A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | February 2016 |
| Contact: | Lutfullah Baskoy, MD |
| Email: | lutfullah.baskoy@yale.edu |
| Phone: | 203-787-6851 |
A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
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.
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.
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.
We found this trial at
1
site
20 York St, N20 York St,
New Haven, Connecticut 06520
New Haven, Connecticut 06520
(203) 688-4242
Phone: 203-785-7313
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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