Anterior Cruciate Ligament Pain Study

April 21, 2017 updated by: John Xerogeanes, Emory University

Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial

The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial is a prospective, randomized, surgeon-blinded, two-armed trial to investigate the safety and efficacy of femoral nerve blocks versus adductor canal blocks for participants undergoing outpatient anterior cruciate ligament (ACL) reconstruction surgery.

The objective of this study is to compare the pain control benefit of two different types of nerve blocks. Ropivacaine, which is FDA-approved for use in both femoral nerve blocks as well as adductor canal blocks, will be utilized. The study will be comparing the efficacy between FDA approved treatments.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 4

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
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory Healthcare Orthopaedics and Spine Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center
  • Patients willing and able to provide written informed consent
  • Parents willing and able to provide written informed consent for minors

Exclusion Criteria:

  • Patients who are pregnant or lactating
  • Patients with liver dysfunction or renal failure
  • Patients with a known allergy to ropivacaine
  • Patients with a local infection
  • Patients who take chronic pain medications
  • Patients with an opioid tolerance
  • Patients with known coagulopathy or bleeding risk.
  • Patients who are getting neuraxial anesthesia for surgery

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Femoral Nerve Block
Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Drug: Ropivacaine 0.5%
Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.
Drug: Percocet 7.5/325
Percocet 7.5/325 will taken as needed up to every four hours.
Drug: Naprosyn 500 mg
Naprosyn 500 mg will be taken twice daily.
Active Comparator: Adductor Canal Block
Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Drug: Ropivacaine 0.5%
Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.
Drug: Percocet 7.5/325
Percocet 7.5/325 will taken as needed up to every four hours.
Drug: Naprosyn 500 mg
Naprosyn 500 mg will be taken twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: Post-surgery (day of surgery to 6 days post-surgery)
Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.
Post-surgery (day of surgery to 6 days post-surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Percocet Tablets Consumed
Time Frame: Post surgery, Day 0 to Day 6
Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms,
Post surgery, Day 0 to Day 6
Total Hours of Sleep
Time Frame: First Postoperative Night (up to 12 hours)
The total hours of sleep first postoperative night, between 0 to 12 hours.
First Postoperative Night (up to 12 hours)
Patient-Reported Nausea
Time Frame: Post-Surgery (up to 6 days)
Total occurrences of patient-reported nausea post-surgery.
Post-Surgery (up to 6 days)
Patient-Reported Vomiting
Time Frame: Post-Surgery (up to 6 days)
Total occurrences of patient-reported vomiting post-surgery.
Post-Surgery (up to 6 days)
Patient-Reported Constipation
Time Frame: Post-Surgery (up to 6 days)
Total occurrences of patient-reported constipation post-surgery.
Post-Surgery (up to 6 days)
Patient-Reported Sedation
Time Frame: Post-Surgery (up to 6 days)
Total occurrences of patient-reported feelings of sedation post-surgery.
Post-Surgery (up to 6 days)
Patient-Reported Itching
Time Frame: Post-Surgery (up to 6 days)
Total occurrences of patient-reported itching post-surgery.
Post-Surgery (up to 6 days)
Time to Straight Less Raise
Time Frame: Post-Surgery (up to 6 days)
The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery.
Post-Surgery (up to 6 days)
Percent of Patients Rating Their Satisfaction as "Excellent" or "Good"
Time Frame: 2 Weeks Post-Surgery
Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.
2 Weeks Post-Surgery

Collaborators and Investigators

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

Sponsor

Emory University

Investigators

  • Principal Investigator: John Xerogeanes, MD, Emory 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

November 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00083740

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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