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

History of Changes

Purpose

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.

Condition	Intervention
Benign Female Reproductive System Neoplasm	Drug: Parecoxib Sodium Drug: Normal saline

Study Type:	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
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Morphine sulfate

U.S. FDA Resources

Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	294
Study Start Date:	June 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566669

Locations

China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080

Sponsors and Collaborators

Liu Weifeng

Guangdong General Hospital

Second Affiliated Hospital, Sun Yat-Sen University

Nanfang Hospital of Southern Medical University

Investigators

Study Chair:

Wenqi Huang, postgraduate

The First Affliated Hospital, Sun Yet-Sen University

More Information

No publications provided

Responsible Party:	Liu Weifeng, attending doctor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:	NCT01566669 History of Changes
Other Study ID Numbers:	PCEA
Study First Received:	March 18, 2012
Last Updated:	September 20, 2012
Health Authority:	China: Ethics Committee

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:

Cyclooxygenase inhibitors
Morphine
Analgesia
patient-controlled
Gynecologic surgical procedures

Additional relevant MeSH terms:

Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Morphine
Parecoxib
Cyclooxygenase Inhibitors
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Cyclooxygenase 2 Inhibitors
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 17, 2013

To Top