Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block

• Status: Recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

Summary

Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA).

This is a comparative, prospective, Unicenter, double-blind, two-arm, randomized and controlled clinical trial. 48 patients will be included.

This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto de Investigación Sanitaria Aragón
• Collaborators: Hospital Miguel Servet; Hospital Universitario Miguel Servet
• Treatments: Levobupivacaine

Criteria

Inclusion Criteria:

• Patients aged 18 to 80 years.

• ASA I-III.

• Scheduled for shoulder arthroscopic shoulder surgery and interscalene brachial plexus block.

Exclusion Criteria:

• Age <18 and >80 years.

• Pregnancy.

• Exclusión to perform IBPB or spirometry.

• Allergy to amide group local anaesthetics, opioids or nonsteroidal anti-inflammatory drugs.

• Background of Pulmonary diseases (chronic obstructive pulmonary disease (COPD) and moderate, severe or not well-controlled asthma), diaphragmatic paralysis or neurological disease with diaphragmatic dysfunction, brachial plexus neuropathy or chronic opioid consumption (more than 3-months consumption or more than oral Morphine 1 mg 1-month).

• Coagulation disorders (INR>3, TTPA > 35 y AP <50%).