The Effect of the Serratus Block on Pain Control After Breast Surgery

January 7, 2020 updated by: Women's College Hospital

The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study

Surgery for breast cancer is associated with significant pain. The serratus nerve block targets the interfascial plane either below or above the serratus muscle, blocking thereby the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized controlled double-blinded study is to see whether the addition of a serratus nerve block to a general anesthesia results in a better postoperative pain control in patients undergoing surgery for breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of severe acute postoperative pain after breast surgery is high. Regional anesthesia has the potential to provide superior pain relief with fewer side effects compared to standard systemic opioid therapy. The search for a regional anesthesia technique for breast surgery has been ongoing as this technique needs to be time efficient, relatively risk-free and also practicable in an out-patient setting. The serratus block is a promising technique that may combine these advantages.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Women's College Hospital

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
  • undergoing unilateral primary or secondary breast surgery for cancer, specifically: lumpectomies with sentinel node biopsy or partial mastectomies or simple mastectomies, with or without sentinel node biopsy
  • day surgery procedures

Exclusion Criteria:

  • inability to understand or to provide consent
  • inability or unwillingness to comply with required follow-up assessments
  • psychiatric disorder affecting patient assessment
  • contraindication to regional anesthesia, e.g., coagulopathy
  • allergy to local anesthestic
  • chronic pain and/or chronic use of opioids with a daily use of over 30mg oxycodone or equivalent per day
  • contraindication to a component of multimodal analgesia
  • preexisting neuropathy with motor or sensory deficits in the area of the anterolateral chest wall
  • infection near the injection site
  • pregnancy
  • BMI >35
  • complication or adverse events unrelated to the study intervention that precludes evaluation of the primary and secondary outcomes

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serratus Block Group
Patients will receive a preoperative ultrasound-guided serratus block with 0.4ml/kg (max.30ml) of ropivacaine 0.5% with 1:4000,000 epinephrine injected between the serratus anterior (superficial) and external intercostal (deep) muscles followed by subsequent general anesthesia
Procedure: Serratus Block
Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles
Drug: ropivacaine
Drug indicated for regional anesthesia
Other Names:
  • Naropin HCL
Drug: epinephrine
Drug indicated to prolong the action of regional anesthesia
Other Names:
  • Adrenaline Chloride
Placebo Comparator: Placebo Block - Control Group
Patients will receive a preoperative placebo injection with a subcutaneous injection of 1ml normal sterile saline solution in the midaxillary line and the ultrasound probe will be used to simulate the pressure and block duration associated with the serratus block. These patients will then receive general anesthesia.
Procedure: Placebo Block
Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line
Other Names:
  • Control Group - Placebo Comparator
Other: sterile saline
Neutral injection (no drug involved)
Other Names:
  • Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain scores
Time Frame: Scores collected @ 3 different time points: admission to phase I recovery (PACU), admission to phase II recovery (day surgery unit), and discharge from day surgery unit The total time time is estimated to be up to 6 hours..
The patient's level of pain in the postoperative period will be evaluated by the use of a 100mm Visual Analogue Scale (VAS). The mean of these scores at the 3 different time points will be calculated.
Scores collected @ 3 different time points: admission to phase I recovery (PACU), admission to phase II recovery (day surgery unit), and discharge from day surgery unit The total time time is estimated to be up to 6 hours..

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative opioid consumption
Time Frame: Duration of actual surgical procedure
Duration of actual surgical procedure
Post-operative opioid consumption
Time Frame: End of surgical procedure until 7 days after surgery
End of surgical procedure until 7 days after surgery
Duration phase I and phase II recovery
Time Frame: Admission to phase I recovery (PACU) until discharge from phase II recovery, total time is estimated up to 6 hours,
Duration of stay in PACU and in surgical day care
Admission to phase I recovery (PACU) until discharge from phase II recovery, total time is estimated up to 6 hours,
Opioid side-effects
Time Frame: End of surgical procedure to 7 days following surgery
Opioid-related side effects (nausea, vomiting, pruritis)
End of surgical procedure to 7 days following surgery
Block-related side-effects
Time Frame: Completion of block to 3 months postoperatively
Presence/absence of block-related side effects such as bruising, infection, systemic toxicity, persistent numbness or shoulder weakness
Completion of block to 3 months postoperatively
Satisfaction with analgesia
Time Frame: End of surgical procedure to 3 months postoperatively
Scale of 0-10 (0=Not Satisfied, 10=Very Satisfied)
End of surgical procedure to 3 months postoperatively
Quality of recovery score (QoR)
Time Frame: Discharge from hospital until 24 hours post-op
Completion of questionnaire (QoR) done by patient.
Discharge from hospital until 24 hours post-op
Pain assessment
Time Frame: Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response.
Persistent postsurgical pain
Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response.

Collaborators and Investigators

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

Sponsor

Women's College Hospital

Investigators

  • Principal Investigator: Richard Brull, MD FRCP, Women's College Hospital

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)

October 29, 2014

Primary Completion (Actual)

September 11, 2019

Study Completion (Actual)

December 11, 2019

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 25, 2015

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0051-E

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.

Clinical Trials on Anesthesia

Clinical Trials on Serratus Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe