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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Yale University
Sponsor:
Collaborator:
Yale New Haven Health System Center for Healthcare Solutions
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02044302
First received: January 21, 2014
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Post-operative Pain
Drug: Bupivacaine
Drug: Botulinum Toxins
Drug: Analgesics
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Pain Score Questionnaire [ Time Frame: Post Operation Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post Operation Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post Operation One Month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: April 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • narcotic
  • morphine
  • sedative
  • valium
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:
  • Exparel
  • Marcaine
  • Sensorcaine
Drug: Analgesics
Other Names:
  • narcotic
  • morphine
  • sedative
  • valium
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 Name: Botox
Drug: Analgesics
Other Names:
  • narcotic
  • morphine
  • sedative
  • valium
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:
  • Exparel
  • Marcaine
  • Sensorcaine
Drug: Botulinum Toxins
Other Name: Botox
Drug: Analgesics
Other Names:
  • narcotic
  • morphine
  • sedative
  • valium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044302

Contacts
Contact: Lutfullah Baskoy, MD 203-787-6851 lutfullah.baskoy@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Stephanie Kwei, MD    203-785-7313    stephanie.kwei@yale.edu   
Sponsors and Collaborators
Yale University
Yale New Haven Health System Center for Healthcare Solutions
Investigators
Principal Investigator: Stephanie Kwei, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02044302     History of Changes
Other Study ID Numbers: Kwei11.13.13
Study First Received: January 21, 2014
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
pain
breast cancer
breast implant
breast reconstruction

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Morphine
Botulinum Toxins
Bupivacaine
Diazepam
Hypnotics and Sedatives
Narcotics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Dyskinesia Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Adjuvants, Anesthesia
Anticonvulsants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on August 25, 2014