Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of the Serratus Block on Pain Control After 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02453516
Recruitment Status : Recruiting
First Posted : May 25, 2015
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Women's College Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Procedure: Serratus Block Procedure: Placebo Block Drug: ropivacaine Drug: epinephrine Other: sterile saline Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study
Actual Study Start Date : October 29, 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

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 Name: Naropin HCL

Drug: epinephrine
Drug indicated to prolong the action of regional anesthesia
Other Name: 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 Name: Control Group - Placebo Comparator

Other: sterile saline
Neutral injection (no drug involved)
Other Name: Sodium Chloride




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Intraoperative opioid consumption [ Time Frame: Duration of actual surgical procedure ]
  2. Post-operative opioid consumption [ Time Frame: End of surgical procedure until 7 days after surgery ]
  3. 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

  4. Opioid side-effects [ Time Frame: End of surgical procedure to 7 days following surgery ]
    Opioid-related side effects (nausea, vomiting, pruritis)

  5. 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

  6. Satisfaction with analgesia [ Time Frame: End of surgical procedure to 3 months postoperatively ]
    Scale of 0-10 (0=Not Satisfied, 10=Very Satisfied)

  7. Quality of recovery score (QoR) [ Time Frame: Discharge from hospital until 24 hours post-op ]
    Completion of questionnaire (QoR) done by patient.

  8. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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): NCT02453516


Contacts
Layout table for location contacts
Contact: Didem Bozak 4163236400 ext 6008 didem.bozak@wchospital.ca

Locations
Layout table for location information
Canada, Ontario
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Richard Brull, MD, FRCPC    416-323-6269    richard.brull@uhn.ca   
Contact: Didem Bozak    4163236400 ext 6008    didem.bozak@wchospital.ca   
Principal Investigator: Richard Brull, MD FRCP         
Sub-Investigator: Caveh Madjdpour, MD         
Sub-Investigator: Faraj Abdallah, MD         
Sub-Investigator: Anuj Bhatia, MD, FRCPC         
Sponsors and Collaborators
Women's College Hospital
Investigators
Layout table for investigator information
Principal Investigator: Richard Brull, MD FRCP Women's College Hospital

Layout table for additonal information
Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT02453516     History of Changes
Other Study ID Numbers: 2014-0051-E
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

Keywords provided by Women's College Hospital:
Serratus Block
Breast Surgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents