The Addition of Sufentanil Interscalene Block in Shoulder Surgery

Postoperative Pain Clinical Trial

Official title:

Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025102
• Other study ID #: gymoese007
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2009
• Last updated: March 30, 2013
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Shoulder Surgery

Intervention

Drug:
• Naropin 0.1% cum sufentanil
20ml of Naropin 0.1% cum sufentanil 1mikrog per ml

Locations

Country	Name	City	State
Denmark	Anesthetic Clinic, Frederiksberg University Hospital	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Bent Gymoese Jorgensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to experience of moderate to severe postoperative pain		On day of surgery and 1., 2. and 3. postop. day	Yes
Secondary	Side effects		On day of surgery and 1., 2. and. 3. postop. day	Yes