Back to resultsA Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Primary Purpose
Post-operative Pain
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Botulinum Toxins
Analgesics
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring pain, breast cancer, breast implant, breast reconstruction
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.
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
standard analgesics
standard analgesics and bupivacaine
standard analgesics and botulinum toxins
standard analgesics, bupivacaine and botulinum toxins
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02044302
Brief Title
A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Official Title
A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
pain, breast cancer, breast implant, breast reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard analgesics
Arm Type
Active Comparator
Arm Description
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.
Arm Title
standard analgesics and bupivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
standard analgesics and botulinum toxins
Arm Type
Experimental
Arm Description
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.
Arm Title
standard analgesics, bupivacaine and botulinum toxins
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Exparel, Marcaine, Sensorcaine
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxins
Other Intervention Name(s)
Botox
Intervention Type
Drug
Intervention Name(s)
Analgesics
Other Intervention Name(s)
narcotic, morphine, sedative, valium
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Kwei, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
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A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
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