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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453516
• Other study ID #: 2014-0051-E
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 29, 2014
• Est. completion date: December 11, 2019

Study information

• Verified date: January 2020
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 11, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Serratus Block
Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles
• Placebo Block
Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line

Drug:
• ropivacaine
Drug indicated for regional anesthesia
• epinephrine
Drug indicated to prolong the action of regional anesthesia

Other:
• sterile saline
Neutral injection (no drug involved)

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain scores	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	Intraoperative opioid consumption		Duration of actual surgical procedure
Secondary	Post-operative opioid consumption		End of surgical procedure until 7 days after surgery
Secondary	Duration phase I and phase II recovery	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,
Secondary	Opioid side-effects	Opioid-related side effects (nausea, vomiting, pruritis)	End of surgical procedure to 7 days following surgery
Secondary	Block-related side-effects	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
Secondary	Satisfaction with analgesia	Scale of 0-10 (0=Not Satisfied, 10=Very Satisfied)	End of surgical procedure to 3 months postoperatively
Secondary	Quality of recovery score (QoR)	Completion of questionnaire (QoR) done by patient.	Discharge from hospital until 24 hours post-op
Secondary	Pain assessment	Persistent postsurgical pain	Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response.