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Epidural Analgesia and Postoperative Respiratory Functions (EPAPRES) (EPAPRES)

Primary Purpose

Respiration Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thoracic epidural analgesia
Bupivacaine
Sponsored by
Yedikule Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiration Disorders focused on measuring Blood gas analysis, Epidural analgesia, Lung cancer, Respiratory function tests, Thoracotomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists -ASA- Class I to III)
  • Scheduled for an elective thoracic surgical procedure with posterolateral thoracotomy

Exclusion Criteria:

  • Individuals beyond defined age limits
  • Having psychiatric problems
  • Having an auditory deficit
  • Active drug abuse
  • Severe cardiovascular system disorders
  • Severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume
  • Refusing to give consent
  • Contraindication to insertion of an epidural catheter.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Thoracic Epidural Analgesia

    Intravenous analgesia

    Arm Description

    Population to whom thoracic epidural analgesia with bupivacaine as a component of multimodal analgesia was administered.

    Population to whom combined intravenous analgesia was administered.

    Outcomes

    Primary Outcome Measures

    Postoperative FEV1 and FVC alterations
    Comparison of preoperative and postoperative FEV1 (liters, %) and FVC.(liters, %)

    Secondary Outcome Measures

    Postoperative pH alteration
    pH value at 1st and 24th postoperative hours were compared
    Postoperative pO2 alteration
    pO2 (mmHg) value at 1st and 24th postoperative hours were compared
    Postoperative pCO2 alteration
    pCO2 (mmHg) value at 1st and 24th postoperative hours were compared
    Postoperative HCO3 concentration alteration
    Bicarbonate concentration (mEq/dL) at 1st and 24th postoperative hours were compared

