Skip to content

The Addition of Sufentanil Interscalene Block in Shoulder Surgery

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01025102
Enrollment
26
Registered
2009-12-03
Start date
2010-01-31
Completion date
2012-12-31
Last updated
2013-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Shoulder Surgery

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

Interventions

DRUGNaropin 0.1% cum sufentanil

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

Sponsors

Bent Gymoese Jorgensen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to experience of moderate to severe postoperative painOn day of surgery and 1., 2. and 3. postop. day

Secondary

MeasureTime frame
Side effectsOn day of surgery and 1., 2. and. 3. postop. day

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026