The Addition of Sufentanil Interscalene Block in Shoulder Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.

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Detailed Description

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The purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery

Conditions

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Postoperative Pain Shoulder Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Naropin 0.1%

Group Type EXPERIMENTAL

Naropin 0.1% cum sufentanil

Intervention Type DRUG

20ml of Naropin 0.1% cum sufentanil 1mikrog per ml

Interventions

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Naropin 0.1% cum sufentanil

20ml of Naropin 0.1% cum sufentanil 1mikrog per ml

Intervention Type DRUG

Other Intervention Names

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Local analgetic Ropivacain

Eligibility Criteria

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Inclusion Criteria

* ASA I-III
* Age 18-80
* Shoulder surgery performed under interscalene block and general anesthesia

Exclusion Criteria

* Contraindication of interscalene block
* Severe chronic obstructive lung disease
* Non-cooperative patient
* Intolerance to opioids
* Pregnancy
* Rheumatoid arthritis and diabetes with peripheral polyneuropathy
* Chronic pain or daily opioid intake

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No