Total Hip ArthroplastyNCT05212038
An Iliopsoas Plane Block After Total Hip Arthroplasty
A study testing iliopsoas plane block group in people with Total Hip Arthroplasty, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Nielsen et al. reported that when iliopsoas plane block was performed on healthy volunteers, the injection solution in Hip MRI was confined to the myofascial compartment, which was known to include all sensory branches of the femoral nerve that control the hip joint. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- iliopsoas plane block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2022to 5 Jan 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
- Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
- ASA PS 1-3
Who cannot join
- Revision total hip arthroplasty
- Allergy to drugs used in the study
- Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
- Estimated glomerular filtration rate < 30 mL/min/1.73m2
- Opioid dependence
- Prolongation of PT and aPTT more than twice the upper limit of normal
- Pre-existing neurological or anatomical disorders of the lower extremities
- Serious psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Iliopsoas Plane Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Nielsen et al. reported that when iliopsoas plane block was performed on healthy volunteers, the injection solution in Hip MRI was confined to the myofascial compartment, which was known to include all sensory branches of the femoral nerve that control the hip joint. The maximal muscle strength of knee extension did not decrease before and after Iliopsoas plane block in Volunteer. Since there is no clinical study conducted on patients after the volunteer study, the investigators intend to evaluate the analgesic and motor preserving effects of the iliopsoas plane block in a group of patients undergoing total hip arthroplasty.
- Conditions
- Total Hip Arthroplasty
- Being tested
- iliopsoas plane block group, sham block group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iliopsoas plane block groupProcedure or surgery
Ultrasound-guided iliopsoas plane block with 0.75% ropivacaine 10 ml and epinephrine 0.05 ml (1:200,000) 10 ml
sham block groupProcedure or surgery
Ultrasound-guided iliopsoas plane block with normal saline 10 ml
| Study group | Role | What they receive |
|---|---|---|
| liopsoas plane block group | Experimental | Arm Description: a iliopsoas plane block before surgery Receives: Procedure: iliopsoas plane block group |
| sham block group | Sham comparator | sham block before surgery Receives: Procedure: sham block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale pain score at rest
Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 6, 24, and 48 hours after the surgery.
Measured: up to 48 hours after the surgery
Secondary outcomes (2)
Numeric rating scale pain score at movement
Pain intensity 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) 1, 6, 24, and 48 hours after the surgery.
Measured: up to 48 hours postoperatively
Postoperative opioid consumption
morphine equivalent dose
Measured: postoperative 24, 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start15 Feb 2022
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
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 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212038
- Sponsor's protocol ID
- 3-2021-0438
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JY, Lee JS, Kim JY, Yoon EJ, Lee W, Lee S, Kim DH. Iliopsoas plane block does not improve pain after primary total hip arthroplasty in the presence of multimodal analgesia: a single institution randomized controlled trial. Reg Anesth Pain Med. 2025 Mar 5;50(3):257-263. doi: 10.1136/rapm-2023-105092.
PubMed 38286736
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Iliopsoas Plane Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05212038
- Acronym / sponsor ID
- 3-2021-0438
- Conditions
- Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 27 Jan 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.
Nielsen et al. reported that when iliopsoas plane block was performed on healthy volunteers, the injection solution in Hip MRI was confined to the myofascial compartment, which was known to include all sensory branches of the femoral nerve that control the hip joint. The maximal muscle strength of knee extension did not decrease before and after Iliopsoas plane block in Volunteer. Since there is no clinical study conducted on patients after the volunteer study, the investigators intend to evaluate the analgesic and motor preserving effects of the iliopsoas plane block in a group of 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
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| liopsoas plane block group | Experimental | Procedure: iliopsoas plane block groupArm Description: a iliopsoas plane block before surgery |
| sham block group | Sham comparator | Procedure: sham block groupsham block before surgery |
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 19 years of age or older who are expected to undergo unilateral hip arthroplasty
- ASA PS 1-3
Key exclusion criteria (8 listed)
- Revision total hip arthroplasty
- Allergy to drugs used in the study
- Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
- Estimated glomerular filtration rate < 30 mL/min/1.73m2
- Opioid dependence
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 |
|---|---|---|
| iliopsoas plane block groupUltrasound-guided iliopsoas plane block with 0.75% ropivacaine 10 ml and epinephrine 0.05 ml (1:200,000) 10 ml | Procedure or surgery | liopsoas plane block group |
| sham block groupUltrasound-guided iliopsoas plane block with normal saline 10 ml | Procedure or surgery | sham block group |
Primary outcome
Numeric rating scale pain score at rest
Time frame: up to 48 hours after the surgery
Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 6, 24, and 48 hours after the surgery.
2 secondary outcomes
Numeric rating scale pain score at movement
Time frame: up to 48 hours postoperatively
Postoperative opioid consumption
Time frame: postoperative 24, 48hours
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 15 Feb 2023.
- Derived from this study: PubMed 38286736Kim JY, Lee JS, Kim JY, Yoon EJ, Lee W, Lee S, Kim DH. Iliopsoas plane block does not improve pain after primary total hip arthroplasty in the presence of multimodal analgesia: a single institution randomized controlled trial. Reg Anesth Pain Med. 2025 Mar 5;50(3):257-263. doi: 10.1136/rapm-2023-105092.
- 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.
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 iliopsoas plane block group in people with Total Hip Arthroplasty, run by Gangnam Severance Hospital 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 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 15 Feb 2023. 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. 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?
Numeric rating scale pain score at rest (time frame: up to 48 hours after the 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 NCT05212038, 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 15 Feb 2023.