Clinical trial NCT01843010: Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
Official title: Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies
Keywords: NSAIDs
Hyperalgesia
Postlaparoscopic shoulder pain
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: The change of shoulder pressure pain threshold
timeFrame: The pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery
Secondary outcomes:
measure: The severity of shoulder pain
timeFrame: At the day before surgery, 24h and 48h after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University.
state: Guangdong
Study officials:
affiliation: 1st affiliated hospital of Sun Yat-sen university
name: Ke xuan Liu, M.D and Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.