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Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.

Primary Purpose

Anti-Inflammatory Agents, Non-Steroidal, Pain, Postoperative, Laparoscopy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
parecoxib
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti-Inflammatory Agents, Non-Steroidal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology,,The first affiliated hospital of Sun Yat-Sen university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

parecoxib, normal saline

Arm Description

Outcomes

Primary Outcome Measures

The incidence of shoulder pain

Secondary Outcome Measures

Full Information

First Posted
July 11, 2011
Last Updated
November 19, 2011
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01393925
Brief Title
Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-Inflammatory Agents, Non-Steroidal, Pain, Postoperative, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
parecoxib, normal saline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
parecoxib
Intervention Description
parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously
Primary Outcome Measure Information:
Title
The incidence of shoulder pain
Time Frame
up to 15 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Anesthesiology,,The first affiliated hospital of Sun Yat-Sen university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.

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