Post-discharge Pain After Breast-surgery Treated by Paravertebral Block

August 1, 2018 updated by: Samuele Ceruti

Persistent Post-discharge Pain After Breast Surgery With Paravertebral Block: Incidence, Characteristics and Consequences

Breast surgery is known being associated to a high risk of persistent post-operative pain, which has been related, among other factors, to a poorly treated acute pain. Paravertebral block has been successfully employed for anesthesia and analgesia after breast surgery, however its impact on persistent post-operative pain has rarely been investigated. Aim of this study is to assess prevalence, characteristics and consequences of post-discharge pain and its correlation to the incidence of persistent post-operative pain development in a continuous cohort of patients undergoing breast surgery with a paravertebral block.

Investigators designed a prospective, observational study on a continuous cohort of adult patients undergoing breast surgery with a standardized thoracic paravertebral block performed before general anesthesia induction. Patients were subsequently interviewed 6 months after hospital discharge in order to assess the incidence, features and duration of post-discharge pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the most frequent cancer in women, with an incidence of more than one million new cases per year. In the majority of cases surgery is part of the treatment and prognosis has progressively improved during last years. Attention is thus being increasingly focusing on these patients' quality of life and chronic postsurgical pain, defined as pain in the area of surgery lasting beyond 3 month from the operation, has emerged as a frequent long-term complication, with prevalence up to 60%. This often-disabling condition has been shown to significantly affect cancer survivors' quality of life and to have a heavy economic impact on the healthcare system.

Many potential risk factors have been proposed for the development of chronic post-breast surgery pain. A Cochrane systematic review has addressed the role of regional anesthesia in preventing the development of chronic postoperative pain, suggesting that "paravertebral block may reduce the pain after breast cancer surgery in about one out every five women treated", these results being however weakened by the often poor quality and inadequate power of the studies available. Many predictors of chronic postoperative pain have been identified, one of them being a poorly treated acute pain; in this perspective, regional anesthesia could possibly play a role in preventing nervous system remodeling with resultant hyperalgesia, allodynia and sustained wound pain.

Even if chronic postoperative pain has been progressively recognized as an issue after breast cancer surgery, its link to poorly treated acute postoperative pain and post-discharge pain (PDP) has been poorly investigated. Single shot paravertebral block is an effective technique to provide both anesthesia and good analgesia after breast surgery, but its benefits duration is still debated.

Study Type

Observational

Enrollment (Actual)

244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Andrea Saporito MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

A consecutive cohort of adult patients undergoing breast surgery with a combined anesthesia technique, employing a thoracic single-shot paravertebral block performed before surgery. Operations performed were in all cases unilateral tumor resections, lumpectomies and mastectomies without axillary lymphadenectomy.

Description

Inclusion Criteria:

  • female sex
  • 18 years or greater
  • elective breast surgery (tumor resection, mastectomy, lumpectomy)
  • local regional anesthesia

Exclusion Criteria:

  • patients refusal,
  • general contraindications to regional anesthesia,
  • the inability to perform a complete block
  • diagnosed COPD or other respiratory diseases,
  • ASA score risk greater than 3.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast-surgery patients
A consecutive cohort of adult patients undergoing breast surgery with a combined anesthesia technique, employing a thoracic single-shot paravertebral block performed before surgery. Operations performed were in all cases unilateral tumor resections, lumpectomies and mastectomies without axillary lymphadenectomy.
Other: Phone questionnaire
Patients were contacted by phone 6 months after surgery and, after oral consent, a standardized questionnaire was administered in order to inquiry about the length and nature of post-operative pain, the incidence of post-discharge pain, its characteristics, its impact on daily life, its treatment and its rate of chronicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-discharge pain
Time Frame: 6 months post-surgery
Primary endpoint of this study is to assess the incidence of post-discharge pain in a cohort of patients undergoing breast surgery with a single shot thoracic paravertebral block.
6 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain characteristics
Time Frame: 6 months post-surgery
Secondary endpoints is to characterize this post-discharge pain in terms of pain characteristics, evaluated by Numerical Rating Scale (NRS, from 0 intended as no pain, to 10 as maximal pain), on patient daily life after discharge home.
6 months post-surgery
Pain impact
Time Frame: 6 months post-surgery
Secondary endpoints is to characterize this post-discharge pain in terms of pain impact on patient daily life after discharge home, intended as capable to impact especially on a) work, b) leisure or c) sleep.
6 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samuele Ceruti

Collaborators

Ente Ospedaliero Cantonale, Bellinzona

Investigators

  • Study Chair: Luciano Anselmi, MD, Ente Ospedaliero Cantonale, Bellinzona
  • Principal Investigator: Andrea Saporito, MD, Ente Ospedaliero Cantonale, Bellinzona
  • Study Director: José Aguirre, MD, Balgrist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CERU-1802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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