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Laparoscopic Gas Pressure and Postoperative Pain Score

S

Seda Yuksel Simsek

Status

Unknown

Conditions

Postoperative Pain
Laparoscopy

Treatments

Procedure: low gas pressure laparoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT03623399
Baskent University

Details and patient eligibility

About

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

Full 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.

Enrollment

195 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • benign gynecologic pathologies which requires laparoscopic surgery

Exclusion criteria

  • patients who has malign gynecologic pathologies

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

195 participants in 3 patient groups

15 mmhg-15mmhg
No Intervention group
Description:
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
Other group
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
Treatment:
Procedure: low gas pressure laparoscopy
12 mmhg-12 mmhg
Other group
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
Treatment:
Procedure: low gas pressure laparoscopy

Trial contacts and locations

1

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Central trial contact

Erhan SIMSEK, Ass. Prof.; Seda YUKSEL SIMSEK, M.D.

Data sourced from clinicaltrials.gov

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