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

This study has been completed.
Sponsor:
Collaborators:
Guangdong General Hospital
Second Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Information provided by (Responsible Party):
Liu Weifeng, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01566669
First received: March 18, 2012
Last updated: September 20, 2012
Last verified: September 2012

March 18, 2012
September 20, 2012
June 2009
May 2010   (final data collection date for primary outcome measure)
morphine-sparing effect of parecoxib [ Time Frame: within 48 h after skin closure ] [ Designated as safety issue: No ]
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.
  • the pain intensity [ Time Frame: within 48 h after skin closure ] [ Designated as safety issue: No ]
    Pain intensity was recorded on a 100-mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (the most severe pain possible) and measured at rest (VAS-R) and with activity (VAS-A). Pain with activity was elicited by asking the patient to take a deep breath followed by a forceful cough. A pain assessment was obtained immediately after the cough.
  • the self-administration of PCEA [ Time Frame: within 48 h after skin closure ] [ Designated as safety issue: No ]
    The number of bolus injections of PCEA during the postoperative 48 h was recorded, and the need for rescue analgesic was noted.
Complete list of historical versions of study NCT01566669 on ClinicalTrials.gov Archive Site
pain intensity and side effects accompanied with PCEA and parecoxib [ Time Frame: within 48 h after skin closure ] [ Designated as safety issue: Yes ]
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.
side effects [ Time Frame: within 48 h after skin closure ] [ Designated as safety issue: Yes ]
side effects, including nausea, vomiting, pruritus, recovery of gastrointestinal function, blood loss, et al.
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Benign Female Reproductive System Neoplasm
  • 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
  • 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
  • Placebo Comparator: Normal Saline
    Before incision, patients in controlled Group received NS
    Intervention: Drug: Normal saline
  • Experimental: parecoxib sodium
    Before incision, parecoxib patients received 40mg of parecoxib IV
    Intervention: Drug: Parecoxib Sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
294
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01566669
PCEA
No
Liu Weifeng, First Affiliated Hospital, Sun Yat-Sen University
Liu Weifeng
  • Guangdong General Hospital
  • Second Affiliated Hospital, Sun Yat-Sen University
  • Nanfang Hospital of Southern Medical University
Study Chair: Wenqi Huang, postgraduate The First Affliated Hospital, Sun Yet-Sen University
First Affiliated Hospital, Sun Yat-Sen University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP