drugset / Trial / NCT04385966

Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block

NCT04385966

RandomizedParallel-groupTriple-blindDiagnostic

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.

Timeline

Start
2020-02-11
Primary completion
2021-10-20
Completion
2021-10-20

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Levobupivacaine Other / unclassified 10 ml Other
Subject Levobupivacaine Other / unclassified 20 ml Other

Indications