Risk Factors for Post ACL Reconstruction Pain

September 5, 2022 updated by: Sasikaan Nimmaanrat, Prince of Songkla University

Risk Factors for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction

In 2006, approximately 130,000 arthroscopic anterior cruciate ligament reconstructions were performed in the United States, and the number is increasing each year. Despite being a minimally invasive procedure, pain is the most common postoperative problem after arthroscopic anterior cruciate ligament reconstruction associated with cost, postoperative opioid consumption, opioid-related side effects, quality of life, patient satisfaction, and delayed discharge. Over two-thirds of the patient receiving arthroscopic anterior cruciate ligament surgery have moderate to severe pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

At present, multimodal analgesia is a successful mainstay treatment for arthroscopic anterior cruciate ligament surgery which range from opioid, paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), local anesthetic agents, ketamine, corticosteroid, and cold compression therapy. Previous study showed femoral nerve block reduces pain score but also increases incidence of falling. Afterward, a study on adductor canal block showed equivalent postoperative analgesia while preserving quadriceps strength. Furthermore, a few studies were conducted to determine risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery, but results are contradictory. Previous research found risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery are female, young age, smoker, preoperative visual analog scale score ≥3, tourniquet time > 50 minutes, and cartilage injury. In addition, evidence showed higher preoperative visual analog scale, and previous opioid use are associated with greater amount of opioid consumption. In contrary, some evidence showed no effect of age, sex, body mass index (BMI), tourniquet time, type of anesthesia on post postoperative pain after arthroscopic anterior cruciate ligament surgery.

Study Type

Observational

Enrollment (Anticipated)

924

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing primary unilateral arthroscopic anterior cruciate ligament reconstruction with or without unilateral cartilage/meniscus injury with or without other ligaments injury (posterior cruciate ligament/medial collateral ligament/lateral collateral ligament)

Description

Patients undergoing primary unilateral arthroscopic anterior cruciate ligament reconstruction with or without unilateral cartilage/meniscus injury with or without other ligaments injury (posterior cruciate ligament/medial collateral ligament/lateral collateral ligament) Age ≥ 15 years

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To find risk factors for moderate to severe postoperative pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours.
Time Frame: Three days
To find risk factors for moderate to severe postoperative pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours
Three days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To find incidence of moderate to severe pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours
Time Frame: Three days
To find incidence of moderate to severe pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours
Three days
To find analgesic requirement after arthroscopic anterior cruciate ligament reconstruction for 1 year
Time Frame: One year after discharge
To find analgesic requirement after arthroscopic anterior cruciate ligament reconstruction for 1 year
One year after discharge

Collaborators and Investigators

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

Sponsor

Prince of Songkla University

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 (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • REC.65-319-8-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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