CPB for Arthroscopic Hip Surgery

NCT06337968 | Not Yet Recruiting DMC

• 1 other identifier: Circum-Psoas Block LN
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 hours postoperatively

Secondary Outcomes (4)

• Postoperative opioid consumption

  up to the first 24 hours postoperatively

• Postoperative nausea and vomiting

  up to the first 24 hours postoperatively

• neurologic evaluation

  1, 6, 24 hours postoperatively

• Patient satisfaction

  at the end of 24 hours postoperatively

Study Arms (2)

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.

Procedure: Circum-psoas Block

Sham block

PLACEBO COMPARATOR

Perform ultrasound scanning without puncture.

Procedure: Sham block

Interventions

Circum-psoas Block PROCEDURE

Ultrasound-guided circum-psoas block with 40 mL of treatment drug (Ropivacaine 0.2% \[local anesthetic\]) 30 minutes prior to induction of anesthesia.

Ultrasound guided circum-psoas block

Sham block PROCEDURE

Perform ultrasound scanning without puncture.

Sham block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary unilateral ambulatory hip arthroscopy
• Age 18 to 70 years
• ASA physical status I to III
• Ability to follow the protocol.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Related Publications (3)

• 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.

  PMID: 28003068 BACKGROUND

• Baker 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.

  PMID: 21698591 BACKGROUND

• Zheng 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.

  PMID: 38026457 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ning Li, Doctor

  The Second Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Ning Li, Doctor

CONTACT

86+13791036442; lining252252@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: March 29, 2024
• Study Start: December 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share