Serratus Plane Block vs Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery

Comparison of the Effects of Serratus Plane Block and Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery

Interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. In this study, we aimed to compare the effects of serratus plane block (SPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Postoperative Pain
• Intervention / Treatment: Drug: Bupivacaine Injection

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I-II
• Age: 18 - 65 years
• unilateral breast surgery

Exclusion Criteria:

• Does not approve the study
• Pregnant
• Emergency
• ASA III-IV
• History of local anesthetic allergy
• Infection in the block area
• Coagulation disorder
• Morbid obesity (body mass index> 40 kg / m²)
• Severe organ failure
• Previous neurological deficit
• Psychiatric disease
• History of chronic pain

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group S; Serratus plane block with 25 ml %0.25 bupivacaine	Drug: Bupivacaine Injection; Block with bupivacaine
Active Comparator: Grup E; Erector spinae plane block with 25 ml %0.25 bupivacaine	Drug: Bupivacaine Injection; Block with bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score	Visual analog scale (0-10), <4 is adequate analgesia	Postoperative 24 hours
Postoperative tramadol consumption	Postoperative opiodi consumption with patient controlled analgesia	Postoperative 24 hours
Rescue analgesic	If VAS score is 4 or more, paracetamol 1 gr is administered	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia time	Time from block performing to first analgesia requirement	Procedure

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): September 29, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: serratus plane block, erector spinae plane block, postoperative analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: KS01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No