Clinical trial NCT01586806: Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Official title: Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Reconstruction
Regional Anesthesia, Saphenous Nerve Block
Keywords: Dexamethasone
Glucocorticoids
Physiological Effects of Drugs
Therapeutic Uses
Anterior Cruciate Ligament Reconstruction
Regional Anesthesia, nerve block
Ultrasonic Imaging
Post-Operative Complications: muscle weakness, pain, nausea and vomiting
Dexamethasone (as local anesthetic additive)
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 195
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Patient-perceived Duration of Analgesia
timeFrame: Up to 2 days following surgery
Secondary outcomes:
measure: NRS (Numerical Rating Scale) Pain Scores
timeFrame: Postoperative day 1
measure: Patient Satisfaction
timeFrame: Up to 2 days following surgery
measure: Postoperative Morphine Consumption
timeFrame: Up to 2 days following surgery
measure: Opioid-Related Side Effects (Drowsiness)
timeFrame: Up to 2 days following surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Mary F. Chisholm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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. doi: 10.1016/0959-8049(94)90182-1.
citation: 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. doi: 10.1213/01.ANE.0000133143.60584.38.
citation: Lundblad M, Kapral S, Marhofer P, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. doi: 10.1093/bja/ael241. Epub 2006 Sep 26.
citation: Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates 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.