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

Phase 2TerminatedNCT02044302

Yale University2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Post-operative Pain

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain Score Questionnaire

The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain you had. The other numbers mean that pain is in perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.

Time frame: Post Operation Day 1

Secondary Outcomes

Pain Score Questionnaire

The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain. The other numbers mean that pain is perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.

Time frame: Post Operation Week 1

Pain Score Questionnaire

Time frame: Post Operation One Month

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes