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Completed

NCT Number: NCT02604550

Anterior Cruciate Ligament Pain Study

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory Healthcare Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine 0.5%

Drug

Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.

Percocet 7.5/325

Drug

Percocet 7.5/325 will taken as needed up to every four hours.

Naprosyn 500 mg

Drug

Naprosyn 500 mg will be taken twice daily.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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,

  2. 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.

  3. Patient-Reported Nausea

    Time frame: Post-Surgery (up to 6 days)

    Total occurrences of patient-reported nausea post-surgery.

  4. Patient-Reported Vomiting

    Time frame: Post-Surgery (up to 6 days)

    Total occurrences of patient-reported vomiting post-surgery.

  5. Patient-Reported Constipation

    Time frame: Post-Surgery (up to 6 days)

    Total occurrences of patient-reported constipation post-surgery.

  6. Patient-Reported Sedation

    Time frame: Post-Surgery (up to 6 days)

    Total occurrences of patient-reported feelings of sedation post-surgery.

  7. Patient-Reported Itching

    Time frame: Post-Surgery (up to 6 days)

    Total occurrences of patient-reported itching post-surgery.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2015
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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