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Regional AnaesthesiaPhase 1NCT07279727

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

A Phase 1 study testing Nalbuphine and Dexmedetomidine in people with Regional Anaesthesia, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Regional Anaesthesia
What is being tested?
Nalbuphine and Dexmedetomidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteEgypt
Study dates
1 Jan 2026to 1 Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hossam El-din Gamal Fakhry, Dr. contact

01026269773 ext. 088

hossam.hg@aun.edu.eg

Egypt1 site
  • Faculty of medicine Assiut University, Assiut,

    Asyut, Asyut Governorate

    Momen mostafa meki, Dr, 01223344886 ext. 088, moamen.meki@med.aun.edu.eg

Other trials in Egypt

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Nalbuphine, Dexmedetomidine
Keywords
Nalbuphine, Dexmedetomidine, Duration of analgesia, Bupivacaine, Infraclavicular block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NalbuphineDrug

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

  • DexmedetomidineDrug

    Also called precedex

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

Study groups in NCT07279727
Study groupRoleWhat they receive
nalbuphine groupActive comparator• Patients in group N (Nalbuphine group) will receive 29 mL of 0.5% bupivacaine + 1 mL (containing 10 mg nalbuphine)
Receives: Drug: Nalbuphine
Dexmedetomidine groupActive comparator• Patients in group D (Dexmedetomidine group) will receive 29 mL of 0.5% bupivacaine + 1mL (containing 75 µg dexmedetomidine
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: till 24 hour postoperative

Secondary outcomes (5)
  1. Onset time of sensory and motor block

    Measured: till 20 minute after the block

  2. Duration of sensory and motor block

    Measured: 20 minute after the block

  3. Time to first rescue analgesic request

    Measured: till 24 hour postoperative

  4. Heart rate (HR)

    Measured: till 24 hour postoperative

  5. Mean arterial blood pressure (MAP)

    Measured: 24 hour postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07279727
Sponsor's protocol ID
Infraclavicular nerve block
Status last verified
Nov 2025
First submitted
27 Nov 2025
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nalbuphine and Dexmedetomidine in people with Regional Anaesthesia, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Momen mostafa meki, dr (01223344886 ext. 088, moamen.meki@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Our primary outcome of this study will be: Duration of Analgesia. (time frame: till 24 hour postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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