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Laparoscopic Gas Pressure and Postoperative Pain Score

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ClinicalTrials.gov Identifier: NCT03623399
Recruitment Status : Unknown
Verified August 2018 by Seda Yuksel Simsek, Baskent University.
Recruitment status was:  Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Seda Yuksel Simsek, Baskent University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Laparoscopy Procedure: low gas pressure laparoscopy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does Laparoscopic Entrance and Intraoperative Intraabdominal Gas Pressure Effect Postoperative Pain Score
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019
Arms and Interventions
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Arm Intervention/treatment
No Intervention: 15 mmhg-15mmhg
Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 15 mmhg.
15 mmhg-12 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

 Procedure: low gas pressure laparoscopy
To apply different CO2 entrance and intraoperative pressures
12 mmhg-12 mmhg

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

 Procedure: low gas pressure laparoscopy
To apply different CO2 entrance and intraoperative pressures


Outcome Measures
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Primary Outcome Measures :
  1. postoperative pain scores [ Time Frame: Postoperative 6 th hour ]
    Difference between pain scores of participitants according to differing gas pressures applied.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • benign gynecologic pathologies which requires laparoscopic surgery

Exclusion Criteria:

  • patients who has malign gynecologic pathologies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623399


Contacts
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Contact: Seda YUKSEL SIMSEK, M.D. +905359112244 dryukselseda@hotmail.com
Contact: Erhan SIMSEK, Ass. Prof. +905334146299 drsimsekerhan@hotmail.com

Locations
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Turkey
Seda Yuksel Simsek Recruiting
Adana, Turkey, 001
Contact: Erhan Simsek, Ass. Prof.    +905334146299    drsimsekerhan@hotmail.com   
Contact: Husnu Celik, Prof.    +905323257093    drhusnucelik@gmail.com   
Sponsors and Collaborators
Seda Yuksel Simsek
Investigators
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Study Chair: Husnu Celık, Prof. Baskent University
More Information
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Publications:

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Responsible Party: Seda Yuksel Simsek, Gynecology Specialist, Baskent University
ClinicalTrials.gov Identifier: NCT03623399    
Other Study ID Numbers: Baskent University
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: primary outcomes of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seda Yuksel Simsek, Baskent University:
postoperative pain
Intraabdominal laparoscopic gas pressure
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations