The Addition of Sufentanil Interscalene Block in Shoulder Surgery

Phase 3

Completed

• Conditions: Postoperative Pain; Shoulder Surgery
• Interventions: Drug: Naropin 0.1% cum sufentanil

• Registration Number: NCT01025102
• Lead Sponsor: Bent Gymoese Jorgensen

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Study Start: 2010-01
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-30
• Last Update Posted: 2013-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naropin 0.1%	Naropin 0.1% cum sufentanil	-

Primary Outcome Measures

Name	Time	Method
Time to experience of moderate to severe postoperative pain	On day of surgery and 1., 2. and 3. postop. day

Secondary Outcome Measures

Name	Time	Method
Side effects	On day of surgery and 1., 2. and. 3. postop. day

Trial Locations

Locations (1)

Anesthetic Clinic, Frederiksberg University Hospital; 🇩🇰 Frederiksberg, Denmark