CompletedNot Applicable

Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery

Taiwan288 participantsStarted 2022-03-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

VAS scores

Timeframe: at different time points (postoperative 4,8,24-hour, before discharge) after surgery

Trial details

NCT IDNCT06630520

SponsorTaipei Veterans General Hospital, Taiwan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-06-20

View on ClinicalTrials.gov More Anterior Cruciate Ligament (ACL) Tear trials