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

Information source: Hospital for Special Surgery, New York
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anterior Cruciate Ligament Reconstruction; Regional Anesthesia, Saphenous Nerve Block

Intervention: Bupivacaine Only (Drug); Bupivacaine with 1 mg of Dexamethasone (Drug); Bupivacaine with 4 mg of Dexamethasone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital for Special Surgery, New York

Official(s) and/or principal investigator(s):
Mary F. Chisholm, MD, Principal Investigator, Affiliation: Hospital for Special Surgery, New York

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Patient-perceived duration of analgesia

Secondary outcome:

NRS (numerical rating scale) Pain Scores

Patient Satisfaction

Postoperative Morphine Consumption

Opioid-Related Side Effects

Eligibility

Minimum age: 16 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Hospital for Special Surgery, New York, New York 10021, United States
Additional Information

This is the link to Hospital for Special Surgery website.

Related publications:

Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.

Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.

Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36.

Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004 Sep;99(3):699-709, table of contents.

Lundblad M, Kapral S, Marhofer P, Lönnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. Epub 2006 Sep 26.

Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gümüş H, Ateş Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.

Starting date: July 2012
Last updated: December 19, 2014

Page last updated: August 23, 2015

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