Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
- Conditions
- Anterior Cruciate Ligament ReconstructionRegional 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
- 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
- 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
Group Intervention Description Control Bupivacaine Only - Dexamethasone 1 mg Bupivacaine with 1 mg of Dexamethasone - Dexamethasone 4 mg Bupivacaine with 4 mg of Dexamethasone -
- Primary Outcome Measures
Name Time Method Patient-perceived Duration of Analgesia 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
Name Time Method NRS (Numerical Rating Scale) Pain Scores 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 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 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) 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