Trial intelligence / Profile preview

Combined GA and Bilateral TPVB in OPCAB

NCT02727712Phase 4

Key facts

Status
Unknown
Start
Apr 2016
Primary completion
Sep 2016
Countries
1
Sponsor
Xiangya Hospital, Central South University
Modality
Targeted Liposomes, Stealth (PEGylated) Liposomes, Conventional Liposomes
Conditions
pain
01

Overview

Phase 4, randomised, double-blind trial of ropivacaine hydrochloride liposomal suspension injection in pain (3 arms), sponsored by Xiangya Hospital, Central South University. Primary endpoints: Fasting blood glucose at 4 days, Blood Lactic Acid at 4 days and 6 more. Status: unknown.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • TPVB T2/3+T5/6+GA

    Bilateral TPVB (T2/3+T5/6) with ropivacaine + General Anesthesia

  • TPVB T3/4+GA

    Bilateral TPVB (T3/4) with ropivacaine + General Anesthesia

  • GA

    Conventional General Anesthesia without block

03

Endpoints

Primary

  • Fasting blood glucose

  • Blood Lactic Acid

  • Creatine kinase isoenzymes

  • Myoglobin

  • Troponin I

Secondary

  • Perioperative major adverse events

  • Perioperative use of vasoactive drug species

  • Vasoactive drugs Support Hours

  • Postoperative tracheal tube time

  • Duration of mechanical ventilation after surgery

  • Length of ICU stay

  • The total length of hospital stay

  • Visual analog pain score

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