Comparing Postoperative Pain Following COX-2 and Prostanoids Expression

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Female Genital Disease

Intervention / Treatment
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* Drug: COX-2 inhibitor
* Drug: Placebo Oral Tablet
* Procedure: Preoperative peritoneal biopsy
* Procedure: Single-port laparoscopic surgery
* Procedure: Postoperative peritoneal biopsy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COX-2 inhibitor (Celecoxib)<br>Celebrex; COX-2 inhibitor | Drug: COX-2 inhibitor<br>* Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery<br>Procedure: Preoperative peritoneal biopsy<br>* Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)<br>Procedure: Single-port laparoscopic surgery<br>* Single-port laparoscopic surgery with CO2 gas<br>Procedure: Postoperative peritoneal biopsy<br>* Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)<br>|
| Placebo Comparator: Placebo drug (Ramnos)<br>Ramnos; Lactobacillus casei variety rhamnosus | Drug: Placebo Oral Tablet<br>* Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery<br>Procedure: Preoperative peritoneal biopsy<br>* Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)<br>Procedure: Single-port laparoscopic surgery<br>* Single-port laparoscopic surgery with CO2 gas<br>Procedure: Postoperative peritoneal biopsy<br>* Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale(VAS) score | Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10) | every six hours for 48 hours | 
| Numbers of rescue analgesia | Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg) | From postoperation state to discharge (up to 2 days) | 
| Postoperative complication | nausea, vomiting, etc. | From postoperation state to discharge (up to 2 days) | 
| Duration of hospitalization | duration of hospitalization | From postoperation state to discharge (up to 2 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic surgery, COX-2 inhibitor, Celecoxib, Prostanoid