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

This study is currently recruiting participants.
Verified February 2013 by Hospital for Special Surgery, New York
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01586806
First received: April 25, 2012
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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 2 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.


Condition Intervention Phase
Anterior Cruciate Ligament Reconstruction
Regional Anesthesia, Saphenous Nerve Block
 Drug: Bupivacaine Only
Drug: Bupivacaine with 2 ml of Dexamethasone
Drug: Bupivacaine with 4 mg of Dexamethasone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Patient-perceived duration of analgesia [ Time Frame: Up to 2 days following surgery ] [ Designated as safety issue: No ]
    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: Up to 14 days following surgery ] [ Designated as safety issue: No ]
    Patients will be called on postoperative days 1, 2 and 14 and asked to rate, on a scale of 0-10, their pain while at rest and when moving.

  • Patient Satisfaction [ Time Frame: Up to 2 days following surgery ] [ Designated as safety issue: No ]

    Patient satisfaction with their analgesia experience will be rated in two ways:

    1. During phone interview on postoperative days 1 and 2, patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);
    2. During phone interview on postoperative days 1 and 2, data collector will record patient responses to the Short Form 8 Health Survey questions on patient satisfaction.

  • Postoperative Morphine Consumption [ Time Frame: Up to 2 days following surgery ] [ Designated as safety issue: No ]
    During phone interview on postoperative days 1 and 2, data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.

  • Opioid-Related Side Effects [ Time Frame: Up to 2 days following surgery ] [ Designated as safety issue: No ]
    During phone interview on postoperative days 1 and 2, data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. nausea, vomiting, itching).


Estimated Enrollment: 195
Study Start Date: July 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 2 mg Drug: Bupivacaine with 2 ml 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 2 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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586806

Contacts
Contact: Tzipora Kuba, PhD 212-774-7154 kubat@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Principal Investigator: Mary F. Chisholm, MD            
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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:

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01586806     History of Changes
Other Study ID Numbers: IRB #2012-002
Study First Received: April 25, 2012
Last Updated: February 7, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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:
Anesthetics, Local
Bupivacaine
Anesthetics
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
 Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013