is There an Alternative to Ultrasound Guided Interscalene Block?

Regional Anesthesia Clinical Trial

Official title:

the Association of Ultrasound Guided Suprascapular and Supraclavicular Nerve Block Provides Adequate Analgesia in Comparison With Ultrasound Guided Interscalene Block

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02397330
• Other study ID #: TunisianMH1
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2015
• Last updated: March 23, 2015
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Tunisian Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

Interscalene brachial plexus block is the gold standard for perioperative pain management in shoulder surgery. However, this technique would have side effects and potential serious complications. The aim of this study is to compare between the combination of ultrasound guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene brachial plexus block for post operative analgesia after shoulder instability surgery with latarjet procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA physical status I-III

• 18-75 years of age, inclusive

• shoulder surgery (LATARJET technique)

Exclusion Criteria:

• contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)

• existing neurological deficit

• pregnancy

• history of neck surgery or radiotherapy

• severe respiratory disease

• inability to understand the informed consent and demands of the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Interscalene Block
• Regional Anesthesia
• Shoulder Surgery

Intervention

Drug:
• bupivacaine

Device:
• ultrasound
ultrasound guided nerve blocks

Drug:
• morphine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tunisian Military Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogic Scale	quality of postoperative analgesia	until 48 hours postoperative	No
Secondary	time to perform the blocks		up to 5 minutes	No
Secondary	patient satisfaction	scale from 0 (not satisfied at all) to 100 (full satisfaction)	48 hours post performing nerves blocks	No
Secondary	occurrence of complications		48 hours post performing nerves blocks	No
Secondary	total dose of morphine consumption in mg		during 48 hours post operative	No