- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07269678
Comparative Study of Two Infraclavicular Block Approaches in Forearm Surgery
A Comparative Study of Retroclavicular and Classical Coracoid Infraclavicular Brachial Plexus Blocks Using 0.5% Ropivacaine in Patients Undergoing Forearm Surgery.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Sargodha, Punjab Province, Pakistan, 40100
- Dr Faisal Masood teaching Hospital Sargodha
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients from 18-60 years.
- Male Patients
- Elective forearm surgery
- BMI ≤30kg/m2
- American Society of Anesthesiologist (ASA) Physical Status ≤III
Exclusion Criteria:
- History of known allergy or hypersensitivity against study drug.
- Previous surgery on the same limb
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Retroclavicular approch
Use of 25 ml 0.5% Ropivacaine via Retroclavicular Approach
|
The retro clavicular approach to the Infraclavicular brachial plexus block will be performed by placing probe parasagittally just medial to the coracoid process and caudal from the clavicle.
The needle insertion point was located in the supraclavicular fossa, just medial to the shoulder at a point sufficiently posterior to the clavicle and medial to the trapezius muscle insertion point on the clavicle.
The needle will be inserted immediately above the clavicle in the space between the coracoid process and the clavicle and advanced from cephalad to caudal.
|
|
Other: Classic coracoid approch
Classic Coracoid Infraclavicular Block with 25 ml 0.5% Ropivacaine
|
The coracoid approach to the Infraclavicular brachial plexus block will be performed by placing the ultrasound probe parasagittally just medial to the coracoid process and caudal from the clavicle.
The needle will be inserted cephalad to the ultrasound probe using an in-plane technique and advanced in a caudal direction toward the posterior aspect of the axillary artery, in the vicinity of the posterior cord of the brachial plexus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1 onset of motor block.
Time Frame: Intraoperatively
|
Onset of motor block assess using modified bromage scale Score Grade of motor blockade(Modified bromage scale) 0 Normal muscle function with full range of movement of elbow, wrist and fingers . 1 Decreased muscle power so that patient can move fingers and /or wrist only 2. Complete loss of muscle function with no movement in fingers/wrist |
Intraoperatively
|
|
Onset of sensory Block
Time Frame: Intraoperatively l
|
Onset of sensory block assess using pin prick method Grade of sensory blockade Score
|
Intraoperatively l
|
|
Block adequate for surgery
Time Frame: Intraoperatively
|
Block adequate for surgery when there is no need for local infiltration and general anesthesia
|
Intraoperatively
|
|
Needle Shadow and shaft visibility using 5 point likert scale.
Time Frame: Intraoperatively
|
NEEDLE SHADOW VISIBILITY 5-POINT LIKERT SCALE SCORE Needle tip visibility
5-POINT LIKERT SCALE SCORE Needle Shaft visibility
|
Intraoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rescue anesthesia requirement
Time Frame: Intraoperatively after regional block
|
Rescue anesthesia given when block is not adequate for surgery such as local infiltration and general anesthesia
|
Intraoperatively after regional block
|
|
Complication
Time Frame: Intraoperatively
|
Vascular puncture and pneumothorax
|
Intraoperatively
|
|
Procedure Time
Time Frame: Intraoperatively
|
Time from insertion of needle to removal of needle
|
Intraoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- SMC-ANS-2025-001
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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