Clinical trial
Comparison of the Effects of Dexamethasone and magnesıum Sulphate Used as Adjuvant in Infraclavicular Brachial Plexus Nerve Block.
Name
03.03.2022/03
Description
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.
Trial arms
Trial start
2023-01-02
Estimated PCD
2023-01-02
Trial end
2023-07-20
Status
Completed
Treatment
Bupivacaine + dexamethasone
Vital signs were recorded before the block. Peripheral vascular access was established with a 20-gauge catheter and 0.9% NaCl crystalloid solution infusion was started. For sedation, all patients were routinely administered 1mg midazolam intravenously before the procedure. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), 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.
Arms:
Group Group B+D (bupivacaine + dexamethasone group) (n= 30)
Other names:
Group B+D
Bupivacaine + magnesium sulphate
Vital signs were recorded before the block. Peripheral vascular access was established with a 20-gauge catheter and 0.9% NaCl crystalloid solution infusion was started. For sedation, all patients were routinely administered 1mg midazolam intravenously before the procedure. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), 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.
Arms:
Group B+M (bupivacaine + magnesium group) (n= 30)
Other names:
Group B+M
bupivacaine
bupivacaine
Arms:
Group B (bupivacaine) (n= 30)
Size
90
Primary endpoint
Motor block onset time
24 hours
Motor Block Duration
24 hours
Sensory block onset time
24 hours
Sensory block duration
24 hours
VAS score
24 hours
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': "The required asepsis in the area where the block would be applied was provided with 10% poviodine iodine and covered with a sterile drape. The USG probe was placed in the sagittal plane 1 cm below the intersection point between the coracoid process and the clavicle, and after visualizing the lateral, posterior and medial cords around the axillary artery, a peripheral nerve block needle was directed towards the 8 o'clock position relative to the axillary artery, in the same plane as the USG probe. When the expected distal motor response was obtained, the current of the peripheral nerve stimulator was reduced to 0.3 mA to avoid intraneural injection. If the motor response disappeared, local anesthetic was injected slowly. Sensory and motor block onset times, saturation, systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate peak values at the 0th, 15th, 30th and 60th minutes after the block were recorded.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2023-10-17
1 organization
Organization
Yuzuncu Yıl University