Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery

NCT06630520 | Completed DMC

• 1 other identifier: 2022-05-004B
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

periarticular injection; morphine consumption; pain control

Outcome Measures

Primary Outcomes (1)

• VAS scores

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

Secondary Outcomes (1)

• cumulative morphine consumption (mg)

  at post-operative 4, 8, 24-hour and before discharge

Other Outcomes (2)

• drug related adverse events

  within postoperative 2 weeks

• overall satisfaction scale (0-100 points)

  at postoperative 2 weeks

Study Arms (2)

Periarticular injection

ACTIVE COMPARATOR

Combination Product: Periarticular injection

Control group

NO INTERVENTION

Interventions

Periarticular injection COMBINATION_PRODUCT

A 50ml periarticular injection was introduced intraoperatively before the time of closing. The injection contained 150mg bupivacaine (3mg/mL), 60mg ketorolac(1.2mg/mL) and 1mg morphine. Before wound closure, periarticular cocktail was injected around the knee joint including the adductor canal from the hamstring harvest side in PAI group. All patients had oral paracetamol 500mg, 4 times/day and diclofenac 75mg, 1 times/day after surgery.

Periarticular injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan, 112, Taiwan

Location

MeSH Terms

Conditions

Lacerations; Agnosia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: March 20, 2022
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2023
• Last Updated: October 8, 2024

Record last verified: 2022-02

Locations

TW (1)