Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
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.