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Postoperative analgesic effect of erector spinae plane block after thoracoscopic surgery

Status Approved

First Submitted Date

2017/04/11
Registered Date

2017/04/21
Last Updated Date

2017/04/18

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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	KCT0002316
Unique Protocol ID	AJIRB-MED-DRU-17-021
Public/Brief Title	Postoperative analgesic effect of erector spinae plane block after thoracoscopic surgery
Scientific Title	Postoperative analgesic effect of erector spinae plane block after thoracoscopic surgery
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	AJIRB-MED-DRU-17-021
Approval Date	2017-04-04
Institutional Review Board Name	Ajou University Hospital Institutuional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
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	Han Bum Joe
Title	Associate Professor
Telephone	+82-31-219-4916
Affiliation	Ajou University Hospital
Address	164, World Cup-ro, Yeongtong-gu, Suwon 443-380, Korea
Contact Person for Public Queries
Name	Han Bum Joe
Title	Associate Professor
Telephone	+82-31-219-4916
Affiliation	Ajou University Hospital
Address	164, World Cup-ro, Yeongtong-gu, Suwon 443-380, Korea
Contact Person for Updating Information
Name	Han Bum Joe
Title	Associate Professor
Telephone	+82-31-219-4916
Affiliation	Ajou University Hospital
Address	164, World Cup-ro, Yeongtong-gu, Suwon 443-380, 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	Recruiting
Date of First Enrollment	2017-04-06 Actual
Target Number of Participant	62
Primary Completion Date	2018-03-31 , Anticipated
Study Completion Date	2018-03-31 , Anticipated
Name of Study	Ajou University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2017-04-06 ,

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	Ajou University Hospital
Organization Type	Medical Institute
Project ID	AJIRB-MED-DRU-17-021

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Ajou University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Although video-assisted thoracoscopic surgery (VATS) is less invasive than conventional open thoracotomy, it is accompanied by moderate-to-severe pain during the ealry postoperative period. Systemic opioid or epidural block have been applied to reduce the pain after VATS. However, there are always risks of diverse complications from adverse reactions caused by systemic opioid use or epidural block. Various ultrasound-guided peripheral nerve blocks such as Pecs block and serratus plane block, which can reduce such risks, are currently being carried out in thoracic surgery. Recently, erector spinae plane block (ESPB), which can block ventral and dorsal rami of ipsilateral multi-level spinal nerves, was introduced, and this block may reduce the pain after VATS technically easily with low risk of complications. Until now, however, there is a lack of clinical evidence on the effectiveness of ESPB. In this study, the authors aim to investigate the analgesic effect of ESPB on early postoperativel pain after VATS.

Study Summary Information

Lay Summary

Although video-assisted thoracoscopic surgery (VATS) is less invasive than conventional open thoracotomy, it is accompanied by moderate-to-severe pain during the ealry postoperative period. Systemic opioid or epidural block have been applied to reduce the pain after VATS. However, there are always risks of diverse complications from adverse reactions caused by systemic opioid use or epidural block. Various ultrasound-guided peripheral nerve blocks such as Pecs block and serratus plane block, which can reduce such risks, are currently being carried out in thoracic surgery.  Recently, erector spinae plane block (ESPB), which can block ventral and dorsal rami of ipsilateral multi-level spinal nerves, was introduced, and this block may reduce the pain after VATS technically easily with low risk of complications. Until now, however, there is a lack of clinical evidence on the effectiveness of ESPB.  
In this study, the authors aim to investigate the analgesic effect of ESPB on early postoperativel pain after VATS.

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	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	Sixty two patients are randomly allocated to ESPB group who receive single-injection ESPB, and control group who does not receive any block. ESPB is performed by one anesthesiologist under ultrasound guidance after anesthesia induction before surgery.
Number of Arms	2
Arm 1	Arm Label Control group
	Target Number of Participant 31
	Arm Type Active comparator
	Arm Description Patients in control group do not receive any block.
Arm 2	Arm Label ESPB group
	Target Number of Participant 31
	Arm Type Experimental
	Arm Description ESPB is performed in lateral decubitus position for VATS after anesthesia induction. Ipsilateral T5 transverse process is identified at the 3 cm latereal to the midline under ultrasound guidance. 22 gauge Touhy needle is advanced cephalocaudally to the tip of T5 transverse proscess with in-plane technique. 20ml of 0.5% ropivacaine is injected at the tip of T5 transverse process checking the injectate spreading deep to the erector spinae muscle. After single injection ESPB, the surgery is carried out.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J98.48)Other disorders of lung
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~65Year
	Description American Society of Anesthesiologists physical status 1,2
Exclusion Criteria	Patients with previous history of thoracic surgery Patients with chronic pain disease Patients who have recently used opioids, corticosteroids or any other analgesic drugs Patients who have hepatic or renal disease Patients who have evidence of infection at the area of block procedure Patient with coagulation disorders Pregnant women Patient with known allergies to the drugs used in this study (local anesthetics, codein, acetaminophen, nefopam, nonsteroidal antiinflammatory drugs, tramadol, opioids)
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 (Numeric rating scale)
Timepoint	after emergence from general anesthesia, 1,2,6,24 hour after surgery
Secondary Outcome(s) 1
Outcome	total dosage of rescue analgesics
Timepoint	1,2,6,24 hour 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

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	Not provided at time of Registration

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