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

October 16, 2023 updated by: Hacı Yusuf Güneş, MD, Yuzuncu Yıl University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • VAN, Turkey, 65080
        • Haci Yusuf GUNES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Group B (bupivacaine) (n= 30)

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.
Drug: bupivacaine
bupivacaine
Experimental: Group Group B+D (bupivacaine + dexamethasone group) (n= 30)
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.
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.

Other Names:
  • Group B+D
Active Comparator: Group B+M (bupivacaine + magnesium group) (n= 30)

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.
Drug: 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.

Other Names:
  • Group B+M

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor block onset time
Time Frame: 24 hours
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
Motor Block Duration
Time Frame: 24 hours
Motor block durations were determined according to the Bromage scales at the 1st, 3rd, 6th, 12th and 24th postoperative hours.
24 hours
Sensory block onset time
Time Frame: 24 hours
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
Sensory block duration
Time Frame: 24 hours
Sensory block durations were determined according to the Pinprick sensory test at the 1st, 3rd, 6th, 12th and 24th postoperative hours.
24 hours
VAS score
Time Frame: 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Investigators

  • Principal Investigator: Haci Y GUNES, Assist.prof, Van Yüzüncü Yıl University Van, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Actual)

January 2, 2023

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03.03.2022/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and statistical analysis plan will be share for other resarchers.

IPD Sharing Time Frame

6 month

IPD Sharing Access Criteria

The access can be provided via the e-mail addresses below hyusufgunes@hotmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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