Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01393925
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):
Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Anti-Inflammatory Agents, Non-Steroidal Pain, Postoperative Laparoscopy Drug: parecoxib Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: parecoxib, normal saline Drug: parecoxib
parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously

Primary Outcome Measures :
  1. The incidence of shoulder pain [ Time Frame: up to 15 weeks ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01393925

China, Guangdong
Department of Anesthesiology,,The first affiliated hospital of Sun Yat-Sen university
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Xuyu Zhang, Attending doctor, First Affiliated Hospital, Sun Yat-Sen University Identifier: NCT01393925     History of Changes
Other Study ID Numbers: FirstSunYetSen
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents