- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290595
Comparative Analysis 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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Dr Muhammad Shahid, FCPS
- Phone Number: 00923336173056
- Email: shahidnishtar@gmail.com
Study Contact Backup
- Name: Dr Maryam Maqsood, MBBS
- Phone Number: 00923347036271
- Email: maryammaqsood448@gmail.com
Study Locations
-
-
Punjab Province
-
Sāhīwāl, Punjab Province, Pakistan, 57000
- Recruiting
- Sahiwal Medical College, Sahiwal
-
Contact:
- Dr Rao Riaz ul Haq, FCPS
- Phone Number: 0092404502470
- Email: slmcswl@gmail.com
-
Principal Investigator:
- Dr Maryam Maqsood, MBBS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Patients scheduled for upper limb surgery below mid-humerus level
- Patients aged 18 to 70 years
- Patients with ASA class I, II and III
- Male and non-pregnant females Exclusion Criteria
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Group A
0.5%Ropivacaine + 1mcg/kg Dexmedetomidine
|
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
Other Names:
|
|
Other: Group B
0.5%Ropivacaine + 8mg Dexamethasone
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post Operative Analgesia
Time Frame: from performance of block upto 5 minutes
|
Onset of Motor Block
|
from performance of block upto 5 minutes
|
|
Post Operative Analgesia
Time Frame: from performance of Block upto 5 minutes
|
Onset of Sensory Block
|
from performance of Block upto 5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Adeel Riaz, MD, Sahiwal medical college sahiwal
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Arrhythmias, Cardiac
- Pathological Conditions, Signs and Symptoms
- Hypotension
- Bradycardia
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Azoles
- Polycyclic Compounds
- Imidazoles
- Anilides
- Amides
- Aniline Compounds
- Amines
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Pregnadienetriols
- Ropivacaine
- Dexamethasone
- Dexmedetomidine
Other Study ID Numbers
- 173-IRB/SLMC/SWL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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