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

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ClinicalTrials.gov Identifier: NCT01586806

Recruitment Status : Completed

First Posted : April 27, 2012

Results First Posted : June 9, 2016

Last Update Posted : November 28, 2016

Sponsor:

Information provided by (Responsible Party):

Hospital for Special Surgery, New York

Study Description

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:

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.

Condition or disease	Intervention/treatment	Phase
Anterior Cruciate Ligament Reconstruction Regional Anesthesia, Saphenous Nerve Block	Drug: Bupivacaine Only Drug: Bupivacaine with 1 mg of Dexamethasone Drug: Bupivacaine with 4 mg of Dexamethasone	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	195 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction
Study Start Date :	July 2012
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Injuries and Disorders Non-Drug Pain Management Plastic and Cosmetic Surgery

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Control	Drug: Bupivacaine Only This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
Active Comparator: Dexamethasone 1 mg	Drug: Bupivacaine with 1 mg of Dexamethasone This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
Active Comparator: Dexamethasone 4 mg	Drug: Bupivacaine with 4 mg of Dexamethasone This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.

Outcome Measures

Primary Outcome Measures :

Patient-perceived Duration of Analgesia [ Time Frame: Up to 2 days following surgery ]
After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.

Secondary Outcome Measures :

NRS (Numerical Rating Scale) Pain Scores [ Time Frame: Postoperative day 1 ]
Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.
Patient Satisfaction [ Time Frame: Up to 2 days following surgery ]
Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);
Postoperative Morphine Consumption [ Time Frame: Up to 2 days following surgery ]
Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.
Opioid-Related Side Effects (Drowsiness) [ Time Frame: Up to 2 days following surgery ]
Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.

Eligibility Criteria

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Ages Eligible for Study:	16 Years to 65 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586806

Locations

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

Sponsors and Collaborators

Hospital for Special Surgery, New York

Investigators

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Principal Investigator:	Mary F. Chisholm, MD	Hospital for Special Surgery, New York

More Information

Additional Information:

This is the link to Hospital for Special Surgery website. This link exits the ClinicalTrials.gov site

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. doi: 10.1213/01.ANE.0000133143.60584.38.

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.

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Responsible Party:	Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:	NCT01586806
Other Study ID Numbers:	IRB #2012-002
First Posted:	April 27, 2012 Key Record Dates
Results First Posted:	June 9, 2016
Last Update Posted:	November 28, 2016
Last Verified:	August 2016

Keywords provided by Hospital for Special Surgery, New York:


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)

Additional relevant MeSH terms:

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Dexamethasone Dexamethasone acetate Bupivacaine BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents

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