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

Phase 2

Terminated

Conditions: Post-operative Pain

Interventions: Drug: Analgesics
Drug: Bupivacaine
Drug: Botulinum Toxins

Registration Number: NCT02044302

Lead Sponsor: Yale University

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: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 2

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard analgesics	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.
standard analgesics and bupivacaine	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.
standard analgesics, bupivacaine and botulinum toxins	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 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.
standard analgesics, bupivacaine and botulinum toxins	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.
standard analgesics and bupivacaine	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). 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.
standard analgesics and botulinum toxins	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.
standard analgesics and botulinum toxins	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). 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.
standard analgesics, bupivacaine and botulinum toxins	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). 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.

Primary Outcome Measures

Name	Time	Method
Pain Score Questionnaire	Post Operation Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Pain Score Questionnaire	Post Operation One Month	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.