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Completed

NCT Number: NCT02453516

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serratus Block

Procedure

Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles

Placebo Block

Procedure

Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line

Other names: Control Group - Placebo Comparator

Ropivacaine

Drug

Drug indicated for regional anesthesia

Other names: Naropin HCL

Epinephrine

Drug

Drug indicated to prolong the action of regional anesthesia

Other names: Adrenaline Chloride

sterile saline

Other

Neutral injection (no drug involved)

Other names: Sodium Chloride

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 25, 2015
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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