Conditions: Post-operative Pain
Keywords: pain breast cancer breast implant breast reconstruction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

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:

Arms:
arm 1: Current standard post-operative care for expander-implant breast reconstruction surgery consists of conventional pain medications including narcotics (like morphine, etc.) and sedatives (like valium). Placebo application during surgery will be made to establish perfection in the study design in terms of randomization and blinding. Injections will be done intramuscularly to the main chest muscle (pectoralis major) by the surgeon. arm 2: Current standard post-operative care for expander-implant breast reconstruction surgery consists of conventional pain medications including narcotics (like morphine, etc.) and sedatives (like valium). Patients will receive through an injection into the chest 10 ml (about 2 teaspoons) of 0.5% bupivacaine during surgery. Injections will be done intramuscularly to the main chest muscle (pectoralis major) by the surgeon. arm 3: Current standard post-operative care for expander-implant breast reconstruction surgery consists of conventional pain medications including narcotics (like morphine, etc.) and sedatives (like valium). Patients will receive through an injection into your chest 50 U of Botox diluted in 4ml (about 1 teaspoon) of normal saline per breast during your operation. Injections will be done intramuscularly to the main chest muscle (pectoralis major) by the surgeon. arm 4: Current standard post-operative care for expander-implant breast reconstruction surgery consists of conventional pain medications including narcotics (like morphine, etc.) and sedatives (like valium). Patients will receive through an injection into your chest 10 ml (about 2 teaspoons) of 0.5% bupivacaine and 50 U of Botox diluted in 4ml (about 1 teaspoon) of normal saline per breast during the operation. Injections will be done intramuscularly to the main chest muscle (pectoralis major) by the surgeon.

Interventions: intervention 1: Bupivacaine intervention 2: Botulinum Toxins intervention 3: Analgesics
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: