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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies

Intervention / Treatment
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* Drug: Parecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parecoxib<br>Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery. | Drug: Parecoxib<br>* Parecoxib 40mg will be intravenously infused.<br>|
| Placebo Comparator: Placebo<br>Normal saline 5ml will be intravenously infused at the same time points., respectively. | Drug: Placebo<br>* Normal saline 5ml will be intravenously infused.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of shoulder pressure pain threshold | 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. | The pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of shoulder pain | 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. | At the day before surgery, 24h and 48h after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAIDs, Hyperalgesia, Postlaparoscopic shoulder pain