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Pain Management of ACL Reconstruction

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adductor Canal Nerve Block
Ropivacaine injection
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring ACL

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adductor Canal Nerve Block

No Nerve Block

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Immediate Post-op Pain Score
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
Aggregated amount of narcotic medication used, measured in milligrams

Secondary Outcome Measures

Short-term Knee Function 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
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
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
Amount of time, measured in minutes, participants required in PACU before discharge due to pain control

Full Information

First Posted
November 27, 2017
Last Updated
May 9, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03365908
Brief Title
Pain Management of ACL Reconstruction
Official Title
Pain Management of Anterior Cruciate Ligament Reconstruction: Evaluation of Adductor Canal Block Versus Oral Pain Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
ACL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Operating surgeon and outcome assessor will be blind to whether patient had nerve block prior to OR.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adductor Canal Nerve Block
Arm Type
Experimental
Arm Description
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.
Arm Title
No Nerve Block
Arm Type
No Intervention
Arm Description
Participant will receive pre-op oral medications but no nerve block prior to OR for ACL reconstruction.
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Nerve Block
Intervention Description
An adductor canal nerve block with 15 mL of 0.5% ropivacaine will be performed pre-operatively by Anesthesiology.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
15 mL of 0.5% ropivacaine will be administered for the adductor canal block
Primary Outcome Measure Information:
Title
Immediate Post-op Pain Score
Description
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
Time Frame
15 min post-op
Title
Opioid Use
Description
Aggregated amount of narcotic medication used, measured in milligrams
Time Frame
6 weeks post-op
Secondary Outcome Measure Information:
Title
Short-term Knee Function Post-op
Description
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
Time Frame
6 weeks post-op
Title
Intermediate-term Knee Function
Description
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
Time Frame
12 weeks post-op
Title
Long-term Knee Function
Description
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
Time Frame
24 weeks post-op
Title
Post-anaesthesia care unit (PACU) Time
Description
Amount of time, measured in minutes, participants required in PACU before discharge due to pain control
Time Frame
Immediately after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassandra Lee, MD
Organizational Affiliation
UC-Davis Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
85917
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9672915
Citation
Aronowitz ER, Kleinbart FA. Outpatient ACL reconstruction using intraoperative local analgesia and oral postoperative pain medication. Orthopedics. 1998 Jul;21(7):781-4. doi: 10.3928/0147-7447-19980701-07.
Results Reference
background
PubMed Identifier
23241723
Citation
Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
Results Reference
background
PubMed Identifier
26938989
Citation
Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.
Results Reference
background
Links:
URL
https://studypages.com/s/pain-management-after-acl-reconstruction-surgery-952138/
Description
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Pain Management of ACL Reconstruction

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