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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


N/A
18 Years
65 Years
Not Enrolling
Female
Benign Female Reproductive System Neoplasm

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

morphine-sparing effect of parecoxib

Outcome Description:

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.

Outcome Time Frame:

within 48 h after skin closure

Safety Issue:

No

Principal Investigator

Wenqi Huang, postgraduate

Investigator Role:

Study Chair

Investigator Affiliation:

The First Affliated Hospital, Sun Yet-Sen University

Authority:

China: Ethics Committee

Study ID:

PCEA

NCT ID:

NCT01566669

Start Date:

June 2009

Completion Date:

May 2010

Related Keywords:

  • Benign Female Reproductive System Neoplasm
  • Cyclooxygenase inhibitors
  • Morphine
  • Analgesia
  • patient-controlled
  • Gynecologic surgical procedures
  • Neoplasms
  • Genital Neoplasms, Female

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