Phase 4
N=195
Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction · Regional Anesthesia, Saphenous Nerve Block
Bottom Line
View on ClinicalTrials.gov: NCT01586806 ↗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
| Outcome | Result | p-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).
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.