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

NCT02044302 | Terminated Phase 2 Results

• 1 other identifier: 1304011938
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Keywords

pain; breast cancer; breast implant; breast reconstruction

Outcome Measures

Primary Outcomes (1)

• 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.

  Post Operation Day 1

Secondary Outcomes (2)

• Pain Score Questionnaire

  Post Operation Week 1

• Pain Score Questionnaire

  Post Operation One Month

Study Arms (4)

standard analgesics

ACTIVE COMPARATOR

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

standard analgesics and bupivacaine

EXPERIMENTAL

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; Drug: Analgesics

standard analgesics and botulinum toxins

EXPERIMENTAL

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; Drug: Analgesics

standard analgesics, bupivacaine and botulinum toxins

EXPERIMENTAL

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; Drug: Botulinum Toxins; Drug: Analgesics

Interventions

Bupivacaine DRUG

Also known as: Exparel, Marcaine, Sensorcaine

standard analgesics and bupivacaine; standard analgesics, bupivacaine and botulinum toxins

Botulinum Toxins DRUG

Also known as: Botox

standard analgesics and botulinum toxins; standard analgesics, bupivacaine and botulinum toxins

Analgesics DRUG

Also known as: narcotic, morphine, sedative, valium

standard analgesics; standard analgesics and botulinum toxins; standard analgesics and bupivacaine; standard analgesics, bupivacaine and botulinum toxins

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Breast Neoplasms

Interventions

Bupivacaine; Botulinum Toxins; Botulinum Toxins, Type A; Analgesics; Narcotics; Morphine; Hypnotics and Sedatives; Diazepam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Central Nervous System Depressants; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Results Point of Contact

• Title: Katisha Brown CPC
• Organization: Yale Center for Clinical Investigations

katisha.brown@yale.edu

(203) 737-7495

Study Officials

• Stephanie Kwei, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-02

Locations

US (1)