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Anterior Cruciate Ligament Pain Study

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ClinicalTrials.gov Identifier: NCT02604550
Recruitment Status : Completed
First Posted : November 13, 2015
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
John Xerogeanes, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Drug: Ropivacaine 0.5% Drug: Percocet 7.5/325 Drug: Naprosyn 500 mg Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
Study Start Date : November 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02604550


Locations
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United States, Georgia
Emory Healthcare Orthopaedics and Spine Center
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: John Xerogeanes, MD Emory University

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Responsible Party: John Xerogeanes, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02604550     History of Changes
Other Study ID Numbers: IRB00083740
First Posted: November 13, 2015    Key Record Dates
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Acetaminophen
Acetaminophen, hydrocodone drug combination
Naproxen
Oxycodone
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antipyretics
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action