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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01843010
First Posted: April 30, 2013
Last Update Posted: February 19, 2014
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.
Information provided by (Responsible Party):
Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University
April 23, 2013
April 30, 2013
February 19, 2014
May 2013
November 2013   (Final data collection date for primary outcome measure)
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 ]
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.
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 ]
The patients keep sitting postion, 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.
Complete list of historical versions of study NCT01843010 on ClinicalTrials.gov Archive Site
The severity of shoulder pain [ Time Frame: At the day before surgery, 24h and 48h after surgery ]
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.
Same as current
Not Provided
Not Provided
 
Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies
  • Drug: Parecoxib
    Parecoxib 40mg will be intravenously infused.
  • Drug: Placebo
    Normal saline 5ml will be intravenously infused.
  • Active Comparator: Parecoxib
    Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery.
    Intervention: Drug: Parecoxib
  • Placebo Comparator: Placebo
    Normal saline 5ml will be intravenously infused at the same time points., respectively.
    Intervention: Drug: Placebo
Zhang H, Shu H, Yang L, Cao M, Zhang J, Liu K, Xiao L, Zhang X. Multiple-, but not single-, dose of parecoxib reduces shoulder pain after gynecologic laparoscopy. Int J Med Sci. 2012;9(9):757-65. doi: 10.7150/ijms.4916. Epub 2012 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
November 2013
November 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01843010
ZSYY-2013-04-23
Yes
Not Provided
Not Provided
Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital, Sun Yat-Sen University
Not Provided
Study Director: Ke xuan Liu, M.D and Ph.D 1st affiliated hospital of Sun Yat-sen university
First Affiliated Hospital, Sun Yat-Sen University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP