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Phase 4 N=195 Randomized Double-blind Treatment

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

Anterior Cruciate Ligament Reconstruction · Regional Anesthesia, Saphenous Nerve Block

Enrolled (actual)
195
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Patient-perceived Duration of Analgesia — 33; 41; 46.5 hours

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Bupivacaine Only (Drug); Bupivacaine with 1 mg of Dexamethasone (Drug); Bupivacaine with 4 mg of Dexamethasone (Drug)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
Hospital for Special Surgery, New York
Primary completion
Nov 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient-perceived Duration of Analgesia
33; 41; 46.5
SECONDARY
NRS (Numerical Rating Scale) Pain Scores
3; 3; 2
SECONDARY
Patient Satisfaction
8; 8; 9
SECONDARY
Postoperative Morphine Consumption
45; 30; 30
SECONDARY
Opioid-Related Side Effects (Drowsiness)
1.1; 1; 0

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
  • 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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01586806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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