Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- The change of shoulder pressure pain threshold
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Parecoxib
Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery.
Intervention: Parecoxib (Drug)
Placebo
Normal saline 5ml will be intravenously infused at the same time points., respectively.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The change of shoulder pressure pain threshold
Time Frame: 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 Outcomes
- The severity of shoulder pain(At the day before surgery, 24h and 48h after surgery)
Investigators
Xuyu Zhang
Attending Doctor
First Affiliated Hospital, Sun Yat-Sen University