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

Liu Weifeng

Status: Completed

Conditions: Benign Female Reproductive System Neoplasm

Treatments: Drug: Parecoxib Sodium; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01566669

PCEA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 294 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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294 participants in 2 patient groups, including a placebo group

Normal Saline

Placebo Comparator group

Description:

Before incision, patients in controlled Group received NS

Treatment:

Drug: Normal saline

parecoxib sodium

Experimental group

Description:

Before incision, parecoxib patients received 40mg of parecoxib IV

Treatment:

Drug: Parecoxib Sodium