- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01393925
Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
November 19, 2011 updated by: Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University
This prospective, double blind, placebo-controlled, parallel group study will be conducted in the first affiliated hospital of Sun yat-sen university in Guangzhou, China.
Patients aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia will be involved in this study.
According to previous studies and our pilot trial, the sample size was estimated to be 120 subjects.
All eligible patients will be randomly assigned to one of three groups: Group A (single parecoxib) receiving parecoxib 40mg at 30min before the end of surgery; Group B (multiple parecoxib) receiving parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, respectively, and Group C (Control group) receiving normal saline.
All patients will be managed by a standard propofol-remifentanil based total intravenous anesthesia protocol.
The incidence and intensity of shoulder pain at rest and with motion will be evaluated by an independent doctor blinding to medication and grouping using visual analog scale (VAS) at 6h, 24h and 48h postoperatively.
Other types of pain (e.g.
trocar wound and visceral pain), side effects (such as postoperative nausea and vomiting, itching, dizziness, and oversedation) will be assessed as well.
At the end of the observation, the intensity of the maximum pain will be recorded, and the effect of shoulder pain on the four variables regarding to quality of life (activity, mood, walking and sleep) will be assessed using modified Brief Pain Inventory(BPI) questionnaire.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Department of Anesthesiology,,The first affiliated hospital of Sun Yat-Sen university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- females age 18-65yr
- American Society of Anesthesiologists (ASA) physical status classification I-II
- Body Mass Index(BMI) 18-25kg/m2
- scheduled for elective gynecologic laparoscopic surgery
Exclusion Criteria:
- patients with a history of severe cardiac, pulmonary, hepatic, renal disease, chronic drug or alcohol abuse;
- the presence of preoperative shoulder pain or any chronic pain syndrome, long-term use of analgesics;
- allergy or contraindications to nonsteroidal anti-inflammatory drugs (allergy, peptic ulcer disease, gastroesophageal reflux disease, renal insufficiency, coagulopathy) and any other drugs used in the study;
- those whose pain evaluation was judged unreliable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: parecoxib, normal saline
|
parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of shoulder pain
Time Frame: up to 15 weeks
|
up to 15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
July 11, 2011
First Submitted That Met QC Criteria
July 12, 2011
First Posted (Estimate)
July 13, 2011
Study Record Updates
Last Update Posted (Estimate)
November 22, 2011
Last Update Submitted That Met QC Criteria
November 19, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Parecoxib
Other Study ID Numbers
- FirstSunYetSen
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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