Comparing Postoperative Pain Following COX-2 and Prostanoids Expression

Female Genital Disease Clinical Trial

— COX2RCT  

Official title:

A Prospective Randomized Clinical Trial for Comparing Postoperative Pain Following COX-2 and Prostanoids Expression in Women Who Underwent Laparoscopic Surgery for Female Genital Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391570
• Other study ID #: 2017-1477
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2017
• Last updated: December 30, 2017
• Start date: October 17, 2017
• Est. completion date: October 2019

Study information

• Verified date: December 2017
• Source: Seoul National University Hospital
• Contact: Hee Seung Kim, PhD
• Phone: 82-2-2072-4863
• Email: bboddi0311[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare postoperative pain following COX-2 and prostanoids expression in women who underwent laparoscopic surgery for female genital disease in order to evaluate the effect of COX-2 on local inflammation, COX-2 and prostanoids expression followed by exposure time to carbon dioxide(CO2) gas, and degree of postoperative pain.

Description:

In women who underwent laparoscopic surgery for female genital disease, the effect of COX-2 on local inflammation was assessed by randomization, using the COX-2 inhibitor celecoxib and placebo, comparative evaluation of expression of COX-2 and prostanoids by pre/postoperative peritoneal biopsy and postoperative pain depending on gas exposure time

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Female, Age = 20 years

• Patients with benign female genital disease who need laparoscopic surgery

• Patients with benign disease who can be treated by single port laparoscopy

• Patients who signed an approved informed consent

Exclusion Criteria:

• Female, Age < 20 years

• Pregnancy

• Previous cancer history

• Patients who refuse to sign an informed consent

• Patients with benign female genital disease combined clinical peritonitis (ex. tubo-ovarian abscess, tubo-ovaritis, ruptured endometriosis)

• Patients with malignant female genital disease

• Patients who got surgery with multi-port laparoscopy

• Patients who are contraindicated with COX-2 inhibitors (liver disease, renal disease, active peptic ulcer, active gastrointestinal tract bleeding, ischemic heart disease, hyperkalemia)

Related Conditions & MeSH terms

• Female Genital Disease
• Genital Diseases, Female
• Pain, Postoperative

Intervention

Drug:
• COX-2 inhibitor
Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery
• Placebo Oral Tablet
Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery

Procedure:
• Preoperative peritoneal biopsy
Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)
• Single-port laparoscopic surgery
Single-port laparoscopic surgery with CO2 gas
• Postoperative peritoneal biopsy
Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of biomarkers expression according to exposure to CO2 gas	Peritoneal biopsy and real-time polymerase chain reaction(RT-PCR), Immunohistochemistry of Biomarkers (COX-2, PGE2, PGF2, PGI2, TXA2)	Peritoneal biopsy will be done twice (intraoperative, at right after trocar insertion and right before trocar removal, an average of 2-3hours)
Secondary	Visual analogue scale(VAS) score	Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10)	every six hours for 48 hours
Secondary	Numbers of rescue analgesia	Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg)	From postoperation state to discharge (up to 2 days)
Secondary	Postoperative complication	nausea, vomiting, etc.	From postoperation state to discharge (up to 2 days)
Secondary	Duration of hospitalization	duration of hospitalization	From postoperation state to discharge (up to 2 days)