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Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery (PAI in ACLR)

T

Taipei Veterans General Hospital

Status

Completed

Conditions

Anterior Cruciate Ligament (ACL) Tear
Arthroscopic Anterior Cruciate Ligament Reconstruction

Treatments

Combination Product: Periarticular injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06630520
2022-05-004B

Details and patient eligibility

About

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.

Enrollment

288 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

288 participants in 2 patient groups

Periarticular injection
Active Comparator group
Treatment:
Combination Product: Periarticular injection
Control group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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