Anterior Cruciate Ligament Pain Study

NCT02604550 | Completed Phase 4 Results

• 1 other identifier: IRB00083740
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

• Pain Score

  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 Outcomes (9)

• Number of Percocet Tablets Consumed

  Post surgery, Day 0 to Day 6

• Total Hours of Sleep

  First Postoperative Night (up to 12 hours)

• Patient-Reported Nausea

  Post-Surgery (up to 6 days)

• Patient-Reported Vomiting

  Post-Surgery (up to 6 days)

• Patient-Reported Constipation

  Post-Surgery (up to 6 days)

Study Arms (2)

Femoral Nerve Block

ACTIVE COMPARATOR

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%; Drug: Percocet 7.5/325; Drug: Naprosyn 500 mg

Adductor Canal Block

ACTIVE COMPARATOR

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%; Drug: Percocet 7.5/325; Drug: Naprosyn 500 mg

Interventions

Ropivacaine 0.5% DRUG

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

Adductor Canal Block; Femoral Nerve Block

Percocet 7.5/325 DRUG

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

Adductor Canal Block; Femoral Nerve Block

Naprosyn 500 mg DRUG

Naprosyn 500 mg will be taken twice daily.

Adductor Canal Block; Femoral Nerve Block

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Healthcare Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Interventions

oxycodone-acetaminophen; Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

Data collection with a paper journal was low, resulting in the study switching to a smartphone application for participant record keeping. The data analyses include participants who enrolled after the smartphone application became available.

Results Point of Contact

• Title: John Xerogeanes, MD
• Organization: Emory University

jxeroge@emory.edu

404-778-7202

Study Officials

• John Xerogeanes, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 13, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 31, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-04

Locations

US (1)