Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block
Condition: Diaphragmatic Paralysis; Brachial Plexus Block
MeSH terms: Respiratory Paralysis; Paralysis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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).

      The primary study objective is to determine the HDPA diagnosed by using diaphragmatic
      thickness index in Ultrasound (US) after Low Volume (10 mL) versus Standard Volume (20 mL) of
      Levobupivacaine 0,25% for IBPB. Secondary end-points are 1) HDPA diagnosed by using FVC and
      FEV1 in spirometry, 2) HDPA diagnosed by using diaphragmatic excursion in US, 3)
      postoperative pain regarding time to first analgesic consumption and 24-hour cumulative total
      consumption of Patient-controlled analgesia (PCA) pump of Morphine IV and (4) postoperative
      harms between two trial-arms.

      This study is a comparative, prospective, Unicenter, double-blind and two-arm RCT. 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.
    

Intervention name(s): Interscalene brachial plexus block; Levobupivacaine Hydrochloride 2.5 MG/ML
Intervention type(s): Procedure; Drug
Intervention description(s): Interscalene brachial plexus block is a locorregional anaesthesia technique which is indicated in shoulder and upper arm surgery. The goal of this block is to place the needle in the tissue space between the anterior and middle scalene muscles and inject local anesthetic until the spread around the brachial plexus is documented by ultrasound.; Levobupivacaine Hydrochloride 2.5 MG/ML is an anesthestic product intended for epidural, intradural and perineural administration. Levobupivacaine is chemically described as (S)-l-butyl-2-piperidylformo-2',6'-xylidide hydrochloride. It is a white crystalline powder with a molecular formula of C18H28N2O. HCl, with a molecular weight 324.9.
FDA approval: NDA-20997 (1999).
Other intervention name(s): MeSH Unique ID: D065527; CIE-10 code 3E0T3CZ; Interscalene block; Chirocaine® 2.5 MG/ML
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The REDOLEV study is a randomized, comparative, prospective, unicenter, double-blind, two-arm and controlled Clinical trial (RCT).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Diaphragmatic Paralysis; Interscalene Brachial Plexus Block; Ultrasound; Postoperative pain; Arthroscopic shoulder surgery.