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

NCT ID: NCT01843010

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-11-30

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.

Conditions

Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Parecoxib

Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery.

Group Type: ACTIVE_COMPARATOR

Parecoxib

Intervention Type: DRUG

Parecoxib 40mg will be intravenously infused.

Placebo

Normal saline 5ml will be intravenously infused at the same time points., respectively.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline 5ml will be intravenously infused.

Interventions

Parecoxib

Parecoxib 40mg will be intravenously infused.

Intervention Type: DRUG

Placebo

Normal saline 5ml will be intravenously infused.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Xuyu Zhang

Attending Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ke xuan Liu, M.D and Ph.D

Role: STUDY_DIRECTOR

1st affiliated hospital of Sun Yat-sen university

Locations

Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University.

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 23136538 (View on PubMed)

Other Identifiers

ZSYY-2013-04-23

Identifier Type: -

Identifier Source: org_study_id