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

NCT03081728 | Completed DMC

• 1 other identifier: NK/3017/MD/051
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• incidence of hemidiaphragmatic paralysis

  incidence of hemidiaphragmatic paralysis by M mode USG to be seen

  24 hours

Secondary Outcomes (1)

• postoperative pain

  24 hours

Study Arms (2)

block

EXPERIMENTAL

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

control

EXPERIMENTAL

IV analgesia only with diclofenac and paracetamol

Drug: IV diclofenac and IV paracetamol

Interventions

Interscalene Block with Ropivacaine Hcl 0.2% Inj Vil 10Ml DEVICE

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

Also known as: ROPIN

block

IV diclofenac and IV paracetamol DRUG

iv diclofenac 75 mg TDS iv paracetamol 1gm TDS

Also known as: vovran and perfalgan

control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

Location

Related Publications (3)

• 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.

  PMID: 21751435 BACKGROUND

• 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.

  PMID: 19920426 BACKGROUND

• 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.

  PMID: 19608563 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Diclofenac; Acetaminophen

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior resident, Department of Anaesthesia and Intensive Care, MD

Model Details: Two groups: 1- block + GA 2- GA with multimodal analgesia

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 16, 2017
• Study Start: April 1, 2017
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)