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Clinical Trials/EUCTR2011-002867-40-IE
EUCTR2011-002867-40-IE
Active, not recruiting
Not Applicable

Comparsion of continuous paravertebral blockade and continuous wound catheter infiltration for analgesia following mastectomy.

Department of Anaesthesia0 sitesAugust 5, 2011
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ConditionsThis study will involve the administration of levobupivicaine 0.125% and 0.25%, a local anaesthetic agent licensed for this purpose into the paravertebral space and into the surgical wound, to provide postoperative analgesia for adults having a mastecomy. We aim to compare the analgesia efficacy of paravertebral blockade with surgical wound blockade for post operative pain in the first 48 hours.MedDRA version: 14.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsChirocaine

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
This study will involve the administration of levobupivicaine 0.125% and 0.25%, a local anaesthetic agent licensed for this purpose into the paravertebral space and into the surgical wound, to provide postoperative analgesia for adults having a mastecomy. We aim to compare the analgesia efficacy of paravertebral blockade with surgical wound blockade for post operative pain in the first 48 hours.
Sponsor
Department of Anaesthesia
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 5, 2011
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Adults (aged 18\-80\) presenting for elective mastectomy \+ axillary surgery
  • •Written informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 45
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 45

Exclusion Criteria

  • •Patient refusal
  • •Local infection at site of insertion
  • •Allergy to amide local anaesthetics, fentanyl, morphine, paracetamol, volatile anaesthetics
  • •Concurrent use of MAOIs or within 2 weeks of MAOI use
  • •Systemic anticoagulation or coagulopathy
  • •Uncontrolled hypertension
  • •Uncontrolled Diabetes Mellitus
  • •Severe liver or cardiac dysfunction
  • •Inability to comprehend pain scoring system

Outcomes

Primary Outcomes

Not specified

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