    Full Information

    First Posted
    August 16, 2018
    Last Updated
    August 21, 2018
    Sponsor
    Yedikule Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03643757
    Brief Title
    Epidural Analgesia and Postoperative Respiratory Functions (EPAPRES)
    Acronym
    EPAPRES
    Official Title
    Comparison of Thoracic Epidural and Intravenous Analgesia From the Perspective of Recovery of Respiratory Function at Early Post-thoracotomy Period in Lung Cancer Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2015 (Actual)
    Primary Completion Date
    August 1, 2017 (Actual)
    Study Completion Date
    March 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yedikule Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients operated with posterolateral thoracotomy were enrolled. Post-operative analgesia was provided either by TEA with 0.1% bupivacaine or pethidine based intravenous analgesia (IVA) in our sample population. Perception of pain was quantified by Visual Analogue Scale (VAS) at rest and during coughing. Arterial blood samples were collected at 1st, 24th and 72nd hours of post-operative period. Pre-operative and post-operative 72nd-hour spirometric measurements were recorded
    Detailed Description
    lung cancer patients (between ages 18 to 75 and American Society of Anesthesiologists -ASA- Class I to III), undergoing an elective thoracic surgical procedure with posterolateral thoracotomy, were enrolled. The study was approved by the local ethical committee in Yedikule Chest Diseases and Thoracic Surgery Ed. and Research Hospital and therefore had been performed in accordance with global ethical standards. Written informed consent was received from all participants. Individuals beyond defined age limits, patients who have psychiatric problems, auditory deficit, drug abuse, severe cardiovascular system disorders or severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume were excluded. Patients refusing to give consent and to whom inserting an epidural catheter is contraindicated were not involved either. Surgical procedures were performed by the same team. In the operating room, if serratus anterior muscle could not be spared or chest wall resection was performed, these patients were also excluded even though they had met other qualifications. Finally, patients who could not be extubated before transfer were not involved. Regarding pre-operative evaluation, age, gender, weight, height, smoking status (package/years) and ASA score of patients were recorded. For assessing the impact of method of analgesia on target parameters, patients were allocated to TEA and intravenous analgesia (IVA) groups. Randomisation was performed by closed envelope method. 2.2 Features of anesthetic technique and intraoperative analgesia Before the initiation of procedure, in TEA group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of a 18 G Thuohy needle (Pajunk, Geisingen, Germany) while patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintanence was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours. Anesthesia was induced with midazolam (0.04 mg/kg), propofol (2 mg/kg) and fentanyl (1mcg/kg) in both groups and the neuromuscular blockage was provided with cisatracurium besilate (0,2 mg/kg). Then, insertion of a double-lumen tracheal tube was performed. After standard patient positioning, localization of the tube was checked with a fiberoptic bronchoscope. Pressure controlled ventilation was used (Primius, Drager, Luebeck, Germany) and invasive arterial pressure, electrocardiography, arterial blood gas analysis, end-tidal carbon dioxide concentration, central venous pressure and urine output were closely monitored in the operating room. Hypothermia was avoided with the help of a warming system and body temperature was kept over 36°C. In TEA group, absolute intraoperative analgesia was warranted with 0,5-2 MAC sevoflurane. In IVA group, remifentanyl infusion (0.1-0.2 mcg/kg/min) was additionally used for this purpose. If arterial pressure exceeds a value of 20% or more of baseline recordings, 1 mcg/kg fentanyl was administered. Every one hour, an additional dose (0.25 mg/kg) of cisatracurium besilate was administered to ensure complete myorelaxation. The intercostal blockage was applied by the surgical team to the entire population before closing the wound by injecting 4 ml of 0.25% bupivacaine to the region of incision and two intercostal regions above and below the incision site. Once closure was started, morphine sulphate (0,1 mg/kg), tramadol (100 mg), paracetamol (100 mg) and tenoxicam (20 mg) was given intravenously. Anterior 28 Ch and posterior 32 Ch drainage tubes were inserted to the patients to whom lobectomy or bilobectomy was performed. For pneumectomy, only posterior 32 Ch tube was placed. After reversal of neuromuscular blocking agents, patients with adequate spontaneous ventilation and verbal response were transferred to the critical care unit. Regarding to peri-operative data, procedure time, type of the operation (lobectomy or pneumectomy), duration of tube drainage and presence of operation related complications were recorded. Visual Analogue Score (VAS) was used to estimate the severity of pain. A score of 0 cm represented "no pain at all" and 10 cm did "intractable pain" so.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiration Disorders
    Keywords
    Blood gas analysis, Epidural analgesia, Lung cancer, Respiratory function tests, Thoracotomy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Thoracic Epidural Analgesia
    Arm Type
    Active Comparator
    Arm Description
    Population to whom thoracic epidural analgesia with bupivacaine as a component of multimodal analgesia was administered.
    Arm Title
    Intravenous analgesia
    Arm Type
    Active Comparator
    Arm Description
    Population to whom combined intravenous analgesia was administered.
    Intervention Type
    Procedure
    Intervention Name(s)
    Thoracic epidural analgesia
    Other Intervention Name(s)
    Posterolateral thorachotomy, Intercostal blockade
    Intervention Description
    Before the initiation of the procedure, in the intervention group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of an 18 G Thuohy needle (Pajunk, Geisingen, Germany) while the patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintenance was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Pethidine intravenous infusion
    Intervention Description
    In addition to multimodal analgesia protocol, epidural bupivacaine was administered in TEA arm and pain relief was achieved by intravenous pethidine infusion in IVA arm.
    Primary Outcome Measure Information:
    Title
    Postoperative FEV1 and FVC alterations
    Description
    Comparison of preoperative and postoperative FEV1 (liters, %) and FVC.(liters, %)
    Time Frame
    3 days
    Secondary Outcome Measure Information:
    Title
    Postoperative pH alteration
    Description
    pH value at 1st and 24th postoperative hours were compared
    Time Frame
    24 hours
    Title
    Postoperative pO2 alteration
    Description
    pO2 (mmHg) value at 1st and 24th postoperative hours were compared
    Time Frame
    24 hours
    Title
    Postoperative pCO2 alteration
    Description
    pCO2 (mmHg) value at 1st and 24th postoperative hours were compared
    Time Frame
    24 hours
    Title
    Postoperative HCO3 concentration alteration
    Description
    Bicarbonate concentration (mEq/dL) at 1st and 24th postoperative hours were compared
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists -ASA- Class I to III) Scheduled for an elective thoracic surgical procedure with posterolateral thoracotomy Exclusion Criteria: Individuals beyond defined age limits Having psychiatric problems Having an auditory deficit Active drug abuse Severe cardiovascular system disorders Severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume Refusing to give consent Contraindication to insertion of an epidural catheter.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Can be provided on request
    IPD Sharing Time Frame
    1 week
    IPD Sharing Access Criteria
    E-mail
    Citations:
    PubMed Identifier
    24745020
    Citation
    Erturk E, Aydogdu Kaya F, Kutanis D, Besir A, Akdogan A, Geze S, Tugcugil E. The effectiveness of preemptive thoracic epidural analgesia in thoracic surgery. Biomed Res Int. 2014;2014:673682. doi: 10.1155/2014/673682. Epub 2014 Mar 13.
    Results Reference
    result
    PubMed Identifier
    28742434
    Citation
    Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. Use of Regional Anesthesia Techniques: Analysis of Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):898-902. doi: 10.1089/lap.2017.0339. Epub 2017 Jul 25.
    Results Reference
    result
    PubMed Identifier
    22531384
    Citation
    Rawal N. Epidural technique for postoperative pain: gold standard no more? Reg Anesth Pain Med. 2012 May-Jun;37(3):310-7. doi: 10.1097/AAP.0b013e31825735c6.
    Results Reference
    result

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    Epidural Analgesia and Postoperative Respiratory Functions (EPAPRES)

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