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Clinical Trials/ISRCTN46621916
ISRCTN46621916
Completed
未知

A randomised, double blind, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy

Royal Cornwall Hospitals NHS Trust (UK)0 sites160 target enrollmentSeptember 10, 2012
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Royal Cornwall Hospitals NHS Trust (UK)
Enrollment
160
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25270861

Registry
who.int
Start Date
September 10, 2012
End Date
August 14, 2016
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Royal Cornwall Hospitals NHS Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. All women presenting for unilateral mastectomy surgery at the Royal Cornwall Hospitals NHS Trust and Royal Devon and Exeter NHS Foundation Trust
  • •3\. Aged 18 years and over
  • •4\. Scheduled for unilateral mastectomy with or without axillary involvement

Exclusion Criteria

  • •1\. Inability to give informed consent
  • •2\. Primary reconstructive surgery
  • •3\. Hypotension, hypovolaemia or any form of shock
  • •4\. Known allergy or sensitivity to local anaesthetic agents, morphine, paracetamol or ondansetron
  • •5\. Pregnancy
  • •6\. Daily opioid analgesic use
  • •7\. Inability to understand or use a PCA device
  • •8\. Inability to understand or complete the visual analogue assessment tools
  • •9\. Concurrent participation in another interventional study that might conflict with this trial

Outcomes

Primary Outcomes

Not specified

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