Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament (ACL) Tear; Arthroscopic Anterior Cruciate Ligament Reconstruction
• Interventions: Combination Product: Periarticular injection

• Registration Number: NCT06630520
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

In this prospective, assessor-blinded, single-surgeon clinical trial, the goal was to validate the efficacy of PAI in aACLR surgery with a reduced opioid dose, while achieving similar pain relief with few adverse events. 300 patients who had undergone aACLR were randomly allocated to receive either a PAI or nPAI group. The primary outcome parameters were visual analogue scale (VAS) scores and cumulative morphine dose, through time. Secondary outcome parameters included drug-related adverse events.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-03-20
• Primary Completion: 2022-06-20
• Study Completion: 2023-06-20
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• 1. Patients 18 years or older who had undergone a-ACLR with or without meniscus procedure for anterolateral instability of the knee; 2) agree to participate in this study and to be randomly allocated to either or peri-articular injection protocol and have signed an informed consent.

Exclusion Criteria

• 1. patients with other concomitant injuries such as other ligamentous injury or fracture; 2) Allergy to any of the medication used in either protocol; 3) patient with history of the chronic pain 4) preoperative chronic opioid-dependent patients (exceeding 50 mg oral morphine equivalence per day at time of recruitment); 5) refuse to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periarticular injection	Periarticular injection	-

Primary Outcome Measures

Name	Time	Method
VAS scores	at different time points (postoperative 4,8,24-hour, before discharge) after surgery

Secondary Outcome Measures

Name	Time	Method
cumulative morphine consumption (mg)	at post-operative 4, 8, 24-hour and before discharge

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan