Symptoms and General Pathology

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Genetic Diseases, Inborn

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Intestinal Diseases

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Duodenal Neoplasms

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Gastrointestinal Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Ursodeoxycholic Acid

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Enzyme Inhibitors

Patients receive oral celecoxib twice daily and oral placebo twice daily

Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily

Celecoxib: 400mg twice daily, orally, 6 months

Ursodeoxycholic acid: orally, 6 months, dosage based on body weight:

below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses

Ursodeoxycholic acid

Placebo: orally, 6 months, dosage based on body weight:

below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses

Placebo

Fokko M Nagengast, MD, Ph D

Bjorn WH van Heumen, MD

Wilbert HM Peters, Ph D

Ellen Kampman, Ph D

Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.

Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)

Dutch Cancer Society

Radboud University Medical Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

Ropivacaine

Morphine

Parecoxib

Before incision, patients in controlled Group received NS

Before incision, parecoxib patients received 40mg of parecoxib IV

Before incision, patients in Group P (n = 120) receive 40mg of parecoxib IV. Thereafter, parecoxib patients receive 40mg of parecoxib IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.

Parecoxib Sodium

Before incision, patients in Group C (n = 120) receive 2 mL of normal saline IV. Thereafter, they receive 2 mL of normal saline IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.

Normal saline

Wenqi Huang, postgraduate

The purpose of this study is to determine the effects of parecoxib in combination with epidural morphine in providing analgesia for patients undergoing gynecological surgery.

Researches have showed that the use of epidural and spinal block resulted in significant reduction in morbidity and mortality after surgery. Moreover, appropriate pain management results in better outcomes. Opioids therapy is recommended as the first choice medication for the management of postoperative pain but is associated with a number of undesirable adverse effects. A multimodal therapy for providing postoperative analgesia has advantages over the use of opioids alone. The use of NSAIDs and opioids together often improves analgesia and reduces the need for opioids in the postoperative period. Often, the combination of COX-2 inhibitors with epidural analgesia is preferred. With epidural analgesia, addition of COX-2 inhibitors may improve the analgesia and decrease the undesirable side effects.

Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery

A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of Intravenous Parecoxib Sodium on Morphine Patient-controlled Epidural Analgesia After Gynecologic Surgery

The primary end-point of this study was to quantify the morphine-sparing effect of a multimodal approach containing parecoxib compared with the standard PCEA approach in patients undergoing abdominal hysterectomy.

The secondary outcome included pain intensity, the patients' global evaluation, and side effects accompanied with PCEA and parecoxib, such as nausea, vomiting, pruritus, sedation, motor block in the lower extremities, and the time to passage of flatus and first bowel movement.Blood loss, length of hospitalization, and postoperative cardiovascular (CV) events were also recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis	NCT00808743	Familial Adenom... Duodenal Neopla... Duodenal Polyps	Celecoxib Ursodeoxycholic... Placebo	18 Years - 70 Years	Radboud University Medical Center
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis	NCT00808743	Familial Adenom... Duodenal Neopla... Duodenal Polyps	Celecoxib Ursodeoxycholic... Placebo	18 Years - 70 Years	Radboud University Medical Center
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery	NCT01566669	Benign Female R...	Parecoxib Sodiu... Normal saline	18 Years - 65 Years	First Affiliated Hospital, Sun Yat-Sen University
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery	NCT01566669	Benign Female R...	Parecoxib Sodiu... Normal saline	18 Years - 65 Years	First Affiliated Hospital, Sun Yat-Sen University

Spots Global Cancer Trial Database for cyclooxygenase inhibitors