Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

NCT00542542 | Completed Phase 3 Results DMC

• 2 other identifiers: 2006-0961NCI-2012-01557
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only general anesthesia. Secondary Objectives:

1. 1.To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative pain in the first 24 hours after surgery compared with patients having only general anesthesia.
2. 2.To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative nausea and vomiting in the first 24 hours as compared with patients having only general anesthesia.
3. 3.To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in a decreased length of hospital stay compared with patients having only general anesthesia.

Conditions

Breast Cancer

Keywords

Breast Cancer; Reconstructive Surgery; Paravertebral Block; Anesthesia; Propofol; Fentanyl; Ropivacaine; Midazolam

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With No Pain Immediately After Surgery

  Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 - 24 hours post-operatively).

  Starting immediately after surgery, every 2 hours till the 6th hour following surgery

Study Arms (2)

Paravertebral Block + General Anesthesia

ACTIVE COMPARATOR

Group 1: Paravertebral Block + General Anesthesia (Ropivacaine)

Procedure: Paravertebral Block; Drug: Ropivacaine

General Anesthesia Alone

ACTIVE COMPARATOR

Group 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl)

Drug: Propofol; Drug: Fentanyl; Drug: Midazolam

Interventions

Paravertebral Block PROCEDURE

Paravertebral block given as a bolus injection into the paravertebral space.

Paravertebral Block + General Anesthesia

Propofol DRUG

2-2.5 mg/kg IV over 1-4 hours during surgery.

General Anesthesia Alone

Fentanyl DRUG

50-250 mcg IV over 1-4 hours during surgery.

General Anesthesia Alone

Ropivacaine DRUG

Ropivacaine given by injection into the paravertebral space along the spinal canal.

Paravertebral Block + General Anesthesia

Midazolam DRUG

0.08 mg/kg IV over 1-4 hours during the surgery.

General Anesthesia Alone

Eligibility Criteria

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

You may qualify if:

• Patients that consent to participate
• Patients undergoing reconstructive breast surgery either in combination with oncologic surgery or alone
• Patients that are female
• Patients that are over the age of 18

You may not qualify if:

• Patients on chronic anti-emetics (ie. chronic= more than once every two days for greater than 2 weeks)
• Patients on chronic pain medication (ie. chronic= more than once every two days for greater than 2 weeks) excluding Aspirin, acetaminophen and NSAID's
• Patients with BMI\<20 or \>40
• Patients that are pregnant
• Patients with chronic pain syndromes.
• Patients with hypersensitivity to ropivacaine/amide-type anesthetics should be excluded from this trial as this would be a contraindication

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Propofol; Fentanyl; Ropivacaine; Midazolam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study completed with measurement reporting issues (inconsistencies) leading to uninterpretable data.

Results Point of Contact

• Title: Dr. Farzin Goravanchi, Professor, Anesthesiology & Perioperative Medicine
• Organization: University of Texas MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-563-5613

Study Officials

• Farzin Goravanchi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 13, 2015
• Results First Posted: April 13, 2015

Record last verified: 2015-03

Locations

US (1)