NCT07290595

Brief Summary

To compare the efficacy of dexmedetomidine and dexamethasone as an adjuvant to 0.5%ropivacaine on onset of ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries. Ropivacaine hydrochloride, a long acting local anesthetic, is commonly used for supraclavicular block owing to its favorable safety profile especially in terms of minimal cardiotoxicity and less motor block. Dexmedetomidine, a highly selective alpha-2 adrenergic agonist, enhances the quality of supraclavicular block by providing sedation and analgesia while potentially prolonging the duration of block through hyperpolarization of nerve fibers. While, Dexamethasone, a synthetic corticosteroid with potent anti-inflammatory and immunosuppressive properties, prolongs duration of analgesia by reducing perineural inflammation and inhibiting nociceptive signal transmission. Supraclavicular brachial plexus block offers dense anesthesia for surgical procedures at or distal to the elbow with relatively high success rate, once described as "spinal of the arm". Moreover, supraclavicular brachial plexus block is an excellent alternative to general anesthesia in upper limb surgeries.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2026

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 16, 2025

Last Update Submit

December 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Post Operative Analgesia

    Onset of Sensory Block

    from performance of Block upto 5 minutes

  • Post Operative Analgesia

    Onset of Motor Block

    from performance of block upto 5 minutes

Study Arms (2)

Group A

OTHER

0.5%Ropivacaine + 1mcg/kg Dexmedetomidine

Drug: Ropivacaine + Dexmedetomidine

Group B

OTHER

0.5%Ropivacaine + 8mg Dexamethasone

Drug: Ropivacaine + dexamethasone

Interventions

Supraclavicular brachial plexus block will be performed under aseptic measures with the patient lying supine with head turned 30 degrees toward the contralateral side. A linear 7-13 MHz ultrasonography probe (ACUSON P500, digital color doppler ultrasound Siemens Germany) will be placed in supraclavicular fossa and slightly angled towards the thorax. The brachial plexus appears as multiple hypoechoic disks just superficial and lateral to the subclavian artery. After identification of brachial plexus, the proposed puncture site will be infiltrated with 1ml of 2% lignocaine. Then, 25-gauge spinal needle will be inserted using in plane technique, from lateral to medial direction until the tip is visualized near the brachial plexus. After careful aspiration for blood, 28ml of 0.5%Ropivacaine + 1mcg/kg Dexmedetomidine (diluted in 2ml normal saline) will be injected in 5ml increments to obtain uniform spread around brachial plexus

Also known as: Supravlavicular Brachial Plexus Block with Ropivacaine and Dexmedetomidine
Group A

Supraclavicular brachial plexus block will be performed under aseptic measures with the patient lying supine with head turned 30 degrees toward the contralateral side. A linear 7-13 MHz ultrasonography probe (ACUSON P500, digital color doppler ultrasound Siemens Germany) will be placed in supraclavicular fossa and slightly angled towards the thorax. The brachial plexus appears as multiple hypoechoic disks just superficial and lateral to the subclavian artery. After identification of brachial plexus, the proposed puncture site will be infiltrated with 1ml of 2% lignocaine. Then, 25-gauge spinal needle will be inserted using in plane technique, from lateral to medial direction until the tip is visualized near the brachial plexus. After careful aspiration for blood,28ml of 0.5%Ropivacaine + 8mg Dexamethasone (2ml)will be injected in 5ml increments to obtain uniform spread around brachial plexus

Also known as: Supraclavicular Brachial Plexus Block with Ropivacaine and Dexamethasone
Group B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for upper limb surgery below mid-humerus level
  • Patients aged 18 to 70 years
  • Patients with ASA class I, II and III

You may not qualify if:

  • Patients refusal
  • Patients with pre-existing peripheral neuropathy of the upper limb
  • Patients with the Infection at block site
  • Patients with history of ischemic heart disease
  • Patients with bleeding disorder or deranged coagulation profile
  • Patients with known history of allergy to local anaesthetic or any other drugs used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahiwal Medical College, Sahiwal

Sāhīwāl, Punjab Province, 57000, Pakistan

RECRUITING

MeSH Terms

Conditions

BradycardiaHypotension

Interventions

RopivacaineDexmedetomidineDexamethasone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Adeel Riaz, MD

    Sahiwal medical college sahiwal

    STUDY DIRECTOR

Central Study Contacts

Dr Maryam Maqsood, MBBS

CONTACT

Dr Muhammad Shahid, FCPS

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A will receive 28ml of 0.5%Ropivacaine + 1mcg/kg Dexmedetomidine (diluted in 2ml normal saline) and Group B will receive 28ml of 0.5%Ropivacaine + 8mg Dexamethasone (2ml).
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Graduate Resident

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 18, 2025

Study Start

January 13, 2025

Primary Completion

February 12, 2026

Study Completion

March 12, 2026

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data will be available on request after completion of study i.e. March 2026

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
March 2026
Access Criteria
On Demand

Locations