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Clinical Trials/NCT00131170
NCT00131170CompletedPhase 4

Paravertebral Block for Breast Surgery

University of Aarhus2 sites in 1 country90 target enrollmentStarted: September 2005Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
90
Locations
2
Primary Endpoint
Nausea and vomiting 2 hours postoperatively, and 1 and 2 days postoperatively

Study Overview

Brief Summary

The effect of paravertebral block in combination with general anaesthesia is studied in a double blind fashion.

Detailed Description

Patients having surgery for breast cancer receive a paravertebral blockade at C8-Th4 with either Naropin 0.5% or saline. General anaesthesia is then provided with laryngeal mask intubation, propofol infusion and fentanyl i.v. as needed. The effect on postoperative pain ([VAS] and fentanyl PCA doses taken) and postoperative nausea and vomiting is recorded.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Breast surgery

Exclusion Criteria

  • Infections
  • Coagulation disorder

Outcomes

Primary Outcomes

Nausea and vomiting 2 hours postoperatively, and 1 and 2 days postoperatively

Time Frame: 2 days

Secondary Outcomes

  • Dosage of analgesic(1 day)

Investigators

Sponsor Class
Other

Study Sites (2)

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