Skip to main content
OpenTrials
Completed

NCT Number: NCT07081581

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

About this study

In this prospective, double-blind, randomised controlled study, a total of 75 patients aged 30-70 years, who were planned for elective modified radical mastectomy after ethics committee approval, were included. Patients were randomly divided into three groups. After induction of general anaesthesia, serratus anterior plane block was applied to all patients. Group B received bupivacaine 30 ml (0.25%), Group D received bupivacaine 30 ml (0.25%) + dexmedetomidine 1μg/kg, Group M received bupivacaine 30 ml (0.25%) + 500 mg magnesium sulphate. Haemodynamic parameters, numerical rating scale (NRS) scores, number of tramadol use with patient-controlled analgesia device, additional analgesic drug consumption and side effects were recorded at 2, 6, 12 and 24 hours postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

- 30-70 years old, ASA I-II-III patient group,

  • 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.

Exclusion criteria

  • 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,

Treatment and study plan

Bupivacain

Drug

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

Other names: Control group

Bupivacaine and Magnesium sulfate

Drug

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

Other names: Local anesthetic with added adjuvant agent(1)

Bupivacaine and Dexmedetomidine ile Blokaj

Drug

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

Other names: Local anesthetic with added adjuvant agent(2)

Primary outcomes

  1. Postoperative analgesic efficacy

    Time frame: until the 24th hour postoperatively

    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.

Secondary outcomes

  1. Complications due to adjuvant agents

    Time frame: until the 24th hour postoperatively

    Complications due to adjuvant agents used in serratus plan blockade

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Comparison of the Postoperative Analgesic Efficacy of Serratus Plane Block With Different Adjuvant Agents in Breast Cancer Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

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.