search
Back to results

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

Primary Purpose

Benign Female Reproductive System Neoplasm

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Parecoxib Sodium
Normal saline
Sponsored by
Liu Weifeng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Female Reproductive System Neoplasm focused on measuring Cyclooxygenase inhibitors, Morphine, Analgesia, patient-controlled, Gynecologic surgical procedures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Normal Saline

parecoxib sodium

Arm Description

Before incision, patients in controlled Group received NS

Before incision, parecoxib patients received 40mg of parecoxib IV

Outcomes

Primary Outcome Measures

morphine-sparing effect of parecoxib
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
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.

Full Information

First Posted
March 18, 2012
Last Updated
September 20, 2012
Sponsor
Liu Weifeng
Collaborators
Guangdong Provincial People's Hospital, Second Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT01566669
Brief Title
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery
Acronym
PCEA
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liu Weifeng
Collaborators
Guangdong Provincial People's Hospital, Second Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Female Reproductive System Neoplasm
Keywords
Cyclooxygenase inhibitors, Morphine, Analgesia, patient-controlled, Gynecologic surgical procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
294 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Before incision, patients in controlled Group received NS
Arm Title
parecoxib sodium
Arm Type
Experimental
Arm Description
Before incision, parecoxib patients received 40mg of parecoxib IV
Intervention Type
Drug
Intervention Name(s)
Parecoxib Sodium
Other Intervention Name(s)
Dynastat
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NS
Intervention Description
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.
Primary Outcome Measure Information:
Title
morphine-sparing effect of parecoxib
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.
Time Frame
within 48 h after skin closure
Secondary Outcome Measure Information:
Title
pain intensity and side effects accompanied with PCEA and parecoxib
Description
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.
Time Frame
within 48 h after skin closure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenqi Huang, postgraduate
Organizational Affiliation
The First Affliated Hospital, Sun Yet-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27622453
Citation
Liu 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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs