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

Phase 4
Completed
Conditions
Anterior Cruciate Ligament Reconstruction
Regional Anesthesia, Saphenous Nerve Block
Interventions
Registration Number
NCT01586806
Lead Sponsor
Hospital for Special Surgery, New York
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
195
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlBupivacaine Only-
Dexamethasone 1 mgBupivacaine with 1 mg of Dexamethasone-
Dexamethasone 4 mgBupivacaine with 4 mg of Dexamethasone-
Primary Outcome Measures
NameTimeMethod
Patient-perceived Duration of AnalgesiaUp 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
NameTimeMethod
NRS (Numerical Rating Scale) Pain ScoresPostoperative 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 SatisfactionUp 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 ConsumptionUp 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)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.

Trial Locations

Locations (1)

Hospital for Special Surgery

🇺🇸

New York, New York, United States

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