Clinical trial · Interventional
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
NCT01566669CI-TRIAL-00008112PCEAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Female Reproductive System Neoplasm | Benign Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Normal saline | Drug | — | UNRESOLVED |
| Parecoxib Sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Normal Saline
- description
- Before incision, patients in controlled Group received NS
- interventionNames
- Drug: Normal saline
- type
- EXPERIMENTAL
- label
- parecoxib sodium
- description
- Before incision, parecoxib patients received 40mg of parecoxib IV
- interventionNames
- Drug: Parecoxib Sodium
Primary outcomes (1)
- measure
- morphine-sparing effect of parecoxib
- timeFrame
- within 48 h after skin closure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLiu 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. PMID 27622453