Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block

Shoulder Arthropathy Associated With Other Conditions Clinical Trial

Official title:

Shoulder Analgesia Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block. A Randomized Controlled Double Blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331237
• Other study ID #: REC007
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2017
• Last updated: October 31, 2017
• Start date: October 9, 2017
• Est. completion date: April 2018

Study information

• Verified date: October 2017
• Source: Healthpoint Hospital
• Contact: Sabah Zahooruddin
• Phone: 009712 4929000
• Email: s.zahooruddin[@]helathpoint.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For shoulder analgesia, both ISO block and low volume scalene (LVS) block (using 5 ml of local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis (HDP).

The aim of this study was to compare the incidence of HDP and the analgesic efficacy of the LVS block versus ISO block.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who were scheduled for arthroscopic shoulder surgery

Exclusion Criteria:

• aged <18y

• BMI >35,

• ASA greater >III,

• an infection at the injection site

• has a contraindication for laryngeal mask or the medications used in this study.

Related Conditions & MeSH terms

• Joint Diseases
• Shoulder Arthropathy Associated With Other Conditions

Intervention

Procedure:
• scalene block
scalene block using 5ml of ropivacaine
• ISO block
ISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture

Locations

Country	Name	City	State
United Arab Emirates	Healthpoint Hospital	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint Hospital

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemi-diaphragmatic pariesis	diaphragmatic caudal displacement will be measured (in cm) with real time ultrasound before the block performance and after the procedure	2-4 hours
Secondary	analgesic efficacy (block success)	successful block = pain free (VAS 0) in recovery unit. VAS will be used to evaluate the pain (0 = pain free, 10= most sever pain)	2-4 hours
Secondary	patient satisfaction	if the patient is satisfied with the analgesia technique or not	24 hours
Secondary	duration of analgesia	duration between the block performance and the first requesting of pain killer (morphine)	24 hours
Secondary	total morphine dose	the total morphine consumption within 24 hrs after the block performance	24 hours