Skip to main content
OpenTrials
Completed

NCT Number: NCT04908878

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ultrasound-Guided Bites and Stings Chemically-Induced Disorders Modified Radical Mastectomy Pectoral Nerve (PECS) Block Poisoning Serratus Anterior Plane Block Transeversus Thoracic Plane Blocks Wounds and Injuries

Age range

21 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Tanta University

Tanta, Elgharbia, 31527, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Patient refusal.
  • Known hypersensitivity to local anesthetics.
  • Body mass index > 35 kg /m2.
  • Uncooperative or psychiatric patients.
  • Infection at the injection site.
  • Coagulation disorder.

Treatment and study plan

Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block

Procedure

Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.

Serratus anterior plane (SAP) block

Procedure

Patients will receive US-guided SAP block after induction of general anesthesia.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2021
Registry last updated
Nov 29, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.