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

NCT ID: NCT02044302

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-01-31

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.

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

standard analgesics

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.

Group Type: ACTIVE_COMPARATOR

Analgesics

Intervention Type: DRUG

standard analgesics and bupivacaine

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.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Analgesics

Intervention Type: DRUG

standard analgesics and botulinum toxins

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.

Group Type: EXPERIMENTAL

Botulinum Toxins

Intervention Type: DRUG

Analgesics

Intervention Type: DRUG

standard analgesics, bupivacaine and botulinum toxins

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.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Botulinum Toxins

Intervention Type: DRUG

Analgesics

Intervention Type: DRUG

Interventions

Bupivacaine

Intervention Type: DRUG

Botulinum Toxins

Intervention Type: DRUG

Analgesics

Intervention Type: DRUG

Other Intervention Names

Exparel; Marcaine; Sensorcaine; Botox; narcotic; morphine; sedative; valium

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Kwei, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1304011938

Identifier Type: -

Identifier Source: org_study_id