The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine
- Conditions
- Anesthesia, LocalShoulder Surgery
- Interventions
- Registration Number
- NCT00801138
- Lead Sponsor
- The Cleveland Clinic
- Brief Summary
This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.
- Detailed Description
This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups:
* Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block;
* Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo);
* Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic;
* Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic.
The primary outcome is the duration of the interscalene nerve block which is time to first analgesic request after PACU discharge.
Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 218
- Age between 18 and 75 years
- Patients undergoing shoulder procedures, such as rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression
- Contraindications to interscalene block (Coagulopathy, infection at the needle insertion site, moderate to severe chronic obstructive pulmonary disease, contralateral pneumothorax or diaphragmatic paralysis)
- Pregnancy
- Pre-existing neuropathy involving the surgical limb
- Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery
- Chronic opioid use (greater than 30 mg oral oxycodone equivalent per day)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Group 1 saline Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block Group 2 saline Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline Group 1 ropivacaine Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block Group 2 Bupivacaine Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline Group 4 Dexamethasone Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml). Group 3 ropivacaine Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml) Group 3 Dexamethasone Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml) Group 4 Bupivacaine Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml).
- Primary Outcome Measures
Name Time Method The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block Postoperative day 1, 2 and 3
- Secondary Outcome Measures
Name Time Method Median Maximum VAS Pain Scores at Rest Postoperative day 1, 2 and 3 Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicates"no pain at all" and ten indicates "worst pain imaginable." , The higher of the score, the worse of the pain.
Time to First Report of Pain Postoperative day 1, 2 and 3 Total Three-day Opioid Consumption in Oral Oxycodone Equivalent Postoperative day 1, 2 and 3
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States