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

NCT ID: NCT03081728

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-11-16

Brief Summary

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

Detailed Description

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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

Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Two groups: 1- block + GA 2- GA with multimodal analgesia
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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block

will be given block and continuous infusion with bolus 10ml of 0.5% ropivacaine followed by infusion @ 2ml/hr of 0.2% ropivacaine

Group Type EXPERIMENTAL

Interscalene Block with Ropivacaine Hcl 0.2% Inj Vil 10Ml

Intervention Type DEVICE

bolus 10ml of 0.5% ropivacaine followed by infusion @ 2ml/hr of 0.2% ropivacaine

control

IV analgesia only with diclofenac and paracetamol

Group Type EXPERIMENTAL

IV diclofenac and IV paracetamol

Intervention Type DRUG

iv diclofenac 75 mg TDS iv paracetamol 1gm TDS

Interventions

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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

Intervention Type DEVICE

IV diclofenac and IV paracetamol

iv diclofenac 75 mg TDS iv paracetamol 1gm TDS

Intervention Type DRUG

Other Intervention Names

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ROPIN vovran and perfalgan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Dr. Pankaj

Junior resident, Department of Anaesthesia and Intensive Care, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PGIMER

Chandigarh, , India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 21751435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19920426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19608563 (View on PubMed)

Other Identifiers

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NK/3017/MD/051

Identifier Type: -

Identifier Source: org_study_id

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