Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01843010
First received: April 23, 2013
Last updated: February 15, 2014
Last verified: February 2014
  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, estimated 120 patients will be involved in this study. All eligible patients will be randomly assigned to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive normal saline at the same time points. The shoulder pressure pain thresholds will be measured with a pressure algometer by an independent doctor blinding to medication and grouping at the day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At the end of the observation, the intensity of the maximal shoulder pain will be assessed.


Condition Intervention Phase
Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies
Drug: Parecoxib
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies

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

Primary Outcome Measures:
  • The change of shoulder pressure pain threshold [ Time Frame: The pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery ] [ Designated as safety issue: No ]
    The patients keep sitting position, and the pressure pain thresholds are measured twice at a fixed point in bilateral levator scapulae, supraspinatus, pectoralis major and flexor carpi ulnaris with a pressure algometer (FPX25, Wagner Instruments, USA) by an independent doctor.


Secondary Outcome Measures:
  • The severity of shoulder pain [ Time Frame: At the day before surgery, 24h and 48h after surgery ] [ Designated as safety issue: No ]
    The patients are asked to rate the severity of shoulder pain via a visual analog scale (VAS) ranging from no pain (0) to worst possible pain (10) by another independent doctor.


Enrollment: 140
Study Start Date: May 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Parecoxib
Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery.
Drug: Parecoxib
Parecoxib 40mg will be intravenously infused.
Placebo Comparator: Placebo
Normal saline 5ml will be intravenously infused at the same time points., respectively.
Drug: Placebo
Normal saline 5ml will be intravenously infused.

  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)I-II,
  • Body Mass Index(BMI) 18-25kg/m2.

Exclusion Criteria:

  • 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;
  • patient's pain evaluation is judged unreliable;
  • patients with conversion to a laparotomy;
  • refuse to coordinate with the follow-up tests.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843010

Locations
China, Guangdong
Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University.
Guangzhou, Guangdong, China, 510089
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Director: Ke xuan Liu, M.D and Ph.D 1st affiliated hospital of Sun Yat-sen university
  More Information

Publications:
Responsible Party: Xuyu Zhang, Attending Doctor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01843010     History of Changes
Other Study ID Numbers: ZSYY-2013-04-23
Study First Received: April 23, 2013
Last Updated: February 15, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
NSAIDs
Hyperalgesia
Postlaparoscopic shoulder pain

Additional relevant MeSH terms:
Pain, Postoperative
Shoulder Pain
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
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 April 17, 2014