NCT01586806

Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction

Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia. Depending on the randomized treatment assignment, patients may receive one of the following: 1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone); 2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone; 3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone. Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.

Conditions

• Anterior Cruciate Ligament Reconstruction
• Regional Anesthesia, Saphenous Nerve Block

Interventions

Type	Name	Description
DRUG	Bupivacaine Only	This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
DRUG	Bupivacaine with 1 mg of Dexamethasone	This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
DRUG	Bupivacaine with 4 mg of Dexamethasone	This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2012-04-27
• Last updated: 2016-11-28
• Results posted: 2016-06-09

Locations

1 site across 1 country: United States