Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.

NCT01393925 | Completed DMC

• 1 other identifier: FirstSunYetSen
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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, the sample size was estimated to be 120 subjects. All eligible patients will be randomly assigned to one of three groups: Group A (single parecoxib) receiving parecoxib 40mg at 30min before the end of surgery; Group B (multiple parecoxib) receiving parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, respectively, and Group C (Control group) receiving normal saline. All patients will be managed by a standard propofol-remifentanil based total intravenous anesthesia protocol. The incidence and intensity of shoulder pain at rest and with motion will be evaluated by an independent doctor blinding to medication and grouping using visual analog scale (VAS) at 6h, 24h and 48h postoperatively. Other types of pain (e.g. trocar wound and visceral pain), side effects (such as postoperative nausea and vomiting, itching, dizziness, and oversedation) will be assessed as well. At the end of the observation, the intensity of the maximum pain will be recorded, and the effect of shoulder pain on the four variables regarding to quality of life (activity, mood, walking and sleep) will be assessed using modified Brief Pain Inventory(BPI) questionnaire.

Conditions

Anti-Inflammatory Agents, Non-Steroidal; Pain, Postoperative; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• The incidence of shoulder pain

  up to 15 weeks

Study Arms (1)

parecoxib, normal saline

EXPERIMENTAL

Drug: parecoxib

Interventions

parecoxib DRUG

parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously

parecoxib, normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• females age 18-65yr
• American Society of Anesthesiologists (ASA) physical status classification I-II
• Body Mass Index(BMI) 18-25kg/m2
• scheduled for elective gynecologic laparoscopic surgery

You may not qualify if:

• patients with 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;
• those whose pain evaluation was judged unreliable

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Department of Anesthesiology,,The first affiliated hospital of Sun Yat-Sen university

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

parecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 13, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

CN (1)