Comparison of the Effects of Dexamethasone and magnesıum Sulphate Used as Adjuvant in Infraclavicular Nerve Block.

Yuzuncu Yıl University

Status: Completed

Conditions: Bupivacaine; Magnesıum Sulphate; Adjuvant; Dexamethasone

Treatments: Drug: bupivacaine; Drug: Bupivacaine + dexamethasone; Drug: Bupivacaine + magnesium sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT06085417

03.03.2022/03

Details and patient eligibility

About

The aim of this prospective clinical study is to compare the effectiveness of dexamethasone and magnesium sulfate added as adjuvants to bupivacaine in infraclavicular brachial plexus block used under ultrasound guidance for upper extremity surgeries.

Full description

This study was conducted on 90 patients who underwent upper extremity surgery under infraclavicular brachial plexus block.

90 patients included in the study were randomized into 3 groups of 30 people each by the sealed envelope method.

30 participants were included in Group Bupivacaine, 30 participants were included in Group Bupivacaine + Dexamethasone and 30 participants were included in Group Bupivacaine + Magnesium sulfate.

The study was started as double blind. According to the local anesthetic used, patients were group B (30 patients, 20 cc 0.5% bupivacaine + 5 cc 0.9% NaCl), group B+D (30 patients, 20 cc 0.5% bupivacaine + 4 mg dexamethasone + 4 cc 0.9% NaCl), group They were divided into three groups as B+M (30 patients, 20 cc 0.5% bupivacaine + 150 mg magnesium sulfate + 4 cc 0.9% NaCl).

Complications of the patients, such as sensory block and motor block onset times, peroperative hemodynamic parameters, need for additional analgesia, postoperative block duration, analgesia duration, opioid and NSAID consumption, nausea and vomiting, were recorded

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants providing informed written and verbal consent
• 18-65 years old
• ASA I-II
• Cases undergoing elective upper extremity surger

Exclusion criteria

• Cases that do not accept regional anesthesia application
• Those who are under 18 years of age and over 65 years of age
• ASA III and above
• Cases in which the operation was started with infraclavicular block and then transferred to general anesthesia.
• Those with liver and kidney dysfunction
• Those with diabetes mellitus
• Those with drug allergies
• Patients with acid-base and electrolyte disorders
• Pregnant women
• Emergency cases
• Those with neuropathic disorders
• Those with significant psychiatric and cognitive disorders or substance addiction
• Those with a history of clavicle fracture, pneumonectomy, contralateral hemidiaphragmatic paralysis, pneumothorax, phrenic or recurrent laryngeal nerve palsy.
• Cases with BMI>30 or BMI<18
• Patients in whom regional anesthesia was contraindicated (sepsis, local infection, coagulopathy, heart disease, hypovolemia) were not included in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Group B (bupivacaine) (n= 30)

Sham Comparator group

Description:

For Group B (control group), 100 mg bupivacaine hydrochloride+ isotonic saline (5ml) was administered in a total volume of 25 ml. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded. During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy.

Treatment:

Drug: bupivacaine

Group Group B+D (bupivacaine + dexamethasone group) (n= 30)

Experimental group

Description:

For Group B+D (bupivacaine + dexamethasone group), 100 mg bupivacaine hydrochloride + 4 mg dexamethasone phosphate+ isotonic saline (4 ml) was administered in a total volume of 25 ml. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded. During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy.

Treatment:

Drug: Bupivacaine + dexamethasone

Group B+M (bupivacaine + magnesium group) (n= 30)

Active Comparator group

Description:

For Group B+M (bupivacaine + magnesium group), 100 mg bupivacaine hydrochloride (20ml 0.5% marcaine aspen, turkey) + 150 mg magnesium sulfate (1ml 15% magnesium sulfate, onfarma, turkey) + isotonic saline (4 ml) was administered in a total volume of 25 ml. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded. During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy.

Treatment:

Drug: Bupivacaine + magnesium sulphate