Comparing Postoperative Pain Following COX-2 and Prostanoids Expression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-17

Study Completion Date

2019-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

NCT03374397

Ovarian Cyst Benign

COMPLETED PHASE3

Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.

NCT01393925

Anti-Inflammatory Agents, Non-Steroidal Pain, Postoperative Laparoscopy

COMPLETED NA

Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain

NCT04793191

Benign Gynecological Disease

COMPLETED

Effect of Preoperative Duloxetine on Quality of Recovery After Outpatient Laparoscopic Surgery

NCT02351440

Quality of Recovery Gynecologic Surgery Laparoscopy

WITHDRAWN PHASE4

Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy

NCT06862947

Gynecological Laparoscopy Postoperative Pain Rectus Sheath Block

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Female Genital Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COX-2 inhibitor (Celecoxib)

Celebrex; COX-2 inhibitor

Group Type ACTIVE_COMPARATOR

COX-2 inhibitor

Intervention Type DRUG

Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery

Preoperative peritoneal biopsy

Intervention Type PROCEDURE

Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Single-port laparoscopic surgery

Intervention Type PROCEDURE

Single-port laparoscopic surgery with CO2 gas

Postoperative peritoneal biopsy

Intervention Type PROCEDURE

Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Placebo drug (Ramnos)

Ramnos; Lactobacillus casei variety rhamnosus

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery

Preoperative peritoneal biopsy

Intervention Type PROCEDURE

Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Single-port laparoscopic surgery

Intervention Type PROCEDURE

Single-port laparoscopic surgery with CO2 gas

Postoperative peritoneal biopsy

Intervention Type PROCEDURE

Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COX-2 inhibitor

Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery

Intervention Type DRUG

Placebo Oral Tablet

Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery

Intervention Type DRUG

Preoperative peritoneal biopsy

Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Intervention Type PROCEDURE

Single-port laparoscopic surgery

Single-port laparoscopic surgery with CO2 gas

Intervention Type PROCEDURE

Postoperative peritoneal biopsy

Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No