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

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Analgesics; Botulinum Toxins; Bupivacaine; Diazepam; Hypnotics and Sedatives; Morphine; Narcotics

Criteria

Inclusion Criteria:

• Women undergoing immediate unilateral or bilateral tissue expander breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy requiring postoperative expansions

• Women undergoing immediate bilateral tissue expanders breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy requiring postoperative tissue expansions.

Exclusion Criteria:

• Subjects who are unable to read or speak English;

• Breast reconstruction using the latissimus dorsi flap combined with a tissue expander;

• Documented diagnosis of chronic pain, chronic migraine, upper limb spasticity, cervical dystonia, axillary hyperhidrosis, strabismus or blepharospasm;

• Hypersensitivity to any botulinum toxin (BT) preparation or to any of the components in the formulation;

• Infection at the proposed site of injection;

• Pre-existing neuromuscular disorders (including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis);

• Aminoglycosides intake at the time of surgery (these antibiotics can potentiate the effect of BT);

• Women who are pregnant or breast feeding.