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

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081728
• Other study ID #: NK/3017/MD/051
• Status: Completed
• Phase: N/A
• First received: March 12, 2017
• Last updated: December 29, 2017
• Start date: April 1, 2017
• Est. completion date: November 16, 2017

Study information

• Verified date: December 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 16, 2017
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

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

Drug:
• IV diclofenac and IV paracetamol
iv diclofenac 75 mg TDS iv paracetamol 1gm TDS

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of hemidiaphragmatic paralysis	incidence of hemidiaphragmatic paralysis by M mode USG to be seen	24 hours
Secondary	postoperative pain	VAS score will taken	24 hours