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

NCT01843010 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2014-02-19

No results posted yet for this study

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, 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.

Conditions

  • Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies

Interventions

DRUG

Parecoxib

Parecoxib 40mg will be intravenously infused.

DRUG

Placebo

Normal saline 5ml will be intravenously infused.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Ke xuan Liu, M.D and Ph.D · 1st affiliated hospital of Sun Yat-sen university

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01843010 on ClinicalTrials.gov