Incidence Of Hemidiaphragmatic Paralysis After Usg Guided Low Dose Interscalene Brachial Plexus Block

Incidence Of Hemidiaphragmatic Paralysis With Patient Controlled Infusion Of Low Volume Of Ropivacaine After Usg Guided Low Dose Interscalene Brachial Plexus Block

to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug followed by 24 hours continous infusion of drug

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Device: Interscalene Block with Ropivacaine Hcl 0.2% Inj Vil 10Ml; Drug: IV diclofenac and IV paracetamol

Detailed Description

to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug followed by 24 hours continous infusion of drug. To see hemidiaphragmatic paralysis by seeing diaphragmatic excursion on M mode Usg subcostal approach, to see post operative pain, patient satisfaction score, complications if any

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 18-65 years and belonging to ASA grade I, II, III, undergoing either, shoulder surgery, (rotator cuff repair, acromioplasty, hemiarthroplasty, and total shoulder replacement) or surgery for proximal humerus fracture will be recruited for the study.

Exclusion Criteria:

• a) Patient refusal for interscalene block b) Severe respiratory disease (FEV1/FVC <0.7 and FEV1 < 80% of predicted) c) Allergy to amide local anaesthetic drugs d) Chronic opioid therapy e) Patients who cannot understand how to operate PCA and VAS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: block; will be given block and continuous infusion with bolus 10ml of 0.5% ropivacaine followed by infusion @ 2ml/hr of 0.2% ropivacaine	Device: Interscalene Block with Ropivacaine Hcl 0.2% Inj Vil 10Ml; bolus 10ml of 0.5% ropivacaine followed by infusion @ 2ml/hr of 0.2% ropivacaine; Other Names: ROPIN
Experimental: control; IV analgesia only with diclofenac and paracetamol	Drug: IV diclofenac and IV paracetamol; iv diclofenac 75 mg TDS iv paracetamol 1gm TDS; Other Names: vovran and perfalgan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hemidiaphragmatic paralysis	incidence of hemidiaphragmatic paralysis by M mode USG to be seen	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	VAS score will taken	24 hours

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Publications and helpful links

General Publications

• Sinha SK, Abrams JH, Barnett JT, Muller JG, Lahiri B, Bernstein BA, Weller RS. Decreasing the local anesthetic volume from 20 to 10 mL for ultrasound-guided interscalene block at the cricoid level does not reduce the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):17-20. doi: 10.1097/aap.0b013e3182030648.
• Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.
• Fredrickson MJ, Price DJ. Analgesic effectiveness of ropivacaine 0.2% vs 0.4% via an ultrasound-guided C5-6 root/superior trunk perineural ambulatory catheter. Br J Anaesth. 2009 Sep;103(3):434-9. doi: 10.1093/bja/aep195. Epub 2009 Jul 16.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): November 16, 2017
• Study Completion (Actual): November 16, 2017

Study Registration Dates

• First Submitted: March 12, 2017
• First Submitted That Met QC Criteria: March 12, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 29, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Respiratory Insufficiency; Paralysis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Anesthetics, Local; Acetaminophen; Ropivacaine; Diclofenac
• Other Study ID Numbers: NK/3017/MD/051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No