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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
  Purpose

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 Intervention
Anti-Inflammatory Agents, Non-Steroidal
Pain, Postoperative
Laparoscopy
 Drug: parecoxib

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • The incidence of shoulder pain [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: July 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: parecoxib, normal saline Drug: parecoxib
parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393925

Locations
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
  More Information

No publications provided

Responsible Party: Xuyu Zhang, Attending doctor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01393925     History of Changes
Other Study ID Numbers: FirstSunYetSen
Study First Received: July 11, 2011
Last Updated: November 19, 2011
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on June 17, 2013