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NCT Number: NCT01843010

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

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.

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Key information

Conditions

Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies Arthralgia Hyperalgesia Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Shoulder Pain Signs and Symptoms Somatosensory Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University.

Guangzhou, Guangdong, 510089, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parecoxib

Drug

Parecoxib 40mg will be intravenously infused.

Placebo

Drug

Normal saline 5ml will be intravenously infused.

Primary outcomes

  1. 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

  1. The severity of shoulder pain

    Time frame: At the day before surgery, 24h and 48h after surgery

    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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 30, 2013
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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