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

Post-operative Pain Clinical Trial

Official title:
A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02044302
Study type Interventional
Source Yale University
Contact
Status Terminated
Phase Phase 2
Start date April 2014
Completion date January 2016
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