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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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

Study Groups

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Group B

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

Group Type EXPERIMENTAL

Bupivacain

Intervention Type DRUG

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

Group M

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

Group Type EXPERIMENTAL

Bupivacaine and Magnesium sulfate

Intervention Type DRUG

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

Group D

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

Group Type EXPERIMENTAL

Bupivacaine and Dexmedetomidine ile Blokaj

Intervention Type DRUG

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

Interventions

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Bupivacain

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

Intervention Type DRUG

Bupivacaine and Magnesium sulfate

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

Intervention Type DRUG

Bupivacaine and Dexmedetomidine ile Blokaj

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

Intervention Type DRUG

Other Intervention Names

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Control group Local anesthetic with added adjuvant agent(1) Local anesthetic with added adjuvant agent(2)

Eligibility Criteria

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Inclusion Criteria

* 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,

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No