Benign Female Reproductive System Neoplasm
Conditions
Keywords
Cyclooxygenase inhibitors, Morphine, Analgesia, patient-controlled, Gynecologic surgical procedures
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.
Interventions
DRUGParecoxib 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.
DRUGNormal 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.
Sponsors
Guangdong Provincial People's Hospital
Second Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital, Southern Medical University
Liu Weifeng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| morphine-sparing effect of parecoxib | within 48 h after skin closure | 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
| Measure | Time frame | Description |
|---|---|---|
| pain intensity and side effects accompanied with PCEA and parecoxib | within 48 h after skin closure | 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. |
Countries
China
Outcome results
None listed