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

Sun Yat-sen University

Status and phase

Completed

Phase 4

Conditions

Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies

Treatments

Drug: Parecoxib

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01843010

ZSYY-2013-04-23

Details and patient eligibility

About

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.

Enrollment

140 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.