Pain Management of ACL Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2026-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Operating surgeon and outcome assessor will be blind to whether patient had nerve block prior to OR.

Study Groups

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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.

Group Type EXPERIMENTAL

Adductor Canal Nerve Block

Intervention Type PROCEDURE

An adductor canal nerve block with 15 mL of 0.5% ropivacaine will be performed pre-operatively by Anesthesiology.

Ropivacaine injection

Intervention Type DRUG

15 mL of 0.5% ropivacaine will be administered for the adductor canal block

No Nerve Block

Participant will receive pre-op oral medications but no nerve block prior to OR for ACL reconstruction.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adductor Canal Nerve Block

An adductor canal nerve block with 15 mL of 0.5% ropivacaine will be performed pre-operatively by Anesthesiology.

Intervention Type PROCEDURE

Ropivacaine injection

15 mL of 0.5% ropivacaine will be administered for the adductor canal block

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No