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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Post Operative Pain

Treatments: Drug: Bupivacaine and Magnesium sulfate; Drug: Bupivacaine and Dexmedetomidine ile Blokaj; Drug: Bupivacain

Study type: Interventional

Funder types: Other

Identifiers

NCT07081581

SBU-ANESTEZİ-DMY-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Group B

Experimental group

Description:

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

Treatment:

Drug: Bupivacain

Group M

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine and Magnesium sulfate

Group D

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine and Dexmedetomidine ile Blokaj