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Completed

NCT Number: NCT06085417

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

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Key information

Conditions

Bupivacaine Adjuvant Dexamethasone Magnesıum Sulphate

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haci Yusuf GUNES

Van, 65080, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine + Dexamethasone

Drug

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

Bupivacaine + magnesium sulphate

Drug

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

Bupivacaine

Drug

bupivacaine

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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