The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine

Conditions
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Anesthesia, Local, Shoulder Surgery

Intervention / Treatment
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* Drug: saline
* Drug: Dexamethasone
* Drug: ropivacaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 years Patients undergoing shoulder procedures, such as rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block | Drug: saline<br>* 2 ml 0.9% saline (placebo)<br>Drug: ropivacaine<br>* 30 ml 0.5% ropivacaine<br>|
| Placebo Comparator: Group 2<br>Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline | Drug: saline<br>* 2 ml 0.9% saline (placebo)<br>Drug: Bupivacaine<br>* 30 ml 0.5% bupivacaine<br>|
| Active Comparator: Group 3<br>Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml) | Drug: Dexamethasone<br>* dexamethasone 8 mg (2 ml)<br>Drug: ropivacaine<br>* 30 ml 0.5% ropivacaine<br>|
| Active Comparator: Group 4<br>Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml). | Drug: Dexamethasone<br>* dexamethasone 8 mg (2 ml)<br>Drug: Bupivacaine<br>* 30 ml 0.5% bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Report of Pain |  | 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 indicatesno pain at all and ten indicates worst pain imaginable. , The higher of the score, the worse of the pain. | Postoperative day 1, 2 and 3 | 
| Total Three-day Opioid Consumption in Oral Oxycodone Equivalent |  | Postoperative day 1, 2 and 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ropivacaine, bupivacaine, glucocorticoid