Clinical trial NCT06085417: Comparison of the Effects of Dexamethasone and magnesıum Sulphate Used as Adjuvant in Infraclavicular Nerve Block.
Official title: Comparison of the Effects of Dexamethasone and magnesıum Sulphate Used as Adjuvant in Infraclavicular Brachial Plexus Nerve Block.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bupivacaine
Dexamethasone
Magnesıum Sulphate
Adjuvant
Keywords: Adjuvant
Bupivacaine
Dexamethasone
Infraclavicular brachial plexus nerve block
Magnesıum sulphate
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

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.

Primary outcomes:
measure: Motor block onset time
timeFrame: 24 hours
measure: Motor Block Duration
timeFrame: 24 hours
measure: Sensory block onset time
timeFrame: 24 hours
measure: Sensory block duration
timeFrame: 24 hours
measure: VAS score
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Haci Yusuf GUNES
Study officials:
affiliation: Van Yüzüncü Yıl University Van, Turkey
name: Haci Y GUNES, Assist.prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mirza F, Brown AR. Ultrasound-guided regional anesthesia for procedures of the upper extremity. Anesthesiol Res Pract. 2011;2011:579824. doi: 10.1155/2011/579824. Epub 2011 May 30.
citation: O'Donnell BD, Ryan H, O'Sullivan O, Iohom G. Ultrasound-guided axillary brachial plexus block with 20 milliliters local anesthetic mixture versus general anesthesia for upper limb trauma surgery: an observer-blinded, prospective, randomized, controlled trial. Anesth Analg. 2009 Jul;109(1):279-83. doi: 10.1213/ane.0b013e3181a3e721.
citation: Klaastad O, Sauter AR, Dodgson MS. Brachial plexus block with or without ultrasound guidance. Curr Opin Anaesthesiol. 2009 Oct;22(5):655-60. doi: 10.1097/ACO.0b013e32832eb7d3.