Back to resultsLaparoscopic Gas Pressure and Postoperative Pain Score
Primary Purpose
Postoperative Pain, Laparoscopy
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
low gas pressure laparoscopy
Sponsored by
About this trial
This is an interventional other trial for Postoperative Pain focused on measuring postoperative pain, Intraabdominal laparoscopic gas pressure
Eligibility Criteria
Inclusion Criteria:
- benign gynecologic pathologies which requires laparoscopic surgery
Exclusion Criteria:
- patients who has malign gynecologic pathologies
Sites / Locations
- Seda Yuksel SimsekRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Other
Other
Arm Label
15 mmhg-15mmhg
15 mmhg-12 mmhg
12 mmhg-12 mmhg
Arm Description
Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 15 mmhg.
Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg. Low gas pressure laparoscopy
Abdominal entrance pressure will be set to 12 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg. Low gas pressure laparoscopy
Outcomes
Primary Outcome Measures
postoperative pain scores
Difference between pain scores of participitants according to differing gas pressures applied.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03623399
Brief Title
Laparoscopic Gas Pressure and Postoperative Pain Score
Official Title
Does Laparoscopic Entrance and Intraoperative Intraabdominal Gas Pressure Effect Postoperative Pain Score
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seda Yuksel Simsek
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
Aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (CO2) pressures on the extent of postoperative pain scores.
Detailed Description
In this study investigator planned to randomize patients into three groups ; in the first group abdominal entrance pressure will be 15 mmhg and intraoperative pressure will be 15 mmhg too ; in the second group again entrance pressure will be 15 mmhg , intraoperative pressure will be 12 mmhg ; and in the thirth group both entrance and intraoperative pressures will be 12 mmhg. During operation intraoperative mean pressures will be recorded every 15 minutes , also end tidal CO2 pressures will also assesed by the anesthesiologist. Every participant will take , same standard analgesics ; 2 mg/kg contramal and 1 gr i.v. paracetamol at the end of the operation ; except the ones who has allergy to these analgesics. At postoperative 6 th and 24 th hours patients will be asked to execute the visual analogue score (VAS) form to assess the pain . Only patients with benign gynecologic pathologies will be included in to the study and informed consent forms will be taken from all participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Laparoscopy
Keywords
postoperative pain, Intraabdominal laparoscopic gas pressure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
15 mmhg-15mmhg
Arm Type
No Intervention
Arm Description
Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 15 mmhg.
Arm Title
15 mmhg-12 mmhg
Arm Type
Other
Arm Description
Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg.
Low gas pressure laparoscopy
Arm Title
12 mmhg-12 mmhg
Arm Type
Other
Arm Description
Abdominal entrance pressure will be set to 12 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg.
Low gas pressure laparoscopy
Intervention Type
Procedure
Intervention Name(s)
low gas pressure laparoscopy
Intervention Description
To apply different CO2 entrance and intraoperative pressures
Primary Outcome Measure Information:
Title
postoperative pain scores
Description
Difference between pain scores of participitants according to differing gas pressures applied.
Time Frame
Postoperative 6 th hour
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
benign gynecologic pathologies which requires laparoscopic surgery
Exclusion Criteria:
patients who has malign gynecologic pathologies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seda YUKSEL SIMSEK, M.D.
Phone
+905359112244
Email
dryukselseda@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Erhan SIMSEK, Ass. Prof.
Phone
+905334146299
Email
drsimsekerhan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Husnu Celık, Prof.
Organizational Affiliation
Baskent University
Official's Role
Study Chair
Facility Information:
Facility Name
Seda Yuksel Simsek
City
Adana
ZIP/Postal Code
001
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erhan Simsek, Ass. Prof.
Phone
+905334146299
Email
drsimsekerhan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Husnu Celik, Prof.
Phone
+905323257093
Email
drhusnucelik@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
primary outcomes of the study
Citations:
PubMed Identifier
16076335
Citation
Koc M, Ertan T, Tez M, Kocpinar MA, Kilic M, Gocmen E, Aslar AK. Randomized, prospective comparison of postoperative pain in low- versus high-pressure pneumoperitoneum. ANZ J Surg. 2005 Aug;75(8):693-6. doi: 10.1111/j.1445-2197.2005.03496.x.
Results Reference
background
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Laparoscopic Gas Pressure and Postoperative Pain Score
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