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Completed

NCT Number: NCT01025102

The Addition of Sufentanil Interscalene Block in Shoulder Surgery

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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shoulder Surgery Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anesthetic Clinic, Frederiksberg University Hospital

Frederiksberg, 2000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naropin 0.1% cum sufentanil

Drug

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

Other names: Local analgetic, Ropivacain

Primary outcomes

  1. Time to experience of moderate to severe postoperative pain

    Time frame: On day of surgery and 1., 2. and 3. postop. day

Secondary outcomes

  1. Side effects

    Time frame: On day of surgery and 1., 2. and. 3. postop. day

Sponsors and collaborators

Lead sponsor

Bent Gymoese Jorgensen

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2009
Registry last updated
Apr 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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