Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
Primary Purpose
Anti-Inflammatory Agents, Non-Steroidal, Pain, Postoperative, Laparoscopy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
parecoxib
Sponsored by
About this trial
This is an interventional treatment trial for Anti-Inflammatory Agents, Non-Steroidal
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology,,The first affiliated hospital of Sun Yat-Sen university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
parecoxib, normal saline
Arm Description
Outcomes
Primary Outcome Measures
The incidence of shoulder pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01393925
First Posted
July 11, 2011
Last Updated
November 19, 2011
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01393925
Brief Title
Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-Inflammatory Agents, Non-Steroidal, Pain, Postoperative, Laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
parecoxib, normal saline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
parecoxib
Intervention Description
parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously
Primary Outcome Measure Information:
Title
The incidence of shoulder pain
Time Frame
up to 15 weeks
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:
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
Facility Information:
Facility Name
Department of Anesthesiology,,The first affiliated hospital of Sun Yat-Sen university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
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Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
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