Pain Management of ACL Reconstruction

November 24, 2025 updated by: University of California, Davis

Pain Management of Anterior Cruciate Ligament Reconstruction: Evaluation of Adductor Canal Block Versus Oral Pain Regimen

This study will compare the outcome of pain interventions that are considered standard of care during the surgical treatment of ACL injuries. The comparison will be looking at pain control during and after ACL surgery as well as functional outcomes in patients that had a nerve block versus those who did not. The investigators hypothesize that pain control will be equal between both groups.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Specific Aim #1: To determine if there is a difference in opioid pain medication use following anterior cruciate ligament (ACL) reconstruction between an oral pain regimen versus adductor canal block.

Specific Aim #2: To determine if there is a difference in knee recovery and function post-operatively following ACL reconstruction between an oral pain regimen versus adductor canal block.

Specific Aim #3: To determine if cost-effectiveness or patient flow logistics of ACL reconstruction are affected by whether has patient has adductor canal block versus receiving oral pain medication regimen.

Specific Aim #4: To determine if pre-operative Resiliency scores are associated with post-operative pain and outcomes following ACL reconstruction.

Hypothesis #1: There is no difference in post-operative pain management or functional outcomes following ACL reconstruction based on whether patient had adductor canal block versus an oral pain medication regiment implemented.

Hypothesis #2: Worse resiliency scores pre-operatively are associated with worse outcomes and pain scores post-operatively following ACL reconstruction.

Upon enrollment and at at the participant's pre-op appointment, the participant will complete a questionnaire entitled the Brief Resiliency Scale (BRS) to determine the participant's resiliency score and receive post-operative pain medication prescriptions. At time of surgery the participant will begin a pain diary to chronicle use of pain medication for 6 weeks and turn this document in at the 6-week follow-up appointment along with documentation of time to first able to walk (ambulate) without assistive device (i.e. crutch, walker, etc.). In the recovery room, the participant will verbally complete a Visual Analog Scale to determine the pain level at 15 minutes after surgery and before discharge. At the 3-month post-op visit, the participant will complete another questionnaire entitled the Knee Injury and Osteoarthritis Outcome Score (KOOS) to determine operative knee pain and function. At the 6-month post-op visit, the participant will complete a questionnaire entitled Marx Activity Rating Scale to determine operative knee function.

The treatment will be chosen by chance, like flipping a coin. Neither the participant nor the study doctor will choose what treatment the participant receives. The participant will have a one in two chance of being given each treatment. The participant will know which treatment was given but the operating surgeon will not know.

The participant will be randomized to 1 of 2 standard of care treatment groups at the time of surgery:

  • Adductor canal nerve block (an anesthetic block of the femoral nerve halfway down the thigh that causes numbness in the knee and lower part of the leg)), or
  • No nerve block for perioperative (during the operation) pain control.

Regardless of treatment group, all participants pre-operatively will receive the following pain medication: 400 mg celecoxib (Celebrex), 300 mg gabapentin (Neurontin), and 1 g of acetaminophen (Tylenol) 1-2 hours before surgery. This oral regimen is similar to standard of care pre-operative medication in total knee arthroplasties (knee replacements).

All participants will also receive the same post-operative prescriptions at their pre-operative clinic visit which will be: 90 tablets of 1 g acetaminophen to be taken three times a day for 30 days and 90 tablets of 5 mg oxycodone with 1-2 tablets to be taken every 4 to 6 hours as needed for pain. Additionally, the participant will receive two medications (Zofran, Phenergan) for nausea/vomiting which are to be taken as needed. Participants will record their medication use.

ACL reconstruction and any other procedures to address any other damage in the participants's knee as determined by the surgeon will be performed as per standard clinical practice at an outpatient surgical facility. The participant will undergo standard post-operative rehabilitation. During the standard of care post-operative visits in the Sports Medicine Clinic, the participant will be asked to fill out questionnaires specific for our data collection.

Study Type

Interventional

Enrollment (Estimated)

60

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

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Health

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 to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between the ages of 18 and 45 years old.
  • Clinical and/or advanced imaging confirmation of ACL tear of which reconstructive surgery is recommended and accepted.

Exclusion Criteria:

  • No prior surgery of the affected and contralateral knee
  • Adults unable to consent
  • Children (age < 18 years old)
  • Prisoners
  • Pregnant women
  • Inflammatory arthritis
  • Non-English-speaking patients

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
Experimental: Adductor Canal Nerve Block
Participant will receive an adductor canal nerve block via 15 mL 0.5% ropivacaine injection prior to OR for ACL reconstruction. Participant will receive pre-op oral medications.
Procedure: Adductor Canal Nerve Block
An adductor canal nerve block with 15 mL of 0.5% ropivacaine will be performed pre-operatively by Anesthesiology.
Drug: Ropivacaine injection
15 mL of 0.5% ropivacaine will be administered for the adductor canal block
No Intervention: No Nerve Block
Participant will receive pre-op oral medications but no nerve block prior to OR for ACL reconstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate Post-op Pain Score
Time Frame: 15 min post-op
Measured via Visual Analog Scale (VAS) in recovery, scale from 0 (least) to 10 (maximum), no units, with 0 being no pain and 10 being extreme pain
15 min post-op
Opioid Use
Time Frame: 6 weeks post-op
Aggregated amount of narcotic medication used, measured in milligrams
6 weeks post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term Knee Function Post-op
Time Frame: 6 weeks post-op
Functional recovery of knee following surgery as measured by Knee Injury and Osteoarthritis Outcome Score (no units), range from 0 - 100 with 0 representing extreme problems with the knee and 100 representing no problems
6 weeks post-op
Intermediate-term Knee Function
Time Frame: 12 weeks post-op
Functional recovery of knee following surgery as measured by Marx activity score (no unit), 0 - 16, with 0 representing significant limitation in activity due to knee and 16 representing no limitations
12 weeks post-op
Long-term Knee Function
Time Frame: 24 weeks post-op
Functional recovery of knee following surgery as measured by Tegner activity score (no units), range from 0 - 10, with 0 representing inability to work or perform daily activities due to knee and 10 representing ability to compete in high-level activities
24 weeks post-op
Post-anaesthesia care unit (PACU) Time
Time Frame: Immediately after surgery
Amount of time, measured in minutes, participants required in PACU before discharge due to pain control
Immediately after surgery

Collaborators and Investigators

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

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Cassandra Lee, MD, UC-Davis Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

October 9, 2017

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 7, 2017

Study Record Updates

Last Update Posted (Estimated)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1115203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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