CPB for Arthroscopic Hip Surgery

Opioid Use Clinical Trial

Official title:

Circum-Psoas Block for Arthroscopic Hip Surgery: A Randomized, Triple-blind，Placebo Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06337968
• Other study ID #: Circum-Psoas Block LN
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: The Second Hospital of Shandong University
• Contact: Ning Li, Doctor
• Phone: 86+13791036442
• Email: lining252252[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: May 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Pain
• Opioid Use

Intervention

Procedure:
• Circum-psoas Block
Ultrasound-guided circum-psoas block with 40 mL of treatment drug (Ropivacaine 0.2% [local anesthetic]) 30 minutes prior to induction of anesthesia.
• Sham block
Ultrasound-guided injection of equal volume of normal saline in the same location as would for a circum-psoas block.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

References & Publications (3)

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 — View Citation

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. d — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative opioid consumption	Cumulative 24-hr postoperative opioid consumption	up to the first 24 hours postoperatively
Secondary	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).	up to the first 24 hours postoperatively
Secondary	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).	1, 6, 24 hours postoperatively
Secondary	Patient satisfaction	Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)	at the end of 24 hours postoperatively