A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Status:
Terminated
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Yale University
Treatments:
Analgesics Botulinum Toxins Bupivacaine Diazepam Hypnotics and Sedatives Morphine Narcotics