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

Primary Purpose

Perioperative Care, Chronic Post-operative Pain

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Parecoxib
Placebo
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative Care focused on measuring Uniportal video-assisted thoracoscopy, enhanced recovery after surgery, parecoxib, chronic post-operative pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Parecoxib

Placebo

Arm Description

Parecoxib 40mg will be administered to this group 15 minutes before the end of the surgery.

2ml normal saline will be administered to this group 15 minutes before the end of the surgery.

Outcomes

Primary Outcome Measures

post-operative 2-hour morphine consumption
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.
post-operative 24-hour morphine consumption
The investigators will record the given dosage of PCA in post-operative 24 hours.
post-operative 48-hour morphine consumption
The investigators will record the given dosage of PCA in post-operative 48 hours.

Secondary Outcome Measures

pain scale
Resting and coughing numeric rating scale will be recorded for each group.
side effects caused by analgesics
Dizziness, nausea, vomiting, voiding difficulty, respiratory depression will be recorded.
consumption of other analgesics, besides parecoxib and morphine
Additional salvage medication will be recorded and analyzed.
chronic pain prevalence
Telephone interview with a questionnaire will be used to follow the outcome of all subjects.

Full Information

First Posted
October 31, 2021
Last Updated
August 1, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05150431
Brief Title
Optimized Acute Pain Control With Parecoxib in Uniportal Video-assisted Thoracoscopic Surgery.
Official Title
Perioperative Pain-control With Parecoxib in Uniportal Video-assisted Thoracoscopic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Care, Chronic Post-operative Pain
Keywords
Uniportal video-assisted thoracoscopy, enhanced recovery after surgery, parecoxib, chronic post-operative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parecoxib
Arm Type
Experimental
Arm Description
Parecoxib 40mg will be administered to this group 15 minutes before the end of the surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2ml normal saline will be administered to this group 15 minutes before the end of the surgery.
Intervention Type
Drug
Intervention Name(s)
Parecoxib
Intervention Description
Parecoxib 40mg will be administered to the experimental group if the patient has no contraindication.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
post-operative 2-hour morphine consumption
Description
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.
Time Frame
2 hours
Title
post-operative 24-hour morphine consumption
Description
The investigators will record the given dosage of PCA in post-operative 24 hours.
Time Frame
24 hours
Title
post-operative 48-hour morphine consumption
Description
The investigators will record the given dosage of PCA in post-operative 48 hours.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
pain scale
Description
Resting and coughing numeric rating scale will be recorded for each group.
Time Frame
2 hours/24 hours/48 hours
Title
side effects caused by analgesics
Description
Dizziness, nausea, vomiting, voiding difficulty, respiratory depression will be recorded.
Time Frame
48 hours
Title
consumption of other analgesics, besides parecoxib and morphine
Description
Additional salvage medication will be recorded and analyzed.
Time Frame
24 hours/48 hours
Title
chronic pain prevalence
Description
Telephone interview with a questionnaire will be used to follow the outcome of all subjects.
Time Frame
3 to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Tzu Li, MD
Organizational Affiliation
National Taiwan University Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Cancer Center
City
Taipei
ZIP/Postal Code
106
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29302433
Citation
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Citation
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PubMed Identifier
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Citation
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Optimized Acute Pain Control With Parecoxib in Uniportal Video-assisted Thoracoscopic Surgery.

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