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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
218
2 ml 0.9% saline (placebo)
dexamethasone 8 mg (2 ml)
30 ml 0.5% ropivacaine
Cleveland Clinic
Cleveland, Ohio, United States
The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block
Time frame: Postoperative day 1, 2 and 3
Time to First Report of Pain
Time frame: Postoperative day 1, 2 and 3
Median Maximum VAS Pain Scores at Rest
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 frame: Postoperative day 1, 2 and 3
Total Three-day Opioid Consumption in Oral Oxycodone Equivalent
Time frame: Postoperative day 1, 2 and 3
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30 ml 0.5% bupivacaine