Combined PECS II and Transeversus Thoracic Plane Blocks Vs Serratus Anterior Plane Block in Modified Radical Mastectomy

November 28, 2022 updated by: Alshaimaa Soliman Alasrag, Tanta University

Analgesic Efficacy of Combined Ultrasound-Guided PECS II and Transeversus Thoracic Plane Blocks Versus Ultrasound-Guided Serratus Anterior Plane Block in Modified Radical Mastectomy: A Prospective Randomized Study

The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elgharbia
      • Tanta, Elgharbia, Egypt, 31527
        • Faculty of medicine Tanta university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients
  • Aged 21-60 years
  • ASA physical status I, II
  • Scheduled for unilateral modified radical mastectomy

Exclusion Criteria:

  1. Patient refusal.
  2. Known hypersensitivity to local anesthetics.
  3. Body mass index > 35 kg /m2.
  4. Uncooperative or psychiatric patients.
  5. Infection at the injection site.
  6. Coagulation disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group I (pectoral nerve (PECS) block -transversus thoracic plane (TTP) block group)
Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.
Procedure: Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block
Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.
EXPERIMENTAL: Group II (serratus anterior plane (SAP) block group)
Patients will receive US-guided SAP block after induction of general anesthesia.
Procedure: Serratus anterior plane (SAP) block
Patients will receive US-guided SAP block after induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively.
Time Frame: First 24 hours postoperatively.
Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.
First 24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The degree of postoperative pain
Time Frame: First 24 hours postoperatively.

Postoperative pain will be assessed by Visual Analog scale (VAS) on admission to Post-Anesthesia Care unit (PACU) and at 30 minutes and then 1,2,4,6,12,18 and 24 hours postoperative.

VAS (0-100; where 0 represents no pain and 100 represents the worst pain).
First 24 hours postoperatively.
Time to first rescue analgesia request.
Time Frame: First 24 hours postoperatively.
Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.
First 24 hours postoperatively.
Intraoperative fentanyl consumption.
Time Frame: Intraoperative
Additional boluses of fentanyl 0.5 µg /kg will be administered in case of inadequate analgesia that defined as increase of heart rate (HR) and /or mean arterial blood pressure (MAP) more than 20 % from baseline
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2021

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

June 2, 2022

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (ACTUAL)

June 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33972/7/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon reasonable request.

IPD Sharing Time Frame

one year

IPD Sharing Access Criteria

The data will be available upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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