Acute PainNCT06337968
CPB for Arthroscopic Hip Surgery
A study testing Circum-psoas Block in people with Acute Pain and Opioid Use, run by The Second Hospital of Shandong University.
Trial summary
Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pain, Opioid Use
- What is being tested?
- Circum-psoas Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary unilateral ambulatory hip arthroscopy
- Age 18 to 70 years
- ASA physical status I to III
- Ability to follow the protocol.
Who cannot join
- Age <18 or >70 years of age
- BMI above 40
- Contraindications to peripheral nerve blockade
- Pregnancy
- Chronic pain condition requiring opioid intake at home
- Allergy to opioids or local anesthetics
- Patient refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Circum-Psoas Block for Arthroscopic Hip Surgery: A Randomized Trial
Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Postoperative pain reduces patient satisfaction and delay patient recovery and discharge. The efficacy of regional anesthesia techniques in postoperative pain management have been proved in various surgeries. However, it remains controversial whether or not peripheral nerve blocks can significantly improve postoperative analgesia after hip arthroscopy.
Several studies have shown that the fascia iliac block cannot improve postoperative analgesia for hip arthroscopy because it blocks only some branches of the lumbar plexus but not the sacral plexus. Circum-Psoas Block (CPB) which has been defined in recent years is able to block the lumbar plexus nerves as well as sacral plexus such as the sciatic, superior gluteal, and inferior gluteal nerves. Therefore, the investigators predict that it can provide effective postoperative analgesia for hip arthroscopy. In this study, the researchers aim to investigate the effectiveness of CPB in hip arthroscopy.
- Conditions
- Acute Pain, Opioid Use
- Being tested
- Circum-psoas Block, Sham block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circum-psoas BlockProcedure or surgery
Ultrasound-guided circum-psoas block with 40 mL of treatment drug (Ropivacaine 0.2% [local anesthetic]) 30 minutes prior to induction of anesthesia.
Sham blockProcedure or surgery
Perform ultrasound scanning without puncture.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided circum-psoas block | Active comparator | Injection of 20ml 0.2% ropivacaine around the antero-lateral margin of psoas major muscle at the level of iliac crest with an in-plane approach under ultrasound guidance. Then the transducer was placed at the level of Lumbar vertebra 5 to obtain the paramedian transverse plane of the intertransverse ligament and lumbosacral ligament. An additional 20ml 0.2% ropivacaine was injected when the needle punctured the lumbosacral ligament. Receives: Procedure: Circum-psoas Block |
| Sham block | Placebo comparator | Perform ultrasound scanning without puncture. Receives: Procedure: Sham block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity at 6 hours postoperatively
Postoperative pain assessed with NRS pain score (NRS 0: no pain 10: pain as bad as can be) at 1, 6, 12, 24 hours postoperatively. However, to be more precise in our assessment, the effectiveness of each intervention was defined as a reduction in the pain at 6 hours postoperatively.
Measured: 6 hours postoperatively
Secondary outcomes (4)
Postoperative opioid consumption
Cumulative 24-hr postoperative opioid consumption
Measured: up to the first 24 hours postoperatively
Postoperative nausea and vomiting
Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).
Measured: up to the first 24 hours postoperatively
neurologic evaluation
The dermatomal coverage of sensory block was evaluated by using a cool roller at 1, 6, 24 hours post-surgery. Motor strength was assessed by the following criteria (0: none; 1: muscle flicker without movement; 2: movement, but not against gravity; 3: movement against gravity; 4: movement against some resistance; 5: normal strength).
Measured: 1, 6, 24 hours postoperatively
Patient satisfaction
Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Measured: at the end of 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Li, Doctor, Study director, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337968
- Sponsor's protocol ID
- Circum-Psoas Block LN
- Status last verified
- Nov 2024
- First submitted
- 24 Mar 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garner M, Alshameeri Z, Sardesai A, Khanduja V. A Prospective Randomized Controlled Trial Comparing the Efficacy of Fascia Iliaca Compartment Block Versus Local Anesthetic Infiltration After Hip Arthroscopic Surgery. Arthroscopy. 2017 Jan;33(1):125-132. doi: 10.1016/j.arthro.2016.10.010.
PubMed 28003068Baker JF, McGuire CM, Byrne DP, Hunter K, Eustace N, Mulhall KJ. Analgesic control after hip arthroscopy: a randomised, double-blinded trial comparing portal with intra-articular infiltration of bupivacaine. Hip Int. 2011 May-Jun;21(3):373-7. doi: 10.5301/HIP.2011.8390. Epub 2011 Jun 7.
PubMed 21698591Zheng J, Mi Y, Liang J, Li H, Shao P, Wen H, Wang Y. Circum-Psoas Block versus Supra-Inguinal Fascia Iliaca Block for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: A Randomized Clinical Trial. J Pain Res. 2023 Nov 20;16:3961-3970. doi: 10.2147/JPR.S435159. eCollection 2023.
