Paravertebral Blocks for Breast Cancer Surgery

NCT01904266 | Completed

• 1 other identifier: Pro00028824
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Nerve Block

Outcome Measures

Primary Outcomes (1)

• Post-operative analgesia consumption

  Amount of morphine consumed in the 24 hours following surgery will be recorded

  24 hours post-surgery

Secondary Outcomes (4)

• Post-operative pain

  24 hours post-surgery

• Nausea/vomiting

  24 hours post-surgery

• Pain upon movement

  Within half an hour of return to recovery room

• Intraoperative opioid requirement

  During surgery

Study Arms (2)

GA + sham block

SHAM COMPARATOR

Patients will receive general anesthetic plus a sham paravertebral block

Procedure: GA + sham block

GA + paravertebral block

EXPERIMENTAL

Patients will receive general anesthetic plus a paravertebral block

Procedure: GA + paravertebral block

Interventions

GA + paravertebral block PROCEDURE

20 cc ropivacaine 0.2% will be administered in an ultrasound-guided paravertebral block

GA + paravertebral block

GA + sham block PROCEDURE

Injection of 1 cc saline subcutaneously

GA + sham block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (6)

• Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534.

  PMID: 18682712 BACKGROUND

• Poleshuck EL, Katz J, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for chronic pain following breast cancer surgery: a prospective study. J Pain. 2006 Sep;7(9):626-34. doi: 10.1016/j.jpain.2006.02.007.

  PMID: 16942948 BACKGROUND

• Gartner R, Kroman N, Callesen T, Kehlet H. Multimodal prevention of pain, nausea and vomiting after breast cancer surgery. Minerva Anestesiol. 2010 Oct;76(10):805-13.

  PMID: 20935616 BACKGROUND

• Karmakar MK. Thoracic paravertebral block. Anesthesiology. 2001 Sep;95(3):771-80. doi: 10.1097/00000542-200109000-00033. No abstract available.

  PMID: 11575553 BACKGROUND

• Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.

  PMID: 20947592 BACKGROUND

• Shkol'nik LD, Vasil'ev VIu, Soboleva LV. [Multi-injection thoracic paravertebral anesthesia during breast cancer operations]. Anesteziol Reanimatol. 2006 Jul-Aug;(4):80-5. Russian.

  PMID: 17061598 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: July 22, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CA (1)