Comparing Postoperative Pain Following COX-2 and Prostanoids Expression
- Conditions
- Female Genital Disease
- Interventions
- Drug: COX-2 inhibitorDrug: Placebo Oral TabletProcedure: Preoperative peritoneal biopsyProcedure: Single-port laparoscopic surgeryProcedure: Postoperative peritoneal biopsy
- Registration Number
- NCT03391570
- Lead Sponsor
- Seoul National University Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COX-2 inhibitor (Celecoxib) COX-2 inhibitor Celebrex; COX-2 inhibitor COX-2 inhibitor (Celecoxib) Preoperative peritoneal biopsy Celebrex; COX-2 inhibitor COX-2 inhibitor (Celecoxib) Single-port laparoscopic surgery Celebrex; COX-2 inhibitor COX-2 inhibitor (Celecoxib) Postoperative peritoneal biopsy Celebrex; COX-2 inhibitor Placebo drug (Ramnos) Placebo Oral Tablet Ramnos; Lactobacillus casei variety rhamnosus Placebo drug (Ramnos) Preoperative peritoneal biopsy Ramnos; Lactobacillus casei variety rhamnosus Placebo drug (Ramnos) Single-port laparoscopic surgery Ramnos; Lactobacillus casei variety rhamnosus Placebo drug (Ramnos) Postoperative peritoneal biopsy Ramnos; Lactobacillus casei variety rhamnosus
- Primary Outcome Measures
Name Time Method Change of biomarkers expression according to exposure to CO2 gas Peritoneal biopsy will be done twice (intraoperative, at right after trocar insertion and right before trocar removal, an average of 2-3hours) Peritoneal biopsy and real-time polymerase chain reaction(RT-PCR), Immunohistochemistry of Biomarkers (COX-2, PGE2, PGF2, PGI2, TXA2)
- Secondary Outcome Measures
Name Time Method Visual analogue scale(VAS) score every six hours for 48 hours Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10)
Numbers of rescue analgesia From postoperation state to discharge (up to 2 days) Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg)
Postoperative complication From postoperation state to discharge (up to 2 days) nausea, vomiting, etc.
Duration of hospitalization From postoperation state to discharge (up to 2 days) duration of hospitalization
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of