Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Active 18 and over Other 2006-0961 NCT00542542

Trial Description

Summary

Primary Objective:

1. 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. 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. 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 compared with patients having only general anesthesia.

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.

Further Study Information

PARAVERTEBRAL BLOCKS AND GENERAL ANESTHESIA:

The use of a paravertebral block involves injecting local anesthesia (a numbing medicine) into the patient's back to numb specific areas (the breast[s] for this study) for surgery.

General anesthesia is medicine that is used to put patients to sleep so that there is no feeling of pain.

SCREENING TESTS:

Before you can start on this study, you will have "screening tests." These tests will help the study doctor decide if you are eligible to take part in this study.

Within 4 weeks before starting on this study, you will have the following tests done:

• You will have a complete physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight.

• Your medical history will be recorded.

• You will be asked about medications you may be currently taking, including those prescribed by your doctor and over-the-counter drugs.

• Women who are able to have children must have a negative blood pregnancy test.

STUDY GROUPS:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. You will have an equal (50/50) chance of being assigned to either group.

Participants in one group will receive a paravertebral block (the local anesthetic ropivicaine) plus general anesthesia.

Participants in the other group will receive general anesthesia (propofol, desflurane, and fentanyl) without a paravertebral block.

DRUG ADMINISTRATION:

If you are assigned to receive the paravertebral block plus general anesthesia, you will have a paravertebral block placed just before surgery begins. Ropivacaine will be given by injection into the paravertebral space along the spinal canal.

If you are assigned to receive general anesthesia without a paravertebral block, you will be given propofol, desflurane, and fentanyl by vein over 1-4 hours during surgery.

Participants in both groups will receive promethazine, famotidine, and dexamethasone at the start of surgery to help decrease or eliminate nausea and vomiting that may occur after surgery.

FOLLOW-UP:

After your surgery is complete, before you leave the hospital, you will have the following evaluations:

• You will be asked how you are feeling so that the study doctor can determine how much medication you may need for pain and nausea as well as how long your hospital stay may need to be. You may be given fentanyl and dilaudid for pain and ondansetron and promethazine for nausea.

• You will also be asked about your satisfaction with the anesthesia. You will be asked these questions immediately after surgery and at 1, 3, and 6 hours after surgery. Once you are discharged from the hospital, study staff will contact you by phone or talk with you when you return for a visit (at 1 week and 1 month after surgery) to ask these questions. It will take about 3-5 minutes to ask these questions each time.

LENGTH OF STUDY:

Your participation in this study will be over after the 1-month follow-up evaluation is completed.

This is an investigational study. Paravertebral blocks and general anesthesia are FDA approved and commercially available. You and/or your insurance provider will be financially responsible for the cost of all the drugs used in this study. Up to 89 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria

Inclusion Criteria:

• 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

• Patients on anti-coagulants or other blood thinning medications will be eligible for inclusion if they stop taking these medications for at least the time specified below prior to date of surgery: Low molecular weight heparin must stop at least 36 hours prior to surgery. Coumadin must stop at least 5 days prior to surgery. Aspirin, Plavix and NSAIDs must stop at least 7 days prior to surgery.

Exclusion Criteria:

• 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 and musculoskeletal disorders

• Patients with hypersensitivity to ropivacaine/amide-type anesthetics should be excluded from this trial as this would be a contraindication

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Farzin Goravanchi, MD

Principal Investigator

Farzin Goravanchi, MD

Ph: 713-563-5613

U.S.A.
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Farzin Goravanchi, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00542542
Information obtained from ClinicalTrials.gov on July 16, 2008