Comparing Postoperative Pain Following COX-2 and Prostanoids Expression

NCT03391570 | Unknown

• 1 other identifier: 2017-1477
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Genital Disease

Keywords

Laparoscopic surgery; COX-2 inhibitor; Celecoxib; Prostanoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual analogue scale(VAS) score

  every six hours for 48 hours

• Numbers of rescue analgesia

  From postoperation state to discharge (up to 2 days)

• Postoperative complication

  From postoperation state to discharge (up to 2 days)

• Duration of hospitalization

  From postoperation state to discharge (up to 2 days)

Study Arms (2)

COX-2 inhibitor (Celecoxib)

ACTIVE COMPARATOR

Celebrex; COX-2 inhibitor

Drug: COX-2 inhibitor; Procedure: Preoperative peritoneal biopsy; Procedure: Single-port laparoscopic surgery; Procedure: Postoperative peritoneal biopsy

Placebo drug (Ramnos)

PLACEBO COMPARATOR

Ramnos; Lactobacillus casei variety rhamnosus

Drug: Placebo Oral Tablet; Procedure: Preoperative peritoneal biopsy; Procedure: Single-port laparoscopic surgery; Procedure: Postoperative peritoneal biopsy

Interventions

COX-2 inhibitor DRUG

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

COX-2 inhibitor (Celecoxib)

Placebo Oral Tablet DRUG

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

Placebo drug (Ramnos)

Preoperative peritoneal biopsy PROCEDURE

Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

COX-2 inhibitor (Celecoxib); Placebo drug (Ramnos)

Single-port laparoscopic surgery PROCEDURE

Single-port laparoscopic surgery with CO2 gas

COX-2 inhibitor (Celecoxib); Placebo drug (Ramnos)

Postoperative peritoneal biopsy PROCEDURE

Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

COX-2 inhibitor (Celecoxib); Placebo drug (Ramnos)

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Han KH, Park S, Lee S, Ham J, Lim W, Song G, Kim HS. Upregulation of 15-Hydroxyprostaglandin Dehydrogenase by Celecoxib to Reduce Pain After Laparoendoscopic Single-Site Surgery (POPCORN Trial): A Randomized Controlled Trial. Biomedicines. 2025 Jul 21;13(7):1784. doi: 10.3390/biomedicines13071784.

  PMID: 40722854 DERIVED

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Cyclooxygenase 2 Inhibitors

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Hee Seung Kim, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Seung Kim, PhD

CONTACT

82-2-2072-4863; bboddi0311@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: January 5, 2018
• Study Start: October 17, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 5, 2018

Record last verified: 2017-12

Locations

KR (1)