Laparoscopic Gas Pressure and Postoperative Pain Score

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03623399
• Other study ID #: Baskent University
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: May 2019

Study information

• Verified date: August 2018
• Source: Baskent University
• Contact: Seda YUKSEL SIMSEK, M.D.
• Phone: +905359112244
• Email: dryukselseda[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• benign gynecologic pathologies which requires laparoscopic surgery

Exclusion Criteria:

• patients who has malign gynecologic pathologies

Related Conditions & MeSH terms

• Laparoscopy
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Seda Yuksel Simsek	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Seda Yuksel Simsek

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain scores	Difference between pain scores of participitants according to differing gas pressures applied.	Postoperative 6 th hour