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

NCT01843010 | Completed Phase 4 DMC

• 1 other identifier: ZSYY-2013-04-23
• Study Type: interventional
• Target: 140
• 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, 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.

Conditions

Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies

Keywords

NSAIDs; Hyperalgesia; Postlaparoscopic shoulder pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The severity of shoulder pain

  At the day before surgery, 24h and 48h after surgery

Study Arms (2)

Parecoxib

ACTIVE COMPARATOR

Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery.

Drug: Parecoxib

Placebo

PLACEBO COMPARATOR

Normal saline 5ml will be intravenously infused at the same time points., respectively.

Drug: Placebo

Interventions

Parecoxib DRUG

Parecoxib 40mg will be intravenously infused.

Parecoxib

Placebo DRUG

Normal saline 5ml will be intravenously infused.

Placebo

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)I-II,
• Body Mass Index(BMI) 18-25kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Guangzhou, Guangdong, 510089, China

Location

Related Publications (1)

• 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.

  PMID: 23136538 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Hyperalgesia

Interventions

parecoxib

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Study Officials

• Ke xuan Liu, M.D and Ph.D

  1st affiliated hospital of Sun Yat-sen university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 30, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

CN (1)