Analgesic Effect of Serratus Plane Block With Adjuvant Agents in Breast Cancer Surgery

NCT07081581 | Completed Phase 2 DMC

• 1 other identifier: SBU-ANESTEZİ-DMY-03
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after breast surgery has been described as moderate to severe in intensity and, if inadequately treated, increases postoperative morbidity, hospital cost, and the incidence of persistent postoperative pain. Serratus anterior plane block is an interfascial injection technique for analgesia of the chest wall. The aim of this study was to investigate the effect of magnesium and dexmedetomidine as adjuvant agents on postoperative analgesia in serratus anterior plane block in patients undergoing modified radical mastectomy.

Conditions

Breast Cancer; Post Operative Pain

Keywords

pain management; serratus anterior plane block; Breast cancer surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative analgesic efficacy

  Hemodynamic parameters (heart rate, noninvasive mean arterial blood pressure, peripheral oxygen saturation), numerical rating scale (NRS) scores, number of tramadol uses with patient-controlled analgesia device, and additional analgesic drug consumption were recorded at 2, 6, 12, and 24 hours after surgery. The Numerical Rating Scale (NRS) is a subjective scale in which patients rate their pain intensity by selecting a number between 0 and 10. 0 means "no pain," while 10 means "worst pain imaginable." Patients typically rate their pain over the past 24 hours. It can be used in both verbal and written formats.

  until the 24th hour postoperatively

Secondary Outcomes (1)

• Complications due to adjuvant agents

  until the 24th hour postoperatively

Study Arms (3)

Group B

EXPERIMENTAL

Group B (Blockade with Bupivacaine): 30 mL bupivacaine (0.25%)

Drug: Bupivacain

Group M

EXPERIMENTAL

Group M (Bupivacaine+Magnesium Blockade): 30 mL bupivacaine (0.25%) + 500 mg magnesium sulphate

Drug: Bupivacaine and Magnesium sulfate

Group D

EXPERIMENTAL

Group D (bupivacaine + dexmedetomidine ile Blokaj): 30 mL bupivacaine (% 0.25) + 1 μg/kg dexmedetomidine.

Drug: Bupivacaine and Dexmedetomidine ile Blokaj

Interventions

Bupivacain DRUG

In Group B( control group), bupivacaine was given as additional medication in the serratus block application.

Also known as: Control group

Group B

Bupivacaine and Magnesium sulfate DRUG

In Group M, bupivacaine and magnesium were given as additional medication in the serratus block application.

Also known as: Local anesthetic with added adjuvant agent(1)

Group M

Bupivacaine and Dexmedetomidine ile Blokaj DRUG

In Group D, bupivacaine and dexmedetomidine were given as additional medication in the serratus block application.

Also known as: Local anesthetic with added adjuvant agent(2)

Group D

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Not hypersensitive to the drugs to be used in the study or to the substances contained in them,
• No infection or anatomical deformation at the site of intervention,
• No antithrombotic treatment and normal coagulation parameters,
• Patients who have the consent of themselves or one of their legal guardians.

You may not qualify if:

• Less than 30 years of age, older than 70 years of age or ASA (American Society of Anaesthesiologists) Classification IV,
• Receiving antithrombotic therapy with abnormal coagulation parameters,
• Infection or anatomical abnormality at the blockage site,

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Agnosia

Interventions

Bupivacaine; Control Groups; Magnesium Sulfate; Anesthetics, Local

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Dilek MD Metin Yamac

  Sultan Abdülhamid Han education and research hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Drugs administered in regional blocks were prepared according to group randomisation by an anaesthetist not involved in patient management or data collection. Patients were divided into three groups using a sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist doctor

Model Details: After induction of general anaesthesia, serratus anterior plane block was performed in all patients. Group B received bupivacaine (control group), Group D received bupivacaine + dexmedetomidine, Group M received bupivacaine + magnesium sulphate.

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: July 23, 2025
• Study Start: August 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)