Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery (PCEA)
|ClinicalTrials.gov Identifier: NCT01566669|
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : September 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Benign Female Reproductive System Neoplasm||Drug: Parecoxib Sodium Drug: Normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||294 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||June 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Placebo Comparator: Normal Saline
Before incision, patients in controlled Group received NS
Drug: Normal saline
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.
Other Name: NS
Experimental: parecoxib sodium
Before incision, parecoxib patients received 40mg of parecoxib IV
Drug: Parecoxib Sodium
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.
Other Name: Dynastat
- morphine-sparing effect of parecoxib [ Time Frame: 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.
- pain intensity and side effects accompanied with PCEA and parecoxib [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566669
|The First Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|
|Study Chair:||Wenqi Huang, postgraduate||The First Affliated Hospital, Sun Yet-Sen University|