Laparoscopic Gas Pressure and Postoperative Pain Score

Not Applicable

• Conditions: Laparoscopy; Postoperative Pain
• Interventions: Procedure: low gas pressure laparoscopy

• Registration Number: NCT03623399
• Lead Sponsor: Seda Yuksel Simsek

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.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-05
• Study Start: 2018-08-07
• Study First Submitted QC: 2018-08-08
• Last Update Submitted: 2018-08-08
• Study First Posted: 2018-08-09
• Last Update Posted: 2018-08-09
• Primary Completion: 2019-03
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 195

Inclusion Criteria

• benign gynecologic pathologies which requires laparoscopic surgery

Exclusion Criteria

• patients who has malign gynecologic pathologies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 mmhg-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
15 mmhg-12 mmhg	low gas pressure laparoscopy	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

Primary Outcome Measures

Name	Time	Method
postoperative pain scores	Postoperative 6 th hour	Difference between pain scores of participitants according to differing gas pressures applied.

Trial Locations

Locations (1)

Seda Yuksel Simsek; 🇹🇷 Adana, Turkey