PubMed 38026457
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circum-Psoas Block for Arthroscopic Hip Surgery: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06337968
- Acronym / sponsor ID
- Circum-Psoas Block LN
- Conditions
- Acute Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Mar 2024 (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.
Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Postoperative pain reduces patient satisfaction and delay patient recovery and discharge. The efficacy of regional anesthesia techniques in postoperative pain management have been proved in various surgeries. However, it remains controversial whether or not peripheral nerve blocks can significantly improve postoperative analgesia after hip arthroscopy.
Several studies have shown that the fascia iliac block cannot improve postoperative analgesia for hip arthroscopy because it blocks only some branches of the lumbar plexus but not the sacral plexus. Circum-Psoas Block (CPB) which has been defined in recent years is able to block the lumbar plexus nerves as well as sacral plexus such as the sciatic, superior gluteal, and inferior gluteal nerves. Therefore, the investigators predict that it can provide effective postoperative analgesia for hip arthroscopy. In this study, the researchers aim to investigate the effectiveness of CPB in hip arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided circum-psoas block | Active comparator | Procedure: Circum-psoas BlockInjection of 20ml 0.2% ropivacaine around the antero-lateral margin of psoas major muscle at the level of iliac crest with an in-plane approach under ultrasound guidance. Then the transducer was placed at the level of Lumbar vertebra 5 to obtain the paramedian transverse plane of the intertransverse ligament and lumbosacral ligament. An additional 20ml 0.2% ropivacaine was injected when the needle punctured the lumbosacral ligament. |
| Sham block | Placebo comparator | Procedure: Sham blockPerform ultrasound scanning without puncture. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary unilateral ambulatory hip arthroscopy
- Age 18 to 70 years
- ASA physical status I to III
- Ability to follow the protocol.
Key exclusion criteria (7 listed)
- Age <18 or >70 years of age
- BMI above 40
- Contraindications to peripheral nerve blockade
- Pregnancy
- Chronic pain condition requiring opioid intake at home
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 |
|---|---|---|
| Circum-psoas BlockUltrasound-guided circum-psoas block with 40 mL of treatment drug (Ropivacaine 0.2% [local anesthetic]) 30 minutes prior to induction of anesthesia. | Procedure or surgery | Ultrasound guided circum-psoas block |
| Sham blockPerform ultrasound scanning without puncture. | Procedure or surgery | Sham block |
Primary outcome
pain severity at 6 hours postoperatively
Time frame: 6 hours postoperatively
Postoperative pain assessed with NRS pain score (NRS 0: no pain 10: pain as bad as can be) at 1, 6, 12, 24 hours postoperatively. However, to be more precise in our assessment, the effectiveness of each intervention was defined as a reduction in the pain at 6 hours postoperatively.
4 secondary outcomes
Postoperative opioid consumption
Time frame: up to the first 24 hours postoperatively
Postoperative nausea and vomiting
Time frame: up to the first 24 hours postoperatively
neurologic evaluation
Time frame: 1, 6, 24 hours postoperatively
Patient satisfaction
Time frame: at the end of 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Results publication: PubMed 28003068Garner M, Alshameeri Z, Sardesai A, Khanduja V. A Prospective Randomized Controlled Trial Comparing the Efficacy of Fascia Iliaca Compartment Block Versus Local Anesthetic Infiltration After Hip Arthroscopic Surgery. Arthroscopy. 2017 Jan;33(1):125-132. doi: 10.1016/j.arthro.2016.10.010.
- Results publication: PubMed 21698591Baker JF, McGuire CM, Byrne DP, Hunter K, Eustace N, Mulhall KJ. Analgesic control after hip arthroscopy: a randomised, double-blinded trial comparing portal with intra-articular infiltration of bupivacaine. Hip Int. 2011 May-Jun;21(3):373-7. doi: 10.5301/HIP.2011.8390. Epub 2011 Jun 7.
- Results publication: PubMed 38026457Zheng J, Mi Y, Liang J, Li H, Shao P, Wen H, Wang Y. Circum-Psoas Block versus Supra-Inguinal Fascia Iliaca Block for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: A Randomized Clinical Trial. J Pain Res. 2023 Nov 20;16:3961-3970. doi: 10.2147/JPR.S435159. eCollection 2023.
- 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.
Ning Li, Doctor study director
The Second Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A study testing Circum-psoas Block in people with Acute Pain and Opioid Use, run by The Second Hospital of Shandong University.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, Doctor (86+13791036442, lining252252@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain severity at 6 hours postoperatively (time frame: 6 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 NCT06337968, which also lists 3 linked publications.
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 25 Nov 2024.