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Completed

NCT Number: NCT06020781

Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block

The study aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives in ultrasound-guided supraclavicular brachial plexus block for anesthesia.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence, a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologist (ASA) grade I or II patients
  • both sexes
  • scheduled for elective upper limb surgery below mid-humerus level under Ultrasound -guided Supraclavicular brachial plexus block .

Exclusion criteria

  • with pre-existing peripheral neuropathy of upper limb.
  • Bleeding disorders.
  • Infection at injection site.
  • Untreated pneumothorax.
  • Patients on adrenoreceptor agonist or antagonist therapy.
  • History of severe cardiac,.respiratory, hepatic, or renal disease.
  • pregnancy and known hypersensitivity to the study drugs.

Treatment and study plan

bupivacaine and dexmedetomidine.

Drug

patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.

Bupivacaine Only

Drug

patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives

Bupivacaine

Drug

patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.

Primary outcomes

  1. Success rate.

    Time frame: 30 minutes after block performance

    Sensory and motor block evaluation will be done every 3 min after giving the block until complete sensory and motor block or 30 min, whichever will be earlier.

Secondary outcomes

  1. Total pethidine consumption.

    Time frame: 24 hours postoperative.

    Visual analog scale ≥ 4 indicates the analgesic requirements. The patient will be given supplementary pethidine I.V. injection in a dose of 0.5 mg as rescue analgesia. Total pethidine consumption postoperative in the 1st 24 hours will be measured.

  2. Pain score.

    Time frame: 24 hours postoperative.

    Pain score will be measured by visual analogue scale (VAS) at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours postoperative.

    The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).

  3. Mean arterial blood pressure

    Time frame: From preoperatively till the end of surgery

    Mean arterial blood pressure from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.

  4. Heart rate

    Time frame: From preoperatively till the end of surgery

    Heart rate from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.

  5. Postoperative side effects.

    Time frame: 24 hours postoperative

    Complication related to the block or adverse events of the administered drugs.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Efficacy and Safety of Dexmedetomidine to 20ml Bupivacaine in Supraclavicular Brachial Plexus Block

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 1, 2023
Registry last updated
Apr 2, 2024

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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