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NCT Number: NCT07279727

Ultrasound-Guided Infraclvicular Block Using Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Upper Limb Orthopedic Surgery

this study is designed to evaluate and compare the efficacy of dexmedetomidine and nalbuphine as adjuvants to 0.5% bupivacaine in ultrasound-guided infraclavicular brachial plexus block for patients undergoing elective upper limb orthopedic surgeries on the duration of analgesia.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of medicine Assiut University, Assiut,

Asyut, Asyut Governorate, Egypt

Location contact

Momen mostafa meki, Dr

CONTACT

[email protected]

01223344886 ext. 088

About this study

Regional anesthesia is an integral component of modern anesthetic practice. It provides high-quality surgical anesthesia and superior postoperative analgesia while avoiding airway manipulation, minimizing systemic opioid use, and facilitating early ambulation and discharge .

Compared with general anesthesia, regional techniques reduce postoperative pain scores, nausea, and opioid requirements, leading to faster recovery and higher patient satisfaction. They are especially valuable in orthopedic upper-limb surgeries where prolonged postoperative analgesia is desired.

For upper limb procedures, various brachial plexus approaches-interscalene, supraclavicular, infraclavicular, and axillary-are utilized depending on the surgical site. Ultrasound guidance has greatly improved the safety and success rates of these blocks by allowing direct visualization of the nerves, needle, and spread of local anesthetic (LA).

The infraclavicular approach targets the cords of the brachial plexus surrounding the axillary artery in the infraclavicular fossa. It provides dense anesthesia and analgesia for surgeries of the elbow, forearm, and hand. Advantages over the supraclavicular or axillary approaches include reliable blockade of the musculocutaneous, median, ulnar, and radial nerves with a single injection, Lower risk of pneumothorax or phrenic nerve palsy and better catheter stability for continuous analgesia .

Despite these benefits, the main limitation is the finite duration of analgesia when using local anesthetics alone. Adjuvants have been explored to extend block duration and enhance quality without increasing toxicity. Commonly used agents include opioids, clonidine, dexmedetomidine, magnesium sulfate, dexamethasone, and others.

Dexmedetomidine is a highly selective α₂-adrenergic receptor agonist with sedative, anxiolytic, and analgesic properties and minimal respiratory depression.

It acts centrally through activation of α₂ receptors in the locus coeruleus inhibits norepinephrine release, producing sedation (Brummett et al., 2009) , and has peripheral action through hyperpolarization of C and Aδ nerve fibers via inhibition of sodium and potassium channels prolongs the effect of local anesthetics.

The addition of Dexmedetomidine as adjuvant to local bupivacaine in regional anesthesia has proven to : Shortens onset time of sensory and motor block, Prolongs block duration and postoperative analgesia by 3-6 hours, Reduces rescue analgesic consumption, and Provides mild sedation without respiratory depression.

However, potential adverse effects include bradycardia and hypotension related to systemic absorption, particularly at higher doses.

Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist that acts predominantly as a κ-receptor agonist and µ-receptor antagonist. This pharmacologic profile provides potent analgesia with limited risk of respiratory depression, pruritus, or nausea commonly associated with pure µ-agonists such as morphine or fentanyl.

When used as an adjuvant to local anesthetics, nalbuphine is thought to: Prolong sensory and motor block duration, increase postoperative analgesia, Reduce opioid consumption, and has Minimal side effects . it produce its effects through acting on opioid receptors located on peripheral sensory nerve endings and by reducing inflammatory mediator release.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adults aged 18-65 years ASA I-II (American Society of Anesthesiologists physical status classification) Scheduled for elective upper limb orthopedic surgeries Able to provide informed consent to participate in the study

Exclusion criteria

Refusal to participate in the study Pregnancy Allergy to any study drug(s) Neurological disease (e.g., neuropathies, central nervous system disorders) Coagulopathy or active bleeding disorders Severe systemic diseases (e.g., uncontrolled cardiovascular, renal, or liver disease) Opioid abuse or history of substance use disorder

Treatment and study plan

Nalbuphine

Drug

Nalbuphine will be added to .5% bupivacaine as an adjuvant in infraclavicular nerve block

Dexmedetomidine

Drug

Dexmedetomidine will be added to .5% bupivacaine as an adjuvant in infraclavicular nerve block

Other names: precedex

Primary outcomes

  1. Our primary outcome of this study will be: Duration of Analgesia.

    Time frame: till 24 hour postoperative

    Definition: The time interval (in minutes) between the completion of the infraclavicular block injection and the first request for rescue analgesia (VAS ≥ 3).

    Scale: Visual Analog Scale (VAS)

    Scale Title: Visual Analog Scale for Pain (VAS)

    Minimum Value: 0 (no pain)

    Maximum Value: 10 (worst possible pain)

    Interpretation: Higher VAS scores indicate worse pain, and a score of ≥ 3 indicates the need for rescue analgesia.

Secondary outcomes

  1. Onset time of sensory and motor block

    Time frame: till 20 minute after the block

  2. Duration of sensory and motor block

    Time frame: 20 minute after the block

  3. Time to first rescue analgesic request

    Time frame: till 24 hour postoperative

  4. Heart rate (HR)

    Time frame: till 24 hour postoperative

  5. Mean arterial blood pressure (MAP)

    Time frame: 24 hour postoperative

Study contacts

Contact information is provided by the study sponsor or research team.

Hossam El-din Gamal Fakhry, Dr.

CONTACT

[email protected]

01026269773 ext. 088

Momen mostafa meki, dr

CONTACT

[email protected]

01223344886 ext. 088

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ultrasound-Guided Infraclvicular Block Using Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Upper Limb Orthopedic Surgery: A Prospective, Randomized, Double-Blind Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Dec 12, 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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