Anterior Cruciate Ligament Pain Study

Phase 4

Completed

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Drug: Ropivacaine 0.5%; Drug: Percocet 7.5/325; Drug: Naprosyn 500 mg

• Registration Number: NCT02604550
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-11
• Study First Posted: 2015-11-13
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-04
• Results First Submitted: 2017-04-21
• Results First Submitted QC: 2017-04-21
• Last Update Submitted: 2017-04-21
• Results First Posted: 2017-05-31
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adductor Canal Block	Ropivacaine 0.5%	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.
Adductor Canal Block	Percocet 7.5/325	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.
Femoral Nerve Block	Naprosyn 500 mg	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.
Femoral Nerve Block	Percocet 7.5/325	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.
Femoral Nerve Block	Ropivacaine 0.5%	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.
Adductor Canal Block	Naprosyn 500 mg	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.

Primary Outcome Measures

Name	Time	Method
Pain Score	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

Name	Time	Method
Patient-Reported Vomiting	Post-Surgery (up to 6 days)	Total occurrences of patient-reported vomiting post-surgery.
Number of Percocet Tablets Consumed	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,
Patient-Reported Nausea	Post-Surgery (up to 6 days)	Total occurrences of patient-reported nausea post-surgery.
Patient-Reported Itching	Post-Surgery (up to 6 days)	Total occurrences of patient-reported itching post-surgery.
Total Hours of Sleep	First Postoperative Night (up to 12 hours)	The total hours of sleep first postoperative night, between 0 to 12 hours.
Patient-Reported Constipation	Post-Surgery (up to 6 days)	Total occurrences of patient-reported constipation post-surgery.
Patient-Reported Sedation	Post-Surgery (up to 6 days)	Total occurrences of patient-reported feelings of sedation post-surgery.
Time to Straight Less Raise	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.
Percent of Patients Rating Their Satisfaction as "Excellent" or "Good"	2 Weeks Post-Surgery	Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.

Trial Locations

Locations (1)

Emory Healthcare Orthopaedics and Spine Center; 🇺🇸 Atlanta, Georgia, United States