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Clinical Trials/NCT06611644
NCT06611644
Completed
Not Applicable

A Comparative Analysis of Erector Spinae Plane (ESP) Block and Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Breast Surgery

Çanakkale Onsekiz Mart University1 site in 1 country75 target enrollmentJuly 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Surgery
Sponsor
Çanakkale Onsekiz Mart University
Enrollment
75
Locations
1
Primary Endpoint
Postoperative Opioid Consumption
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aims to compare the efficacy of the ESP and SPSIP blocks in managing postoperative pain following breast surgery. Breast surgery, particularly after oncological and reconstructive procedures, often leads to significant postoperative pain. Effective pain control is crucial for accelerating recovery, reducing the risk of complications, and facilitating early discharge. Both ESP and SPSIP blocks involve the administration of local anesthetics into fascial plane spaces to achieve peripheral nerve blockade and control pain. This study will evaluate the effectiveness of these blocks in terms of pain scores, opioid consumption, and overall patient satisfaction to determine the optimal approach for postoperative pain management in breast surgery.

Detailed Description

Breast surgery is one of the most frequently performed procedures, and effective postoperative pain management is critical to its success. Proper pain control not only facilitates early mobilization but also reduces the risks of pulmonary complications, deep vein thrombosis, and embolism. It helps prevent stress-induced endocrine and metabolic responses, shortens hospital stays, and lowers healthcare costs. Regional anesthesia is a highly effective strategy for postoperative pain control, minimizing opioid use and its associated side effects such as sedation, nausea, vomiting, and constipation. Among the commonly used regional anesthesia techniques in breast surgery are the Erector Spinae Plane (ESP) block, Serratus Anterior Plane block, and Pectoral block. While the ESP block appears more effective, conflicting evidence exists regarding its efficacy in postoperative pain management, with variability in block spread across individuals. The recently introduced Serratus Posterior Superior Intercostal Plane (SPSIP) block, a periparavertebral block, offers a wider distribution range from C3 to T7 dermatomes, suggesting potential for more comprehensive postoperative analgesia in breast procedures. The ESP block is performed under ultrasound guidance, using an in-plane technique to advance the needle from caudal to cranial (or vice versa), targeting the lateral part of the T6 transverse process, where local anesthetic is injected between the erector spinae muscle and the transverse process. For the SPSIP block, the needle is advanced between the second and third ribs towards the medial scapula, reaching the fascial plane between the serratus posterior superior muscle and the intercostal muscles. After hydrodissection confirms placement, local anesthetic is injected. This study aims to compare the efficacy of ESP and SPSIP blocks in managing postoperative pain in breast surgery by evaluating pain scores, opioid consumption, and patient satisfaction. Since no study has yet directly compared these blocks, the findings will make a significant contribution to the existing literature.

Registry
clinicaltrials.gov
Start Date
July 6, 2024
End Date
January 16, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Çanakkale Onsekiz Mart University
Responsible Party
Principal Investigator
Principal Investigator

Mihrican SAYAN

Specialist

Çanakkale Onsekiz Mart University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Postoperative Opioid Consumption

Time Frame: 24 hours

Postoperative opioid consumption will be monitored using a Patient-Controlled Analgesia (PCA) device, which will be connected to each patient at the end of surgery. The PCA settings will be 2 mg/cc tramadol solution, with no basal infusion, a lockout time of 20 minutes, and a 10 mg bolus dose. The total opioid (tramadol, Unit: miligram) consumption over 24 hours will be recorded, including the number of times the patient required analgesia and the number of bolus doses administered by the device.

Numeric Rating Scale (NRS)

Time Frame: 24 hours postoperatively (measured at 0, 2, 6, 12, and 24 hours)

Pain intensity will be assessed using the Numeric Rating Scale (NRS), where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). NRS scores will be recorded to evaluate postoperative pain levels in each group at specific intervals.

Secondary Outcomes

  • Verbal Descriptive Nausea and Vomiting Scale(24 hours postoperatively (measured at 0, 2, 6, 12, and 24 hours))
  • Patient Satisfaction(24 hours postoperatively)
  • Length of Hospital Stay(Up to 1 week postoperatively (measured in hours))

Study Sites (1)

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