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Pain Management of ACL Reconstruction

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03365908
First Posted: December 7, 2017
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
  Purpose
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.

Condition Intervention
Anterior Cruciate Ligament Rupture Procedure: Adductor Canal Nerve Block Drug: Ropivacaine injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Operating surgeon and outcome assessor will be blind to whether patient had nerve block prior to OR.
Primary Purpose: Treatment
Official Title: Pain Management of Anterior Cruciate Ligament Reconstruction: Evaluation of Adductor Canal Block Versus Oral Pain Regimen

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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

  • Opioid Use [ Time Frame: 6 weeks post-op ]
    Aggregated amount of narcotic medication used, measured in milligrams


Secondary Outcome Measures:
  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 60
Actual Study Start Date: October 9, 2017
Estimated Study Completion Date: October 8, 2018
Estimated Primary Completion Date: October 8, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Hide Detailed Description

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365908


Locations
United States, California
UC Davis Health
Sacramento, California, United States, 85917
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Cassandra Lee, MD UC-Davis Health
  More Information

Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03365908     History of Changes
Other Study ID Numbers: 1115203
First Submitted: November 27, 2017
First Posted: December 7, 2017
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by University of California, Davis:
ACL

Additional relevant MeSH terms:
Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents