is There an Alternative to Ultrasound Guided Interscalene Block?

• Sponsor: Tunisian Military Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02397330
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Days): 30

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Regional Anesthesia; Interscalene Block; Shoulder Surgery	Drug: bupivacaine; Device: ultrasound; Drug: morphine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: the Association of Ultrasound Guided Suprascapular and Supraclavicular Nerve Block Provides Adequate Analgesia in Comparison With Ultrasound Guided Interscalene Block
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: May 1, 2015
• Anticipated Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group BIS scheduled for ultrasound guided interscalene blockade with 30 ml of bupivacaine 0.25%	Drug: bupivacaine; Device: ultrasound; ultrasound guided nerve blocks; Drug: morphine
Experimental: group BS scheduled for selective blockade of the ultrasound guided suprascapular (15 ml bupivacaine 0.25%) and supraclavicular (15 ml bupivacaine 0.25%) nerves blocks	Drug: bupivacaine; Device: ultrasound; ultrasound guided nerve blocks; Drug: morphine

Outcome Measures

Primary Outcome Measures

1. Visual Analogic Scale [until 48 hours postoperative]

   quality of postoperative analgesia

Secondary Outcome Measures

1. time to perform the blocks [up to 5 minutes]

2. patient satisfaction [48 hours post performing nerves blocks]

   scale from 0 (not satisfied at all) to 100 (full satisfaction)

3. occurrence of complications [48 hours post performing nerves blocks]

4. total dose of morphine consumption in mg [during 48 hours post operative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tunisian Military Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr trabelsi walid, associate professor, MD, Tunisian Military Hospital
• ClinicalTrials.gov Identifier: NCT02397330
• Other Study ID Numbers: TunisianMH1
• First Posted: Mar 24, 2015
• Last Update Posted: Mar 24, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Morphine; Bupivacaine

Study Results

No Results Posted as of Mar 24, 2015