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Paravertebral Blocks for Breast Cancer 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: NCT01904266
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

This research project intends to look at the effect that a certain type of freezing injection, called a paravertebral block, has on the pain after an operation for breast cancer, the amount of pain relief that is needed and the side effects from this pain relief. The hypothesis is that the paravertebral block, in combination with a general anesthetic will reduce both pain scores and the amount of strong pain killers (opioids) that is needed. This will reduce the side effects of the pain killers such as nausea and vomiting.

This will be assessed by comparing it a general anesthetic with pain killers given through the intravenous (IV) as is routine practice. Patients requiring breast cancer surgery, who agree to be involved in the trial, will be randomly allocated into two groups: both groups will receive a block, then a standardised and optimised general anesthetic. In one group however the block is simply a small injection under the skin (a sham block), whereas the other group will receive a proper paravertebral block prior to this. Both groups will receive opioids as necessary, depending on both their bodies reaction during the surgery and their pain scores when they wake up.

The paravertebral block is a very safe procedure with a very low side effect profile, and many studies have shown a benefit in breast cancer surgery. The investigators would like to assess this in our own practice. The block is normally inserted under some light sedation, with freezing into the skin initially. It is normally very well tolerated. The sham block will also be performed under light sedation and freezing into the skin. The patients will not be able to tell whether they are having the sham block or the paravertebral block, because both are very well tolerated. There are no potential complications from the sham block.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Nerve Block Procedure: GA + paravertebral block Procedure: GA + sham block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Combined General Anesthesia Plus Paravertebral Block Versus General Anesthesia Plus Opioid Analgesia for Breast Cancer Surgery: A Prospective Randomized Trial
Actual Study Start Date : May 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: GA + sham block
Patients will receive general anesthetic plus a sham paravertebral block
Procedure: GA + sham block
Injection of 1 cc saline subcutaneously

Experimental: GA + paravertebral block
Patients will receive general anesthetic plus a paravertebral block
Procedure: GA + paravertebral block
20 cc ropivacaine 0.2% will be administered in an ultrasound-guided paravertebral block




Primary Outcome Measures :
  1. Post-operative analgesia consumption [ Time Frame: 24 hours post-surgery ]
    Amount of morphine consumed in the 24 hours following surgery will be recorded


Secondary Outcome Measures :
  1. Post-operative pain [ Time Frame: 24 hours post-surgery ]
    Pain in the 24 hours following surgery will be assessed using a VAS scale

  2. Nausea/vomiting [ Time Frame: 24 hours post-surgery ]
    Incidence of nausea and vomiting in the 24 hours following surgery will be recorded on a 4-point scale

  3. Pain upon movement [ Time Frame: Within half an hour of return to recovery room ]
    Maximum pain score will be recorded in recovery at rest and on shoulder abduction

  4. Intraoperative opioid requirement [ Time Frame: During surgery ]
    Opioid consumption during surgery will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Listed for Total Mastectomy +/- Axillary Node Dissection, or Partial Mastectomy

Exclusion Criteria:

  • Patient refusal or inability to give informed consent
  • Any contraindication for paravertebral blockade: coagulopathy, severe respiratory disease, local infection, untreated severe hypovolemia
  • Allergy to propofol, severe egg allergy, or allergy to local anaesthetic agents
  • Mastectomy plus flap reconstruction
  • Bilateral procedures

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): NCT01904266


Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2G3
Sponsors and Collaborators
University of Alberta
Publications:
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01904266    
Other Study ID Numbers: Pro00028824
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms