- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418086
Supraclavicular Block vs Bier's Block for Forearm Trauma Surgery
Comparative Study of Supraclavicular Block and Bier's Block in Forearm Surgery in Trauma Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
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Sargodha, Punjab Province, Pakistan, 40100
- DHQ Sargodha
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 60 years
- ASA physical status I-III
- Patients scheduled for elective or emergency forearm surgery
- Presence of forearm fracture or upper limb trauma requiring regional anesthesia
- Ability to provide informed consent
Exclusion Criteria:
- Patient refusal or inability to give informed consent
- Known allergy to local anesthetic agents
- Coagulopathy or bleeding disorders
- Infection at the block site
- Pre-existing neurological deficits in the affected limb
- Severe cardiac, hepatic, or renal disease
- History of seizure disorders
- Pregnancy
- ASA physical status IV or higher
- Inability to cooperate with block assessment
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 |
|---|---|
|
Experimental: Bier's Block (IVRA)
Participants assigned to this arm received a Bier's block (Intravenous Regional Anesthesia).
After IV access was established distally in the operative limb, the limb was exsanguinated using an Esmarch bandage and a double pneumatic tourniquet was applied.
The proximal cuff was inflated 50-100 mmHg above systolic pressure, followed by IV administration of 30 mL of 0.5% lidocaine.
The distal cuff was inflated after 20-30 minutes or upon tourniquet discomfort.
This technique provided regional anesthesia for forearm surgery.
|
Participants received an intravenous regional anesthesia (Bier's block).
After placement of an IV line in the distal operative limb, the limb was exsanguinated with an Esmarch bandage and a double-cuff tourniquet was applied.
The proximal cuff was inflated 50-100 mmHg above systolic pressure, followed by injection of 30 mL of 0.5% lidocaine through the IV.
The distal cuff was inflated after 20-30 minutes or if tourniquet discomfort occurred.
This technique produced regional anesthesia for forearm surgery.
|
|
Experimental: Supraclavicular Block
Participants received an ultrasound-guided supraclavicular brachial plexus block.
After premedication with midazolam (1 mg) and nalbuphine (0.1 mg/kg), a 30 mL local anesthetic dose was injected using a two-point needle technique under real-time ultrasound visualization.
A single tourniquet was applied at 100 mmHg above systolic pressure after block establishment.
This technique provided anesthesia for forearm trauma surgery.
|
Participants received an ultrasound-guided supraclavicular brachial plexus block.
Premedication included midazolam (1 mg IV) and nalbuphine (0.1 mg/kg IV).
A total of 30 mL local anesthetic was injected using a two-point needle technique under real-time ultrasound visualization.
After block establishment, a single tourniquet was applied at 100 mmHg above systolic pressure for the surgical procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1)onset of sensory block 2)degree of motor blockade
Time Frame: 6 months
|
ONSET OF SENSORY BLOCK It is the period of time between the local anesthesia injection and the loss of pinprick sensation. 0=feeling sharp pinprick (no block)
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3)duration of analgesia
Time Frame: 6 months
|
DURATION OF ANALGESIA It was calculated from the time of onset of loss of pinprick for the first time during post-operative period (next 24 hrs.).
The Visual Analogue Scale was used to determine pain scores.
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
4)patient comfort
Time Frame: 6 months
|
The modified Gloucester scale will be used to assess it.
|
6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Dodds SD, et al. The utility of CT scans for distal radius fractures. J Hand Surg. 2008;33:954-957.
- Small J, Brennwald J. Median nerve palsy associated with distal radius fracture. J Hand Surg. 1994;19:185-186.
- Pidgeon TS, et al. The operative treatment of distal radial fractures: a review of evidence. J Hand Surg. 2010;35:654-660.
- Houshian S, Torfing T, Borris LC. The epidemiology of elbow fractures in adults. J Shoulder Elbow Surg. 2001;10:43-47.
- Lamblet Z, Derossis AM, Isler MH, Sanders DW. Isolated ulnar shaft fractures can be treated with closed reduction and cast immobilization: a retrospective review. J Bone Joint Surg Am. 2004;86-A:1901-1905.
Helpful Links
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SMC-ANS-2025-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Your study is a single-center anesthesia comparison trial.
There is no requirement to share individual participant data (IPD).
Unless you have a formal data-sharing mechanism (repository, request process, timelines), selecting Yes will create extra mandatory fields.
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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