Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction

NCT02525718 | Completed Phase 2 Results

• 1 other identifier: STU00200903
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects are being asked to participate in this study because they will be undergoing unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction involving insertion of a tissue expander.

Conditions

Breast Cancer

Keywords

Breast Reconstruction; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery Score

  The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the "Global 40 Item Quality of Recovery" survey. This is a 40 question survey administered to patients to allow them to rate their quality of recovery along a number of different dimensions, including emotional state, physical comfort, psychological support, physical independence, and pain. The score ranges from 40 to 200, with 40 representing a very poor overall quality of recovery and 200 representing the best possible recovery. The following reference explains the Global 40 Item Quality of Recovery survey in detail: Myles, P.S., et al., Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth, 2000. 84(1): p. 11-5. PMID: 10740540

  24 hours post-operatively

Secondary Outcomes (3)

• Pain Score Using 10-point Visual Analog Scale (VAS)

  24 hrs

• Opioid Consumption

  24 hrs

• Length of Hospital Stay

  4 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.

Drug: Saline

0.25 % bupivacaine w/ epinephrine & 4mg dexamethasone

ACTIVE COMPARATOR

Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.

Drug: 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone

Interventions

Saline DRUG

If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)

Also known as: Sodium Chloride 0.9%

Placebo

0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone DRUG

If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.

Also known as: Bupivacaine

0.25 % bupivacaine w/ epinephrine & 4mg dexamethasone

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergo mastectomy surgery with immediate reconstruction involving insertion of a tissue expander performed by the principal investigator beginning from the time of study approval until study enrollment is complete.

You may not qualify if:

• Patients under the age of 18, or over the age of 79
• Allergy to local anesthetics or corticosteroids
• Patients with history of chronic pain or with chronic use of opioid analgesics
• Patients with history of lung disease or prior anterior thoracotomy or median sternotomy

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sodium Chloride; Bupivacaine; Epinephrine; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Mohammed Alghoul
• Organization: Northwestern Memorial Hospital

malghoul@nm.org

Study Officials

• Mohammed Alghoul, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: August 17, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-07

Locations

US (1)