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Comparison of Diaphragmatic Weakness In Extrafascial and Inrtafascial Interscalene Brachial Plexus Block

Impact Of Interscalene Brachial Plexus Block Causing Hemidiphragmatic Paresis in Extrafascial And Intrafascial Injections : A Prospective Double Blind Randomized Clinical Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087855
Enrollment
70
Registered
2025-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Extrafascial interscalene Block: A 22 G Needle is inserted under ultrasound guidance connected to a peripheral nerve stimulator along the brachial plexus sheath identified as hyperechoi

Sponsors

Government Medical college,Baroda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient posted for mid shaft and distal humerus surgeries Age Group in the range of 18 to 65 years of either sex. Weight in the range of 45 to 70 kilogram. ASA grade 1 and 2 Duration of Surgery Less than 3 hours. Patient able to give written and informed consent.

Exclusion criteria

Exclusion criteria: Patient not willing for procedure. Existing neurological deficit in the upper limb, history of neck surgery or radiotherapy severe pulmonary disease, chest deformity, Contraindications to peripheral nerve block(allergy to local anaesthetics, coagulopathy, infection in the area), and pregnancy. Patients with significant history of drug or alcohol abuse, psychiatric illness.

Design outcomes

Primary

MeasureTime frame
Comparing the Hemidiaphragmatic paresis by measuring the percentage of reduction in diaphragmatic excursion with the help of M-mode ultrasonography.Timepoint: Before and 30 minutes after the interscalene block in all patients.

Secondary

MeasureTime frame
To be observed for difference in Peak expiratory flow rate FEV1 ( Forced expiratory volume in 1 sec) Measured by digital spirometer-peak flow meter device before and 30 minutes after giving block. To be observed for change in Respiratory rate and SpO2 perioperatively by pulse oximeter. Sensory block will be assessed by observing time to achieve complete sensory effect and its duration. Motor block will be assessed by observing time to achieve complete motor effect and its duration. To be observed for block efficacy (success rate) in terms of additional anaesthsia requirement during surgery (such as IV Fentanyl 1-2mcg/kg , local infiltration, Inj. Ketofol 1:1 ) . Perioperatively haemodynamic parameters will be observed ( pulse rate, mean arterial pressure). Complications if any will be observed perioperatively for 24 hrs.Timepoint: After standard instructions, the patient in a sitting upright position will be asked to inspire maximally and blow into the device as fast and strong as possible. The test will be repeated three times and the best value will be recorded with a bedside peakflow meter before procedure and 30 minutes after procedure.

Countries

India

Contacts

Public ContactDr Neha Shah

Government medical college, Baroda

nehakinitshah@gmail.com8610038510

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026