Laparoscopic Gas Pressure and Postoperative Pain Score

August 8, 2018 updated by: Seda Yuksel Simsek

Does Laparoscopic Entrance and Intraoperative Intraabdominal Gas Pressure Effect Postoperative Pain Score

Aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (CO2) pressures on the extent of postoperative pain scores.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • benign gynecologic pathologies which requires laparoscopic surgery

Exclusion Criteria:

  • patients who has malign gynecologic pathologies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain scores
Time Frame: Postoperative 6 th hour
Difference between pain scores of participitants according to differing gas pressures applied.
Postoperative 6 th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seda Yuksel Simsek

Investigators

  • Study Chair: Husnu Celık, Prof., Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 7, 2018

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

May 1, 2019

Study Registration Dates

First Submitted

August 5, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (ACTUAL)

August 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Baskent University (Other Identifier: Baskent University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

primary outcomes of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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