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

NCT01566669 | Completed

• 1 other identifier: PCEA
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Female Reproductive System Neoplasm

Keywords

Cyclooxygenase inhibitors; Morphine; Analgesia; patient-controlled; Gynecologic surgical procedures

Outcome Measures

Primary Outcomes (1)

• 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.

  within 48 h after skin closure

Secondary Outcomes (1)

• pain intensity and side effects accompanied with PCEA and parecoxib

  within 48 h after skin closure

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Before incision, patients in controlled Group received NS

Drug: Normal saline

parecoxib sodium

EXPERIMENTAL

Before incision, parecoxib patients received 40mg of parecoxib IV

Drug: Parecoxib Sodium

Interventions

Parecoxib Sodium DRUG

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.

Also known as: Dynastat

parecoxib sodium

Normal saline DRUG

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.

Also known as: NS

Normal Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women scheduled for elective gynecological surgery under combined spinal-epidural anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Liu Weifeng: lead
• Guangdong Provincial People's Hospital: collaborator
• Second Affiliated Hospital, Sun Yat-Sen University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 27622453 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

parecoxib; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Wenqi Huang, postgraduate

  The First Affliated Hospital, Sun Yet-Sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: March 18, 2012
• First Posted: March 29, 2012
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

CN (1)