Clinical trial NCT01566669: Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Female Reproductive System Neoplasm
Keywords: Cyclooxygenase inhibitors
Morphine
Analgesia
patient-controlled
Gynecologic surgical procedures
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: Second Affiliated Hospital, Sun Yat-Sen University
name: Nanfang Hospital, Southern Medical University
First posted: 2012-03-29
Enrollment: 294
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: morphine-sparing effect of parecoxib
timeFrame: within 48 h after skin closure
Secondary outcomes:
measure: pain intensity and side effects accompanied with PCEA and parecoxib
timeFrame: within 48 h after skin closure
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The First Affliated Hospital, Sun Yet-Sen University
name: Wenqi Huang, postgraduate
role: STUDY_CHAIR
References:
citation: Liu WF, Shu HH, Zhao GD, Peng SL, Xiao JF, Zhang GR, Liu KX, Huang WQ. Effect of Parecoxib as an Adjunct to Patient-Controlled Epidural Analgesia after Abdominal Hysterectomy: A Multicenter, Randomized, Placebo-Controlled Trial. PLoS One. 2016 Sep 13;11(9):e0162589. doi: 10.1371/journal.pone.0162589. eCollection 2016.