J. 2025 Apr;66(4):233-239. doi: 10.3349/ymj.2024.0098.
PubMed 40134083
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block Combined With Periarticular Multimodal Drug Injection (PMDI) Versus Isolated PMDI for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05320913
- Acronym / sponsor ID
- 4-2021-1482
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 13 Dec 2023 (estimated)
- Study completion
- 13 Dec 2023 (estimated)
- First posted
- 11 Apr 2022 (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. However, there is no consensus about optimal pain control after post operation. In general, the periarticular multimodal durg injection block has been done for pain control in primary total hip arthroplasty. 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 PENG and PMDI block with isolated PMDI 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(PENG) block combined with periarticular multimodal drug injection (PMDI) | Experimental | Procedure: Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI)Participants receiving pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI) |
| isolated periarticular multimodal drug injection (PMDI) | Active comparator | Procedure: isolated periarticular multimodal drug injection (PMDI)Arm Description: Participants receiving isolated periarticular multimodal drug injection (PMDI) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and 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(PENG) block combined with periarticular multimodal drug injection (PMDI)Also: PENG + PMDI blockperiarticular local anesthetic infiltration with 120 mg of ropivacaine, epinephrine 0.2 mg and 30 mg of ketorolac diluted with normal saline to a total volume of 40 mL. + PENG block with ropivacaine 40 mg and epinephrine 0.1 mg with normal saline to a total volume of 20 mL | Procedure or surgery | Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI) |
| isolated periarticular multimodal drug injection (PMDI)Also: Isolated PMDI blockperiarticular local anesthetic infiltration with 150 mg of ropivacaine, epinephrine 0.3 mg and 30 mg of ketorolac diluted with normal saline to a total volume of 50 mL | Procedure or surgery | isolated periarticular multimodal drug injection (PMDI) |
Primary outcome
Numeric rating scale pain score
Time frame: at 24 hours postoperatively
Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 24 hours postoperatively
1 secondary outcome
Pain score measured at 6 hours postoperatively and 48 hours postoperatively
Time frame: Pain score measured at 6 hours postoperatively and 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Derived from this study: PubMed 40134083Cho HS, Lee BR, Kwon HM, Park JY, Ham HW, Lee WS, Park KK, Lee TS, Choi YS. Pericapsular Nerve Group Block with Periarticular Injection for Pain Management after Total Hip Arthroplasty: A Randomized Controlled Trial. Yonsei Med J. 2025 Apr;66(4):233-239. doi: 10.3349/ymj.2024.0098.
- Individual participant dataSharing planned: Undecided
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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.
Kwankyu Park principal investigator
Department of orthopaedic surgery, Yonsei University College of Medicine
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(PENG) block combined with periarticular multimodal drug injection (PMDI) and isolated periarticular multimodal drug injection (PMDI) in people with Total Hip Arthroplasty, 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 1 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 3 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwankyu Park (82-2-2228-2183, kkpark@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale pain score (time frame: at 24 hours postoperatively). 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 NCT05320913, 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 3 May 2022.