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

October 4, 2024 updated by: En-Rung Chiang, Taipei Veterans General Hospital, Taiwan

Intraoperative Periarticular Injection May Improve Postoperative Pain Scores and Reduce Opioid Consumption in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Active Comparator: Periarticular injection
Combination product: Periarticular injection

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS scores
Time Frame: at different time points (postoperative 4,8,24-hour, before discharge) after surgery
at different time points (postoperative 4,8,24-hour, before discharge) after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
cumulative morphine consumption (mg)
Time Frame: at post-operative 4, 8, 24-hour and before discharge
at post-operative 4, 8, 24-hour and before discharge

Other Outcome Measures

Outcome Measure
Time Frame
drug related adverse events
Time Frame: within postoperative 2 weeks
within postoperative 2 weeks
overall satisfaction scale (0-100 points)
Time Frame: at postoperative 2 weeks
at postoperative 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2022

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-05-004B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Concerning the patient's privacy

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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