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

Phase 4

Completed

• Conditions: Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies
• Interventions: Drug: Parecoxib; Drug: Placebo

• Registration Number: NCT01843010
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-30
• Study Start: 2013-05
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-15
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parecoxib	Parecoxib	Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery.
Placebo	Placebo	Normal saline 5ml will be intravenously infused at the same time points., respectively.

Primary Outcome Measures

Name	Time	Method
The change of shoulder pressure pain threshold	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.

Secondary Outcome Measures

Name	Time	Method
The severity of shoulder pain	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.

Trial Locations

Locations (1)

Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University.; 🇨🇳 Guangzhou, Guangdong, China