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NCT Number: NCT04194320

Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block

Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of dexamethasone or nalbuphine as adjuvants to local anesthetics in supraclavicular brachial plexus block for upper limb surgeries.

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Key information

Conditions

Anesthesia

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Zagazig University

Zagazig, Al-Sharkia, 055, Egypt

About this study

Upper-limb surgeries can be performed under either general or regional anesthesia.However, regional anesthesia has the advantages of long-lasting pain relief & avoidance of airway instrumentation.Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to local anesthetics mixture (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in Ultrasound-guided supraclavicular brachial plexus block for upper limb surgeries below the level of the shoulder.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient acceptance.
  • American Society of Anesthesiologists (ASA) I and (ASA) II.
  • Age 21-60 years old.
  • Both gender.
  • BMI < 30.
  • Accepted mental state of the patient.
  • Unilateral upper limb surgeries below the level of the shoulder.

Exclusion criteria

  • Patient refusal.
  • Peripheral neuropathy.
  • Pathological coagulopathy.
  • Infection at the injection site.
  • History of active substance abuse.
  • Untreated pneumothorax.
  • Disturbed conscious level.
  • An allergy to local anesthetics or nalbuphine or dexamethasone.
  • Planned for receiving general anesthesia during the same operation for any cause.

Treatment and study plan

Ultrasound (US) guided supraclavicular brachial plexus block

Procedure

Using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in ultrasound (US) guided supraclavicular brachial plexus block

Primary outcomes

  1. Duration of postoperative analgesia

    Time frame: First 24 hours after surgery

    Time between onset of sensory block to the first report of postoperative pain at the surgical site that has a VAS "visual analogue score" ≥ 4.

Secondary outcomes

  1. post operative pain score "Visual Analogue Score"

    Time frame: First 24 hours after surgery

    On a scale of 0-10, the patient will be asked to quantify postoperative pain as the following: 0: No pain 10: Maximum/worst imaginable pain. Visual Analog Scale assessment will be done every 5 minutes for first 30 minutes, then hourly for first 8 hours then every 4 hourly till patient complained of pain equivalent to a VAS score of 4. Rescue analgesia (injection of fentanyl 25 mcg intravenous increments) up to 200 μg/hour is administered when VAS score reached 4.

  2. The total opioid consumption

    Time frame: First 24 hours after surgery

    Total dose of fentanyl as a rescue analgesic in the first 24 hours

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Nalbuphine Versus Dexamethasone as an Adjuvant to Lidocaine / Bupivacaine Mixture in Ultrasound-guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2019
Registry last updated
Oct 1, 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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