A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Drug: Analgesics
Other Names:
|
| Experimental: 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. |
Drug: Bupivacaine
Other Names:
Drug: Analgesics
Other Names:
|
| Experimental: 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. |
Drug: Botulinum Toxins
Other Names:
Drug: Analgesics
Other Names:
|
| Experimental: 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. |
Drug: Bupivacaine
Other Names:
Drug: Botulinum Toxins
Other Names:
Drug: Analgesics
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale New Haven Hospital | New Haven | Connecticut | United States | 06510 |
Sponsors and Collaborators
- Yale University
Investigators
- Principal Investigator: Stephanie Kwei, MD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1304011938
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Blinded Group A | Blinded Group B |
|---|---|---|
| Arm/Group Description | ||
| Period Title: Overall Study | ||
| STARTED | 2 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Blinded Group A | Blinded Group B | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Overall Participants | 2 | 0 | 2 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
NaN
|
0
0%
|
| Between 18 and 65 years |
2
100%
|
0
NaN
|
2
100%
|
| >=65 years |
0
0%
|
0
NaN
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
100%
|
0
NaN
|
2
100%
|
| Male |
0
0%
|
0
NaN
|
0
0%
|
Outcome Measures
| Title | Pain Score Questionnaire |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study was terminated after 2 subjects enrolled and outcomes were never fully collected not summarized. |
| Arm/Group Title | Terminated Cohort |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
| Title | Pain Score Questionnaire |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study was terminated after 2 subjects enrolled and outcomes were never summarized. |
| Arm/Group Title | Terminated Cohort |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
| Title | Pain Score Questionnaire |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study was terminated after 2 subjects enrolled and outcomes were never summarized. |
| Arm/Group Title | Terminated Cohort |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Terminated Cohort | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Terminated Cohort | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | |
Serious Adverse Events |
||
| Terminated Cohort | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Terminated Cohort | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Katisha Brown CPC |
|---|---|
| Organization | Yale Center for Clinical Investigations |
| Phone | (203) 737-7495 |
| katisha.brown@yale.edu |
- 1304011938