Back to resultsThe Effect of Rectus Sheath Block on the Postoperative Analgesia in the Patients Undergoing Robotic Single Port Cholecystectomy
Primary Purpose
Gallbladder Diseases
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
denogan and rectus sheath block
denogan
Sponsored by
About this trial
This is an interventional prevention trial for Gallbladder Diseases
Eligibility Criteria
Inclusion Criteria:
- robotic single Port cholecystectomy for gallbladder disease
Exclusion Criteria:
- Allergy to ropivacaine, infection, history of abdominal surgery, body mass index more than 30
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rectus sheath block group
Control group
Arm Description
administration of denogan rectus sheath block with 0.375% ropivacaine
just administration of denogan
Outcomes
Primary Outcome Measures
Abdominal pain score after surgery
Secondary Outcome Measures
Fentanyl consumption in recovery room
Full Information
NCT ID
NCT02827097
First Posted
July 4, 2016
Last Updated
July 1, 2019
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02827097
Brief Title
The Effect of Rectus Sheath Block on the Postoperative Analgesia in the Patients Undergoing Robotic Single Port Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Study Start Date
October 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this study is to investigate the effect of rectus sheath block on abdominal pain score after robotic single port cholecystectomy.
The secondary purpose of this study is to investigate the effect of rectus sheath block on fentanyl consumption during stay of recovery room after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rectus sheath block group
Arm Type
Experimental
Arm Description
administration of denogan
rectus sheath block with 0.375% ropivacaine
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
just administration of denogan
Intervention Type
Drug
Intervention Name(s)
denogan and rectus sheath block
Intervention Description
administration of denogan and rectus sheath block with 0.375% ropivacaine
Intervention Type
Drug
Intervention Name(s)
denogan
Intervention Description
administration of denogan
Primary Outcome Measure Information:
Title
Abdominal pain score after surgery
Time Frame
Change from baseline abdominal pain score up to 24 hours
Secondary Outcome Measure Information:
Title
Fentanyl consumption in recovery room
Time Frame
Up to 1 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
robotic single Port cholecystectomy for gallbladder disease
Exclusion Criteria:
Allergy to ropivacaine, infection, history of abdominal surgery, body mass index more than 30
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
State/Province
Seoum
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Rectus Sheath Block on the Postoperative Analgesia in the Patients Undergoing Robotic Single Port Cholecystectomy
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