Regional Block for Post-mastectomy Analgesia

June 27, 2026 updated by: Zagazig University

Dexmedetomidine as an Adjuvant to Bupivacaine for Serratus-Intercostal Versus Erector-Spinae Plane Block to Relieve Post-Mastectomy Pain

A large number of patients undergoing major surgical procedures for the management of breast cancer complain of acute and chronic postoperative pain. Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques, such as paravertebral block and thoracic epidural anaesthesia, have possible complications and technical difficulties. So, we will discuss adding dexmedetomidine as an adjuvant to bupivacaine for serratus-intercostal versus erector-spinae plane block to relieve post-mastectomy pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Current pain management encompasses regional anaesthetic techniques and systemic administration of analgesia with a synergetic effect on pain. Regional analgesic techniques improve perioperative pain control, reduce opioid consumption and side-effects. We will investigate whether adding dexmedetomidine to bupivacaine for the serratus-intercostal plane block or the erector-spinae plane block during breast surgery could provide better intraoperative and postoperative analgesia, delay the time to first analgesic request, and reduce intraoperative and postoperative analgesic consumption.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Unilateral mastectomy operations.
  • Body mass index less than 35 kg per square meter.
  • American Society of Anesthesiologists physical status grade I-II.

Exclusion Criteria:

  • Patient refusal.
  • History of chronic pain therapy.
  • Infection at the injection site.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Serratus-intercostal plane block
The patients will receive an ultrasound-guided serratus-intercostal plane block after induction of general anaesthesia and before surgical incision.
Procedure: Serratus-intercostal plane block
The patients will receive an ultrasound-guided serratus-intercostal plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine.
Active Comparator: Erector spinae plane block
The patients will receive an ultrasound-guided erector spinae plane block after induction of general anaesthesia and before surgical incision.
Procedure: Erector spinae plane block
The patients will receive an ultrasound-guided erector spinae plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total opioid consumption.
Time Frame: The first 24 hours postoperative.
The total opioid consumption (morphine) in the first 24 hours postoperative.
The first 24 hours postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of the first rescue analgesia
Time Frame: The first 24 hours postoperative.
Time of the first rescue analgesia needed by the patient when visual analogue pain score ≥4.
The first 24 hours postoperative.
The static and dynamic visual analogue scale
Time Frame: The first 24 hours postoperative.
The static and dynamic visual analogue scale pain score.
The first 24 hours postoperative.
Associated side effects
Time Frame: The first 24 hours postoperative.
Associated side effects related to the procedure.
The first 24 hours postoperative.

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Study Director: Nahla Mohamed Amin, MD, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
  • Study Chair: Samia Mohamed Masoud, MD, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 27, 2026

First Submitted That Met QC Criteria

June 27, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 27, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Breast surgery analgesia

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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