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

Dexamethasone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06085417
• Other study ID #: 03.03.2022/03
• Status: Completed
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: July 20, 2023

Study information

• Verified date: October 2023
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 20, 2023
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjuvant
• Bupivacaine
• Dexamethasone
• Magnesium Sulphate

Intervention

Drug:
• 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.
• 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.
• bupivacaine
bupivacaine

Locations

Country	Name	City	State
Turkey	Haci Yusuf GUNES	VAN

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor block onset time	Motor block examination was performed with the modified Bromage scale. In the motor block examination, thumb orientation was examined for the median nerve, thumb abduction for the radial nerve, thumb adduction for the ulnar nerve, and elbow flexion for the musculocutaneous nerve. Patients with a modified Bromage scale = 2 on the side where the block was applied were considered to have a successful block and the patient's surgery was initiated.	24 hours
Primary	Motor Block Duration	Motor block durations were determined according to the Bromage scales at the 1st, 3rd, 6th, 12th and 24th postoperative hours.	24 hours
Primary	Sensory block onset time	Pinprick sensory test was used in the sensory examination of the patients. Sensory examination was performed using a pinprick test on the first 3 fingers and the dorsal side of the wrist for the radial nerve, the medial side of the 5th finger for the ulnar nerve, the first 3 fingers and the volar side of the wrist for the median nerve, and the lateral region of the forearm for the musculocutaneous nerve.Pinprick sensory test = 1 on the side where the block was applied were considered to have a successful block and the patient's surgery was initiated.	24 hours
Primary	Sensory block duration	Sensory block durations were determined according to the Pinprick sensory test at the 1st, 3rd, 6th, 12th and 24th postoperative hours.	24 hours
Primary	VAS score	VAS scores at the 1st, 3rd, 6th, 12th and 24th postoperative hours were evaluated. Dexketoprofen trometamol 50 mg was given intravenously to patients with a postoperative VAS Score of 4 and above. If the VAS Score was 6 or above even though NSAIDs were administered, the patients were given the opioid analgesic tramadol hydrochloride 1 mg/kg intravenously.	24 hours