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Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00542542
Recruitment Status : Completed
First Posted : October 11, 2007
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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. 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 in the first 24 hours as 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Paravertebral Block Drug: Propofol Drug: Fentanyl Drug: Ropivacaine Drug: Midazolam Phase 3

Detailed Description:

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 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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery
Study Start Date : September 2007
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Paravertebral Block + General Anesthesia
Group 1: Paravertebral Block + General Anesthesia (Ropivacaine)
 Procedure: Paravertebral Block
Paravertebral block given as a bolus injection into the paravertebral space.

Drug: Ropivacaine
Ropivacaine given by injection into the paravertebral space along the spinal canal.
Active Comparator: General Anesthesia Alone
Group 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
 Drug: Propofol
2-2.5 mg/kg IV over 1-4 hours during surgery.

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants With No Pain Immediately After Surgery [ Time Frame: Starting immediately after surgery, every 2 hours till the 6th hour following 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542542


Locations
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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Farzin Goravanchi, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00542542    
Other Study ID Numbers: 2006-0961
NCI-2012-01557 ( Registry Identifier: NCI CTRP )
First Posted: October 11, 2007    Key Record Dates
Results First Posted: April 13, 2015
Last Update Posted: April 13, 2015
Last Verified: March 2015
Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Reconstructive Surgery
Paravertebral Block
Anesthesia
 Propofol
Fentanyl
Ropivacaine
Midazolam
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fentanyl
Midazolam
Propofol
Ropivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
 Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action