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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07081581
Enrollment
75
Registered
2025-07-23
Start date
2022-08-01
Completion date
2023-03-01
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Post Operative Pain

Keywords

pain management, serratus anterior plane block, Breast cancer surgery

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.

Detailed description

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.

Interventions

DRUGBupivacain

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

DRUGBupivacaine and Magnesium sulfate

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

DRUGBupivacaine and Dexmedetomidine ile Blokaj

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

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

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

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Postoperative analgesic efficacyuntil the 24th hour postoperativelyHemodynamic 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

MeasureTime frameDescription
Complications due to adjuvant agentsuntil the 24th hour postoperativelyComplications due to adjuvant agents used in serratus plan blockade

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026