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

Yale University

Status and phase: Terminated; Phase 2

Conditions: Post-operative Pain

Treatments: Drug: Botulinum Toxins; Drug: Bupivacaine; Drug: Analgesics

Study type: Interventional

Funder types: Other

Identifiers

NCT02044302

1304011938

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 4 patient groups

standard analgesics

Active Comparator group

Description:

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.

Treatment:

Drug: Analgesics

standard analgesics and bupivacaine

Experimental group

Description:

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.

Treatment:

Drug: Analgesics

Drug: Bupivacaine

standard analgesics and botulinum toxins

Experimental group

Description:

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.

Treatment:

Drug: Analgesics

Drug: Botulinum Toxins

standard analgesics, bupivacaine and botulinum toxins

Experimental group

Description:

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.

Treatment:

Drug: Analgesics

Drug: Bupivacaine

Drug: Botulinum Toxins