Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT01393925

First received: July 11, 2011

Last updated: November 19, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 11, 2011
Last Updated Date	November 19, 2011
Start Date ^ICMJE	July 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 12, 2011)	The incidence of shoulder pain [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01393925 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Anti-Inflammatory Agents, Non-Steroidal Pain, Postoperative Laparoscopy
Intervention ^ICMJE	Drug: parecoxib parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously
Study Arm (s)	Experimental: parecoxib, normal saline Intervention: Drug: parecoxib
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	126
Completion Date	November 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01393925
Other Study ID Numbers ^ICMJE	FirstSunYetSen
Has Data Monitoring Committee	Yes
Responsible Party	Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor ^ICMJE	First Affiliated Hospital, Sun Yat-Sen University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	First Affiliated Hospital, Sun Yat-Sen University
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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