NCT07279727

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
11mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Jan 2026Apr 2027

First Submitted

Initial submission to the registry

November 27, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

December 12, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

November 27, 2025

Last Update Submit

December 10, 2025

Conditions

Regional Anaesthesia

Keywords

NalbuphineDexmedetomidineDuration of analgesiaBupivacaineInfraclavicular block

Outcome Measures

Primary Outcomes (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.

    till 24 hour postoperative

Secondary Outcomes (5)

  • Onset time of sensory and motor block

    till 20 minute after the block

  • Duration of sensory and motor block

    20 minute after the block

  • Time to first rescue analgesic request

    till 24 hour postoperative

  • Heart rate (HR)

    till 24 hour postoperative

  • Mean arterial blood pressure (MAP)

    24 hour postoperative

Study Arms (2)

nalbuphine group

ACTIVE COMPARATOR

• Patients in group N (Nalbuphine group) will receive 29 mL of 0.5% bupivacaine + 1 mL (containing 10 mg nalbuphine)

Drug: Nalbuphine

Dexmedetomidine group

ACTIVE COMPARATOR

• Patients in group D (Dexmedetomidine group) will receive 29 mL of 0.5% bupivacaine + 1mL (containing 75 µg dexmedetomidine

Drug: Dexmedetomidine

Interventions

NalbuphineDRUG

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

nalbuphine group
DexmedetomidineDRUG

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

Also known as: precedex
Dexmedetomidine group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Assiut University, Assiut,

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Interventions

NalbuphineDexmedetomidine

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Momen mostafa meki, Dr

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Momen mostafa meki, dr

CONTACT

01223344886moamen.meki@med.aun.edu.eg

Hossam El-din Gamal Fakhry, Dr.

CONTACT

01026269773hossam.hg@aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia and icu

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 12, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

December 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Locations

EG(1)