EUCTR2019-001016-35-DK
Active, not recruiting
Phase 1
The ultrasound-guided multiple-injection costotransverse block for mastectomy and primary reconstructive surgery. A double blind, randomised, placebo controlled trial.
Associate Professor, Consultant Jens Børglum0 sites36 target enrollmentMarch 14, 2019
ConditionsPostoperative pain following mastectomy and reconstructive surgery due to breast cancer.MedDRA version: 20.0Level: LLTClassification code 10026881Term: Mastectomy radicalSystem Organ Class: 100000004865MedDRA version: 20.0Level: LLTClassification code 10051042Term: Plastic surgery NOSSystem Organ Class: 100000004865MedDRA version: 20.0Level: LLTClassification code 10006188Term: Breast cancer female NOSSystem Organ Class: 100000004864Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsRopivacaine
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Postoperative pain following mastectomy and reconstructive surgery due to breast cancer.
- Sponsor
- Associate Professor, Consultant Jens Børglum
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Scheduled for elective unilateral mastectomy and primary reconstructive surgery (UMPR) with subpectoral implant due to breast cancer
- •Age above/equal to 18 years at the date of inclusion
- •Have received thorough information, orally and in written, and signed the Informed Consent” form on participation in the study.
- •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 30
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 6
Exclusion Criteria
- •Scheduled for elective UMPR surgery due to breast cancer combined with simultaneous contralateral major breast surgery (mastectomy, mastopexy and subpectoral breast reconstruction). Minor contralateral surgery (e.g. lipofilling) are accepted.
- •Scheduled free flap reconstructive surgery
- •Inability to cooperate
- •Inability to speak, read and understand Danish
- •Allergy to local anaesthetics or opioids
- •Daily intake of opioids, according to the investigators decision
- •Illegal drug and/or substance abuse, according to the investigators decision
- •Local infection at the site of injection or systemic infection
- •Difficult sonoanatomical visualisation of the target area necessary for the block execution
- •Substantial co\-morbidity, ASA\>3
Outcomes
Primary Outcomes
Not specified
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