drugset / Trial / NCT02044302

A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction

NCT02044302

Phase 2 Terminated 2 enrolled Yale University
RandomizedParallel-groupTriple-blindTreatment

Summary

The investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the acute and chronic setting, compared to traditional pain management techniques which rely almost exclusively on opioid analgesics and sedatives like diazepam (valium). This expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will produce muscle relaxation, the combination of which will target different sites of pain generation, thus producing better analgesia. We also hypothesize that additional benefits may accrue from this regimen including decreased nausea and vomiting, sedation and constipation as a result of diminished opioid use1.

Timeline

Start
2014-04
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu Intramuscular
Subject Bupivacaine Other / unclassified 0.5 % Intramuscular
Subject Bupivacaine Other / unclassified 10 ml Intramuscular
Background Diazepam Small molecule
Background Morphine Other / unclassified

Indications

No indication recorded.