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Comparison of postoperative early recovery between preoperative and postoperative transversus abdominis plane block in male patients undergoing inguinal hernia repair

Status Approved

First Submitted Date

2019/11/28
Registered Date

2019/12/06
Last Updated Date

2020/04/27

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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	KCT0004504
Unique Protocol ID	KC19EESI0703
Public/Brief Title	Optimal timing of transversus abdominis plane block for ambulatory open inguinal herniorrhaphy
Scientific Title	Comparison of postoperative early recovery between preoperative and postoperative transversus abdominis plane block in male patients undergoing inguinal hernia repair
Acronym
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	KC19EESI0703
Approval Date	2019-11-19
Institutional Review Board Name	Catholic Medical Center Clinical Reseach Coordinating Center
Institutional Review Board Address	222, Banpo-daero, Seocho-gu, Seoul
Institutional Review Board Telephone	02-2258-8202
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	Min Suk Chae
Title	Dr
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 BANPO-DAERO, SEOCHO-GU, SEOUL
Contact Person for Public Queries
Name	Jung-Woo Shim
Title	Dr
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 BANPO-DAERO, SEOCHO-GU, SEOUL
Contact Person for Updating Information
Name	Jung-Woo Shim
Title	Dr
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 BANPO-DAERO, SEOCHO-GU, SEOUL

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	2019-11-20 Actual
Target Number of Participant	80
Primary Completion Date
Study Completion Date
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-11-20 ,

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	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Intravenous opioid has been widely used for postoperative analgeisa after inguinal hernia repair. As the population group undergoing inguinal hernia repair is getting older, side effects such as respiratory depression, urinary retention, constipation, pruritus, nausea or vomitting are increasing. Transverse abdominis plane (TAP) block is proven to be effective for postoperative analgeisa after inguinal hernia repair, decreasing requirements of perioperative opioid use. On the other hand, there have been several studies on the optimal timing of regional block for postoperative analgesia - preoperative block or postoperative block. Thus, the aim of this study is to compare postoperative pain and early recovery between preoperative and postoperative TAP block in male patients undergoing inguinal hernia repair.

Study Summary Information

Lay Summary

Intravenous opioid has been widely used for postoperative analgeisa after inguinal hernia repair. As the population group undergoing inguinal hernia repair is getting older, side effects such as respiratory depression, urinary retention, constipation, pruritus, nausea or vomitting are increasing. Transverse abdominis plane (TAP) block is proven to be effective for postoperative analgeisa after inguinal hernia repair, decreasing requirements of perioperative opioid use. 
On the other hand, there have been several studies on the optimal timing of regional block for postoperative analgesia - preoperative block or postoperative block. Thus, the aim of this study is to compare postoperative pain and early recovery between preoperative and postoperative TAP block in male patients undergoing inguinal hernia repair.

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, Caregiver, Outcome Accessor
Allocation	RCT
Intervention Type	Drug
Intervention Description	For postoperative analgesia, TAP block was performed by experienced anesthesiologists postoperatively in the control group or preoperatively in the experimental group. Under the guidance of ultrasound, 20ml of 0.25% ropivacaine was injected in both groups after confirmation of transversus abdominis plane.
Number of Arms	2
Arm 1	Arm Label postoperative TAP block group
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description General anesthesia was performed using 2mg/kg of intravenous propofol after preoperative TAP block. And general anesthesia was maintained by 4 to 6 vol% of inhaled desflurane via endotracheal tube until the end of the surgery. During the surgery, remifentanil was continuously infused at a rate of 0.05~0.15mcg/kg/min. For postoperative analgesia, TAP block was performed after the operation. Under the guidance of ultrasound, 20ml of 0.25% ropivacaine was injected after confirmation of transversus abdominis plane.
Arm 2	Arm Label preoperative TAP block group
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description For postoperative analgesia, TAP block was performed preoperatively. Under the guidance of ultrasound, 20ml of 0.25% ropivacaine was injected after confirmation of transversus abdominis plane. General anesthesia was performed using 2mg/kg of intravenous propofol after performing TAP block. And general anesthesia was maintained by 4 to 6 vol% of inhaled desflurane via endotracheal tube until the end of the surgery. During the surgery, remifentanil was continuously infused at a rate of 0.05~0.15mcg/kg/min.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K40.90)Unilateral or unspecified inguinal hernia, without obstruction or gangrene, not specified as recurrent Inguinal hernia
Rare Disease	No
Inclusion Criteria	Gender Male
	Age 19Year~No Limit
	Description ASA physical status classification 1 or 2
Exclusion Criteria	1. Patients who do not agree to participate in this study 2. Emergency surgery 3. ASA physical status classification 3 or above 4. Preoperative bleeding tendency (INR > 2.0) or taking drugs related to increased bleeding 5. History of allergy to the agents to be administered 6. Intraoperative hemodynamic instability th the extent that colloid infusion/transfusion or vasoactive drugs are necessary
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	Not applicable
Outcome	Scores in the Korean version of the Quality of Recovery-40 questionnaire
Timepoint	at 24 hours after the operation
Secondary Outcome(s) 1
Outcome	Peak Visual analogue scale (VAS) pain score
Timepoint	during 24 hours after the operation
Secondary Outcome(s) 2
Outcome	Rescue pain killer use (time) and VAS pain score (at that time)
Timepoint	during 24 hours after the operation
Secondary Outcome(s) 3
Outcome	VAS pain score , 1, 6, 24 hours after the operation
Timepoint	at 1, 6, 24 hours after the operation
Secondary Outcome(s) 4
Outcome	Complications during 24 hours after the operation
Timepoint	during 24 hours after the operation
Secondary Outcome(s) 5
Outcome	Total hospital stay
Timepoint	At the time of discharge

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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