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
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
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
NCT ID
NCT03643757
First Posted
August 16, 2018
Last Updated
August 21, 2018
Sponsor
Yedikule Training and Research Hospital
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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