Regional Block for Post-mastectomy Analgesia

NCT07683416 | Not Yet Recruiting

• 1 other identifier: Breast surgery analgesia
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Analgesia

Keywords

Analgesia, Mastectomy, Nerve Block, Bupivacaine

Outcome Measures

Primary Outcomes (1)

• The total opioid consumption.

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

  The first 24 hours postoperative.

Secondary Outcomes (3)

• Time of the first rescue analgesia

  The first 24 hours postoperative.

• The static and dynamic visual analogue scale

  The first 24 hours postoperative.

• Number of participants with procedure-related adverse events

  The first 24 hours postoperative.

Study Arms (2)

Serratus-intercostal plane block

ACTIVE COMPARATOR

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; Drug: Dexmedetomidine Injection

Erector spinae plane block

ACTIVE COMPARATOR

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; Drug: Dexmedetomidine Injection

Interventions

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.

Serratus-intercostal plane block

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.

Erector spinae plane block

Dexmedetomidine Injection DRUG

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

Also known as: Precedex

Erector spinae plane block; Serratus-intercostal plane block

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (3)

• Nyima T, Palta S, Saroa R, Kaushik R, Gombar S. Ultrasound-guided erector spinae plane block compared to serratus anterior muscle block for postoperative analgesia in modified radical mastectomy surgeries: A randomized control trial. Saudi J Anaesth. 2023 Jul-Sep;17(3):311-317. doi: 10.4103/sja.sja_716_22. Epub 2023 Jun 22.

  PMID: 37601524 BACKGROUND

• Vanni G, Caiazza G, Materazzo M, Storti G, Pellicciaro M, Buonomo C, Natoli S, Fabbi E, Dauri M. Erector Spinae Plane Block Versus Serratus Plane Block in Breast Conserving Surgery: Alpha Randomized Controlled Trial. Anticancer Res. 2021 Nov;41(11):5667-5676. doi: 10.21873/anticanres.15383.

  PMID: 34732440 BACKGROUND

• Villa G, Mandarano R, Scire-Calabrisotto C, Rizzelli V, Del Duca M, Montin DP, Paparella L, De Gaudio AR, Romagnoli S. Chronic pain after breast surgery: incidence, associated factors, and impact on quality of life, an observational prospective study. Perioper Med (Lond). 2021 Feb 24;10(1):6. doi: 10.1186/s13741-021-00176-6.

  PMID: 33622393 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nahla Mohamed Amin, MD

  Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

  STUDY DIRECTOR

• Samia Mohamed Masoud, MD

  Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

  STUDY CHAIR

Central Study Contacts

Amal Hossieny Gamil Mohamed, MSc

CONTACT

01001882257; Amaalhossienyy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06