Post-operative Pain
Conditions
Keywords
pain, breast cancer, breast implant, breast reconstruction
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.
Interventions
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Questionnaire | Post Operation Week 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. 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blinded Group A | 2 |
| Blinded Group B | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | study terminated | 2 | 0 |
Baseline characteristics
| Characteristic | Blinded Group A | Blinded Group B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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
Population: The study was terminated after 2 subjects enrolled and outcomes were never fully collected not summarized.
Secondary
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
Population: The study was terminated after 2 subjects enrolled and outcomes were never summarized.
Secondary
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 One Month
Population: The study was terminated after 2 subjects enrolled and outcomes were never summarized.