drugset / Trial / NCT02544282

Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery

NCT02544282

Phase 4 Completed 140 enrolled GZA Ziekenhuizen Campus Sint-Augustinus
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to general anesthesia with opioids combined with a Pecs II block or to general anesthesia with opioids combined with a placebo Pecs II block. Participants will be followed postoperatively during their entire hospital stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II block and opioids as postoperative pain treatment.

Timeline

Start
2014-04
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levobupivacaine Other / unclassified
Comparator Acetaminophen Small molecule
Comparator Atracurium Small molecule
Comparator Piritramide Small molecule
Comparator Propofol Small molecule
Comparator Sevoflurane Other / unclassified
Comparator Sufentanil Other / unclassified
Comparator Tramadol Other / unclassified

Indications

No indication recorded.