Anterior Cruciate Ligament Pain Study

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604550
• Other study ID #: IRB00083740
• Status: Completed
• Phase: Phase 4
• First received: November 11, 2015
• Last updated: July 8, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Drug:
• Ropivacaine 0.5%
Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.
• Percocet 7.5/325
Percocet 7.5/325 will taken as needed up to every four hours.
• Naprosyn 500 mg
Naprosyn 500 mg will be taken twice daily.

Locations

Country	Name	City	State
United States	Emory Healthcare Orthopaedics and Spine Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain scores will be assessed every four hours for six days.	Post Surgery (Up to 6 days)	No
Secondary	Total Opioid Consumption	Total opioid dose in mg/kg given within 24 hours following surgery.	Post surgery (Up to 24 hours)	No
Secondary	Total Hours of Sleep	The total hours of sleep first postoperative night between 0 to 12 hours.	First Postoperative Night (Up to 12 hours)	No
Secondary	Incidence of Patient-Reported Nausea	Total occurrences of patient-reported nausea post-surgery.	Post-Surgery (Up to 6 days)	No
Secondary	Incidence of Patient-Reported Vomiting	Total occurrences of patient-reported vomiting post-surgery.	Post-Surgery (Up to 6 days)	No
Secondary	Incidence of Patient-Reported Constipation	Total occurrences of patient-reported constipation post-surgery.	Post-Surgery (Up to 6 days)	No
Secondary	Incidence of Patient-Reported Sedation	Total occurrences of patient-reported sedation post-surgery.	Post-Surgery (Up to 6 days)	No
Secondary	Incidence of Patient-Reported Itching	Total occurrences of patient-reported itching post-surgery.	Post-Surgery (Up to 6 days)	No
Secondary	Time to straight less raise	The amount of time it takes post-surgery for participants to have the ability to perform a straight leg raise.	Post-Surgery (Up to 6 days)	No
Secondary	Patient Satisfaction Rating	Patient satisfaction will be reported on a scale of excellent, good, satisfactory, poor two weeks following surgery.	Post Surgery (2 Weeks)	No