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Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery

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.

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
ropivacaine) 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


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

- 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 within the first hour, between 1 and 3 hours, and between 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 18 -22 hours and 1 week 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 week follow-up telephone call.

This is an investigational study. Paravertebral blocks and general anesthesia are FDA
approved and commercially available. Up to 89 patients will take part in this study. All
will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patients that consent to participate

2. Patients undergoing reconstructive breast surgery either in combination with
oncologic surgery or alone

3. Patients that are female

4. Patients that are over the age of 18

5. 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:

1. Patients on chronic anti-emetics (ie. chronic= more than once every two days for
greater than 2 weeks)

2. Patients on chronic pain medication (ie. chronic= more than once every two days for
greater than 2 weeks) excluding Aspirin, acetaminophen and NSAID's

3. Patients with BMI<20 or >40

4. Patients that are pregnant

5. Patients with chronic pain syndromes.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Proportion of Patients with No Pain Immediately After Surgery

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Farzin Goravanchi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Reconstructive Surgery
  • Paravertebral Block
  • Anesthesia
  • Propofol
  • Fentanyl
  • Ropivacaine
  • Midazolam
  • Breast Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030