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NCT Number: NCT06949488

Efficacy of Different Medications as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries

This study is to evaluate whether addition of dexmedetomidine, dexamethasone and magnesium sulfate as adjuvants to bupivacaine in supraclavicular Brachial Plexus Blockade (BPB) for pain management assessed by VAS score.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Upper Limb Surgery Brachial Plexus Blockade

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculity of medicine - Al-Azhar University hospitals

Cairo, Cairo Governorate, 11884, Egypt

About this study

This is a randomized controlled study involving 105 participants divided into three groups to assess the efficacy of adding dexmedetomidine, dexamethasone, and magnesium sulfate as adjuvants to bupivacaine in supraclavicular brachial plexus blockade during upper limb surgeries. The primary outcome is the postoperative Visual Analog Scale (VAS) score. The secondary outcomes are assessment of onset and duration of the block, patient satisfaction, and adverse effects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) status of I and II
  • undergoing forearm surgeries

Exclusion criteria

  • coagulopathies
  • Local skin lesions
  • Pregnancy
  • Has a history of significant neurological, psychiatric, or neuromuscular disorders
  • Patients refusing participation
  • BMI > 40
  • Patient with COPD. hypersensitivity or allergies to local anesthesia

Treatment and study plan

Group A (DT): Dexmedetomidine group

Procedure

The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 100 µg Dexmeditomidine and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

Group B (MG): Magnesium group

Procedure

The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 150 mg of magnesium sulfate and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

Group C (DM): Dexamethasone group

Procedure

The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 8 mg dexamethasone and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

Primary outcomes

  1. -Post operative Visual analogue scale VAS score

    Time frame: Over 24 hours post operative starting from transeferring the patient to the recovery area.

    Assess post-operative VAS score at: T0 (after transferring to the recovery area), at T1: at two hours, T3: at four hours, T4: at six hours, T5: at eight hours, T6: at 10 hours, T7: at 12 hours, T8: at 16 hours, T9: at 20 hours, and T10 at 24 hours postoperatively.

Secondary outcomes

  1. Onst of sensory block

    Time frame: Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes

    Time in minutes from completing the block to complete sensory loss to sensation of a cold cotton pad relative to the contralateral limb.

  2. Onset of motor block

    Time frame: Complete motor block will be assessed every 5 min up to a maximum of 30 minutes

    Time in minutes from completing the block up to the time when the patient is unable to overcome gravity relative to the contralateral arm.

  3. Duration of the sensory block

    Time frame: Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .

    Complete return of the sensation in the blocked limb relative to the contralateral arm.

  4. duration of the motor block

    Time frame: Motor power will be assessed every 4 hours till return of normal sensation up to maximum 24 hourswill be assessed every 4 hours till return of normal sensation up to maximum 24 hours

    Complete return of the motor power in the blocked limb

  5. Intraoperative mean arterial blood pressure

    Time frame: From positioning the patient to the block upto 90 minutes from removing the needle

    Mean arterial blood pressure in mmHg will be assessed at T0: baseline before patient positing for the block, at T1: just after removing the needle, at T2: at 30 minutes, T3: at 60 Minutes , and T4: at 90 minutes intraoperatively

  6. Intraoperative Pulse rate.

    Time frame: From positioning the patient to the block upto 90 minutes from removing the needle

    pulse rate per minute will be assessed at T0: baseline before patient positing for the block, at T1: just after removing the needle, at T2: at 30 minutes, T3: at 60 Minutes, and T4: at 90 minutes intraoperatively

  7. Post operative opioid consumption

    Time frame: Over 24 hours post operatively started form transferring the patient to the recovery area

    Postoperative total doses of pethidine in milligrams will be counted. For patients with a VAS score of more than 4, pethidine 50mg will be given intramuscularly.

  8. Post operative Nausea and vomiting

    Time frame: Over 24 hours post operative starting from transferring to the recovery area.

    Nausea and vomiting attacks will be recorded over 24 hours postoperatively.

  9. Postoperative transient neurologic symptoms

    Time frame: Over 48 hours post operative starting from transeferring to the recovery area.

    Dysesthesia will be assessed every 12 hours postoperatively and reported

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Efficacy of Dexmedetomidine, Dexamethasone, and Magnesium Sulphate as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries - A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

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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