Spots Global Cancer Trial Database for A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
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Trial Identification
Brief Title: A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Official Title: A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Study ID: NCT02044302
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Yale New Haven Hospital, New Haven, Connecticut, United States
Contact Details
Name: Stephanie Kwei, MD
Affiliation: Yale University
Role: PRINCIPAL_INVESTIGATOR
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