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Comparison of programmed intermittent epidural bolus injection and continuous epidural injection in controlling night pain and improving sleep quality after thoracotomy

Status Approved

First Submitted Date

2020/07/01
Registered Date

2020/07/03
Last Updated Date

2021/08/07

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005198
Unique Protocol ID	05-2020-115
Public/Brief Title	Comparison of programmed intermittent epidural bolus injection and continuous epidural injection in controlling night pain and improving sleep quality after thoracotomy
Scientific Title	Comparison of programmed intermittent epidural bolus injection and continuous epidural injection in controlling night pain and improving sleep quality after thoracotomy
Acronym	PIEB-TEB
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	PNUYHIRB 05-2020-115
Approval Date	2020-05-20
Institutional Review Board Name	Pusan National University Yangsan Hospital Institutional Review Board
Institutional Review Board Address	20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do
Institutional Review Board Telephone	055-360-3854
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Gyeong-Jo Byeon
Title	Dr.
Telephone	+82-55-360-2758
Affiliation	Pusan National University Yangsan Hospital
Address	Pusan National University Yangsan Hospital, Geumoro 20, Mulgeumeup, Yangsan, Gyeongnam, Republic of Korea
Contact Person for Public Queries
Name	Gyeong-Jo Byeon
Title	Dr.
Telephone	+82-55-360-2758
Affiliation	Pusan National University Yangsan Hospital
Address	Pusan National University Yangsan Hospital, Geumoro 20, Mulgeumeup, Yangsan, Gyeongnam, Republic of Korea
Contact Person for Updating Information
Name	Gyeong-Jo Byeon
Title	Dr.
Telephone	+82-55-360-2758
Affiliation	Pusan National University Yangsan Hospital
Address	Pusan National University Yangsan Hospital, Geumoro 20, Mulgeumeup, Yangsan, Gyeongnam, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2020-06-22 Actual
Target Number of Participant	76
Primary Completion Date	2020-12-15 , Actual
Study Completion Date	2020-12-18 , Actual
Name of Study	Pusan National University Yangsan Hospital
Recruitment Status	Completed
Date of First Enrollment	2020-06-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Pusan National University Yangsan Hospital
Organization Type	Medical Institute
Project ID	05-2020-115

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Pusan National University Yangsan Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Postoperative pain in patients undergoing thoracotomy for lung cancer or lung disease is known to be very severe. As a result, it is known that spontaneous breathing of patients is not easy immediately after surgery, which affects chronic pain as well as early recovery after surgery. In addition, when nighttime breakthrough pain occurs after surgery, the patient requires additional analgesia, and the quality of sleep is disturbed. Therefore, proper pain control after thoracotomy is important, and pain control using epidural nerve block is known as the most effective pain control method. In several recent studies on patient controlled epidural analgesia (PCEA), the programmed intermittent epidural bolus (PIEB) technique of the PCEA reduces motor blockage and shows better analgesic effect. This study compares intermittent epidural bolus injection and continuous epidural injection using the program of the PCEA device. This study aims to investigate the effects of night pain control after thoracotomy according to the administration method, and to examine the effects of these pain control effects on sleep improvement and postoperative recovery of patients.

Study Summary Information

Lay Summary

Postoperative pain in patients undergoing thoracotomy for lung cancer or lung disease is known to be very severe. As a result, it is known that spontaneous breathing of patients is not easy immediately after surgery, which affects chronic pain as well as early recovery after surgery. In addition, when nighttime breakthrough pain occurs after surgery, the patient requires additional analgesia, and the quality of sleep is disturbed. Therefore, proper pain control after thoracotomy is important, and pain control using epidural nerve block is known as the most effective pain control method.
  In several recent studies on patient controlled epidural analgesia (PCEA), the programmed intermittent epidural bolus (PIEB) technique of the PCEA reduces motor blockage and shows better analgesic effect. This study compares intermittent epidural bolus injection and continuous epidural injection using the program of the PCEA device. This study aims to investigate the effects of night pain control after thoracotomy according to the administration method, and to examine the effects of these pain control effects on sleep improvement and postoperative recovery of patients.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	In order to control postoperative pain, patient controlled analgesia using thoracic epidural block is applied to T6-T9 levels in both groups. The study subjects were divided into a control group (a group in which 0.2% levobupivacaine was continuously injected at a rate of 1.1 mL/h) and an experimental group (a group injecting 3 mL of 0.2% levobupivacaine intermittently at 3 hour intervals).
Number of Arms	2
Arm 1	Arm Label group A
	Target Number of Participant 38
	Arm Type Active comparator
	Arm Description a group in which 0.2% levobupivacaine was continuously injected at a rate of 1.1 mL/h
Arm 2	Arm Label group B
	Target Number of Participant 38
	Arm Type Experimental
	Arm Description a group injecting 3 mL of 0.2% levobupivacaine intermittently at 3 hour intervals

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C34.99)Malignant neoplasm of bronchus or lung, unspecified, unspecified side Patients scheduled for thoracotomy for lung cancer or other lung diseases
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description Patients who are scheduled for thoracotomy due to lung cancer or other lung disease, who are American Society of Anesthesiology physical status I-III and over 19 years old.
Exclusion Criteria	Patients with difficult coordination, patients with blood clotting deficiencies, those with neurological defects at the treatment site, patients with allergic reactions to levobupivacaine in previous surgery or procedures, pregnant women are excluded.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Postoperative pain score
Timepoint	When communication is possible voluntarily in post-anesthesia care unit, the night of the day of surgery, day 1 after surgery, day 2 after surgery
Secondary Outcome(s) 1
Outcome	If pain control is poor, the total amount of pain medication administered, the frequency of administration, and the time of administration.
Timepoint	2 days after surgery
Secondary Outcome(s) 2
Outcome	Subject's sleep quality
Timepoint	On the day of surgery, 1 day after surgery
Secondary Outcome(s) 3
Outcome	Patient satisfaction with pain control
Timepoint	2 days after surgery
Secondary Outcome(s) 4
Outcome	Pattern of use of portable electronic injection pump in subjects for 48 hours after surgery
Timepoint	2 days after surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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