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

January 21, 2014
April 30, 2014
April 2014
January 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02044302 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Post-operative Pain
  • Drug: Bupivacaine
    Other Names:
    • Exparel
    • Marcaine
    • Sensorcaine
  • Drug: Botulinum Toxins
    Other Name: Botox
  • Drug: Analgesics
    Other Names:
    • narcotic
    • morphine
    • sedative
    • valium
  • 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.
    Intervention: Drug: Analgesics
  • 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.
    Interventions:
    • Drug: Bupivacaine
    • Drug: Analgesics
  • 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.
    Interventions:
    • Drug: Botulinum Toxins
    • Drug: Analgesics
  • 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.
    Interventions:
    • Drug: Bupivacaine
    • Drug: Botulinum Toxins
    • Drug: Analgesics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
February 2016
January 2016   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Lutfullah Baskoy, MD 203-787-6851 lutfullah.baskoy@yale.edu
United States
 
NCT02044302
Kwei11.13.13
No
Yale University
Yale University
Yale New Haven Health System Center for Healthcare Solutions
Principal Investigator: Stephanie Kwei, MD Yale University
Yale University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP