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

Hospital for Special Surgery (HSS)

Status and phase

Completed

Phase 4

Conditions

Regional Anesthesia, Saphenous Nerve Block

Anterior Cruciate Ligament Reconstruction

Treatments

Drug: Bupivacaine with 1 mg of Dexamethasone

Drug: Bupivacaine with 4 mg of Dexamethasone

Drug: Bupivacaine Only

Study type

Interventional

Funder types

Other

Identifiers

NCT01586806

IRB #2012-002

Details and patient eligibility

About

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:

13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);
13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;
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.

Enrollment

195 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients undergoing ambulatory surgery for anterior cruciate ligament (ACL) reconstruction with a patella tendon autograft.
ASA I-III [American Society of Anesthesiologists (ASA) Physical Status classification system]
BMI < 35
Smokers included
Ages 16-65

Exclusion criteria

Patients on steroids or requiring stress dose steroids
BMI > 35
Patient refusal
Allergy to study medications,
NRS scores > 3 with frequent opioid use (including tramadol) prior to surgery-daily for greater than 3 weeks
Lower extremity neurological dysfunction
Diabetic (NIDDM, insulin-dependent and/or oral hypoglycemic dependent)
Not in included age range (under 16 or over 65 years of age)
Contraindications to the use of dexamethasone
Non-English speaking patients. We will be using the Short Form 8 Health Survey, as well as the OR-SDS questionnaire (these are in English; any translations would have to be separately validated).