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NCT Number: NCT07683416

Regional Block for Post-mastectomy Analgesia

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Serratus-intercostal plane block

Procedure

The patients will receive an ultrasound-guided serratus-intercostal plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine.

Erector Spinae Plane Block

Procedure

The patients will receive an ultrasound-guided erector spinae plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine.

Dexmedetomidine Injection

Drug

The local anaesthetic mixture will include 0.25% bupivacaine plus 1 μg/kg dexmedetomidine.

Other names: Precedex

Primary outcomes

  1. The total opioid consumption.

    Time frame: The first 24 hours postoperative.

    The total opioid consumption (morphine) in the first 24 hours postoperative.

Secondary outcomes

  1. 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.

  2. The static and dynamic visual analogue scale

    Time frame: The first 24 hours postoperative.

    The static and dynamic visual analogue scale pain score with score 10 indicates the maximum pain and score 0 indicates no pain.

  3. Number of participants with procedure-related adverse events

    Time frame: The first 24 hours postoperative.

    Associated side effects related to the procedure as vascular or nerve injury, pneumothorax, and local anaesthetic systemic toxicity.

Study contacts

Contact information is provided by the study sponsor or research team.

Amal Hossieny Gamil Mohamed, MSc

CONTACT

[email protected]

01001882257 ext. +20

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 7, 2026

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.

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