Laparoscopic Gas Pressure and Postoperative Pain Score

NCT ID: NCT03623399

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-07

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type OTHER

low gas pressure laparoscopy

Intervention Type PROCEDURE

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

Group Type OTHER

low gas pressure laparoscopy

Intervention Type PROCEDURE

To apply different CO2 entrance and intraoperative pressures

Interventions

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low gas pressure laparoscopy

To apply different CO2 entrance and intraoperative pressures

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* benign gynecologic pathologies which requires laparoscopic surgery

Exclusion Criteria

* patients who has malign gynecologic pathologies
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seda Yuksel Simsek

OTHER

Sponsor Role lead

Responsible Party

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Seda Yuksel Simsek

Gynecology Specialist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Husnu Celık, Prof.

Role: STUDY_CHAIR

Baskent University

Locations

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Seda Yuksel Simsek

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Seda YUKSEL SIMSEK, M.D.

Role: CONTACT

+905359112244

Erhan SIMSEK, Ass. Prof.

Role: CONTACT

+905334146299

Facility Contacts

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Erhan Simsek, Ass. Prof.

Role: primary

+905334146299

Husnu Celik, Prof.

Role: backup

+905323257093

References

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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.

Reference Type BACKGROUND
PMID: 16076335 (View on PubMed)

Other Identifiers

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Baskent University

Identifier Type: -

Identifier Source: org_study_id

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