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

Not Applicable

Completed

• Conditions: Benign Female Reproductive System Neoplasm
• Interventions: Drug: Normal saline; Drug: Parecoxib Sodium

• Registration Number: NCT01566669
• Lead Sponsor: Liu Weifeng

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2012-03-18
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 294

Inclusion Criteria

• women scheduled for elective gynecological surgery under combined spinal-epidural anesthesia

Exclusion Criteria

• contraindications for CSE placement
• known allergy, sensitivity, or contraindication to opioid and nonopioid analgesic drugs
• history of bleeding disorders, peptic ulceration, or anticoagulant use within the past month
• current pregnancy or breastfeeding
• history of known or suspected drug abuse
• unable to understand the use of pain assessment scales and the PCA device
• Patient with asthma or bronchospasm, requiring treatment with glucocorticoids
• poorly controlled hypertension or diabetes, a chronic or acute renal or hepatic disorder, or inflammatory bowel disease
• patients had taken antidepressants, narcotic analgesics, antihistamines, anxiolytics, hypnotics, sedatives, NSAIDs, or corticosteroids up to 24 h before receipt of the study medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal saline	Before incision, patients in controlled Group received NS
parecoxib sodium	Parecoxib Sodium	Before incision, parecoxib patients received 40mg of parecoxib IV

Primary Outcome Measures

Name	Time	Method
morphine-sparing effect of parecoxib	within 48 h after skin closure	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.

Secondary Outcome Measures

Name	Time	Method
pain intensity and side effects accompanied with PCEA and parecoxib	within 48 h after skin closure	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China