CPB for Arthroscopic Hip Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Pain; Opioid Use
• Intervention / Treatment: Procedure: Circum-psoas Block; Procedure: Sham block

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ning Li, Doctor; Phone Number: 86+13791036442; Email: lining252252@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided circum-psoas block; 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; Ultrasound-guided circum-psoas block with 40 mL of treatment drug (Ropivacaine 0.2% [local anesthetic]) 30 minutes prior to induction of anesthesia.
Placebo Comparator: Sham block; Perform ultrasound scanning without puncture.	Procedure: Sham block; Perform ultrasound scanning without puncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Postoperative opioid consumption	Cumulative 24-hr postoperative opioid consumption	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).	1, 6, 24 hours postoperatively

Collaborators and Investigators

• Sponsor: The Second Hospital of Shandong University
• Investigators: Study Director: Ning Li, Doctor, The Second Hospital of Shandong University

Publications and helpful links

General 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. Erratum In: Arthroscopy. 2018 Jan;34(1):348. doi: 10.1016/j.arthro.2017.10.031.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: March 24, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: Circum-Psoas Block LN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No