Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-01-01 @ 4:11 AM
Study NCT ID:
NCT01586806
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2012-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Sponsor:
Hospital for Special Surgery, New York
Organization:
Study Overview
Official Title:
Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: