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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-11-30

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.

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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.

Conditions

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Anesthesia, Local Shoulder Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

2 ml 0.9% saline (placebo)

ropivacaine

Intervention Type DRUG

30 ml 0.5% ropivacaine

Group 2

Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

2 ml 0.9% saline (placebo)

Bupivacaine

Intervention Type DRUG

30 ml 0.5% bupivacaine

Group 3

Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml)

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

dexamethasone 8 mg (2 ml)

ropivacaine

Intervention Type DRUG

30 ml 0.5% ropivacaine

Group 4

Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml).

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

dexamethasone 8 mg (2 ml)

Bupivacaine

Intervention Type DRUG

30 ml 0.5% bupivacaine

Interventions

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saline

2 ml 0.9% saline (placebo)

Intervention Type DRUG

Dexamethasone

dexamethasone 8 mg (2 ml)

Intervention Type DRUG

ropivacaine

30 ml 0.5% ropivacaine

Intervention Type DRUG

Bupivacaine

30 ml 0.5% bupivacaine

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No