Optimized Acute Pain Control With Parecoxib in Uniportal Video-assisted Thoracoscopic Surgery.

August 1, 2023 updated by: National Taiwan University Hospital

Perioperative Pain-control With Parecoxib in Uniportal Video-assisted Thoracoscopic Surgery.

Chronic pain after thoracic surgery has been a bothering problem since the era of thoracotomy. The prevalence of chronic pain no matter in thoracotomy or video-assisted thoracoscopic surgery is about 30 to 47%. Better acute pain control after thoracic surgery has been assumed to be an effective way for prevention of chronic pain. Especially in this extreme minimal invasive surgery, uniportal video-assisted thoracic surgery, more optimized perioperative analgesics should be found out. In the guideline of "enhanced recovery after surgery", less opioid is suggested. Other than opioids, there are just few parental analgesics could be used, like acetaminophen or cyclooxygenase-2(COX-2) inhibitor. In our study, the investigators would like to build up a better analgesic strategy for uniportal video-assisted thoracoscopic surgery with less opioid and less side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thoracic surgery has been progressed rapidly from traditional thoracotomy to triportal thoracoscopy, and even uniportal thoracoscopy within past decades. Perioperative pain control is always an important issue for postoperative recovery and prevention of chronic pain. The acute pain is most severe in the first 2 to 4 hours after the surgery until the chest tube removal. This painful sensation might postpone the ambulation time and restrain patient's respiratory depth or ability to cough. Although the surgical wound is getting smaller, the incidence of chronic pain is not declined as presumed. The incidence of chronic pain is highly related to acute pain control. In the guideline of enhanced recovery after lung surgery, multimodal analgesia is recommended. The combination of regional analgesia like thoracic epidural blockade (TEB) or paravertebral nerve blockade (PVB), and medications with different mechanism are beneficial for recovery. Intercostal nerve blockade is also studied and popular in recent years.

However, currently there is no optimal perioperative pain control suggestion for uniportal video-assisted thoracoscopic surgery (VATS). In uniportal VATS, the chest tube is the massive contribution for acute pain, and which is usually removed within postoperative 24 hours. In this study, the investigators would like to use the selective COX-2 inhibitor, parecoxib, combined with intra-operative intercostal nerve blockade for perioperative pain control. Parecoxib is relative long-acting than other currently using parental NSAID medication. The primary outcome is the morphine consumption in parecoxib and placebo groups. The secondary outcome is the numeric rating scale (NRS) during rest and cough, side effects, salvage medications, and chronic pain incidence in 3 months. The investigators hypothesized that parecoxib could effectively improve postoperative acute pain and reduce morphine consumption without serious side effects.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 106
        • National Taiwan University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients who are scheduled for uniportal video-assisted thoracoscopic surgery.
  • The American Society of Anesthesiology (ASA) score is 1 or 2.

Exclusion Criteria:

  • moderate to severe hepatic or renal insufficiency
  • active peptic ulcer or gastrointestinal bleeding
  • allergy to salicylates
  • pregnancy or lactation period
  • inflammatory bowel disease
  • congestive heart failure
  • accepted coronary artery bypass surgery
  • ischemic heart disease
  • peripheral vascular disease
  • cerebrovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parecoxib
Parecoxib 40mg will be administered to this group 15 minutes before the end of the surgery.
Drug: Parecoxib
Parecoxib 40mg will be administered to the experimental group if the patient has no contraindication.
Placebo Comparator: Placebo
2ml normal saline will be administered to this group 15 minutes before the end of the surgery.
Drug: Placebo
This is normal saline 2ml, which is equal to the volume of parecoxib solution. Placebo will be injected to placebo group 15 minutes before the end of the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative 2-hour morphine consumption
Time Frame: 2 hours
Patient-controlled analgesia will be provided to all the subjects in this study, immediately after the surgery. The investigators will record the total amounts of morphine consumption for each group.
2 hours
post-operative 24-hour morphine consumption
Time Frame: 24 hours
The investigators will record the given dosage of PCA in post-operative 24 hours.
24 hours
post-operative 48-hour morphine consumption
Time Frame: 48 hours
The investigators will record the given dosage of PCA in post-operative 48 hours.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scale
Time Frame: 2 hours/24 hours/48 hours
Resting and coughing numeric rating scale will be recorded for each group.
2 hours/24 hours/48 hours
side effects caused by analgesics
Time Frame: 48 hours
Dizziness, nausea, vomiting, voiding difficulty, respiratory depression will be recorded.
48 hours
consumption of other analgesics, besides parecoxib and morphine
Time Frame: 24 hours/48 hours
Additional salvage medication will be recorded and analyzed.
24 hours/48 hours
chronic pain prevalence
Time Frame: 3 to 6 months
Telephone interview with a questionnaire will be used to follow the outcome of all subjects.
3 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Ying-Tzu Li, MD, National Taiwan University Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

October 31, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202109025MINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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