Comparing Postoperative Pain Following COX-2 and Prostanoids Expression (COX2RCT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Female Genital Disease
• Intervention / Treatment: Drug: COX-2 inhibitor; Procedure: Preoperative peritoneal biopsy; Procedure: Single-port laparoscopic surgery; Procedure: Postoperative peritoneal biopsy; Drug: Placebo Oral Tablet

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee Seung Kim, PhD; Phone Number: 82-2-2072-4863; Email: bboddi0311@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hee Seung Kim, PhD; Phone Number: 82-2-2072-4863; Email: bboddi0311@gmail.com
    • Contact: Eunji Lee, MD; Phone Number: 82-2-2072-2643; Email: bliss8880103@gmail.com
    • Principal Investigator: Hee Seung Kim, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hee Seung Kim, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: December 30, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: December 30, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; COX-2 inhibitor; Celecoxib; Prostanoid
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors
• Other Study ID Numbers: 2017-1477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No