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



Status:Recruiting
Healthy:No
Age Range:16 - 65
Updated:2/7/2015
Start Date:July 2012
Contact:Tzipora Kuba, PhD
Email:kubat@hss.edu
Phone:212-774-7154

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

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.


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).
We found this trial at
2
sites
535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, NY
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
?
mi
from
New York, NY
Click here to add this to my saved trials