Clinical trial NCT03391570: Comparing Postoperative Pain Following COX-2 and Prostanoids Expression
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Genital Disease
Keywords: Laparoscopic surgery
COX-2 inhibitor
Celecoxib
Prostanoid
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Change of biomarkers expression according to exposure to CO2 gas
timeFrame: Peritoneal biopsy will be done twice (intraoperative, at right after trocar insertion and right before trocar removal, an average of 2-3hours)
Secondary outcomes:
measure: Visual analogue scale(VAS) score
timeFrame: every six hours for 48 hours
measure: Numbers of rescue analgesia
timeFrame: From postoperation state to discharge (up to 2 days)
measure: Postoperative complication
timeFrame: From postoperation state to discharge (up to 2 days)
measure: Duration of hospitalization
timeFrame: From postoperation state to discharge (up to 2 days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: