Perioperative CarePhase 4NCT05150431
Optimized Acute Pain Control With Parecoxib in Uniportal Video-assisted Thoracoscopic Surgery.
A Phase 4 study testing Parecoxib in people with Perioperative Care and Chronic Post-operative Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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%. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Perioperative Care, Chronic Post-operative Pain
- What is being tested?
- Parecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2021to 1 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are scheduled for uniportal video-assisted thoracoscopic surgery.
- The American Society of Anesthesiology (ASA) score is 1 or 2.
Who cannot join
- 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
Show all 10Show fewer
- accepted coronary artery bypass surgery
- ischemic heart disease
- peripheral vascular disease
- cerebrovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Perioperative Care, Chronic Post-operative Pain
- Being tested
- Parecoxib, Placebo
- Keywords
- Uniportal video-assisted thoracoscopy, enhanced recovery after surgery, parecoxib, chronic post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
Parecoxib 40mg will be administered to the experimental group if the patient has no contraindication.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Parecoxib | Experimental | Parecoxib 40mg will be administered to this group 15 minutes before the end of the surgery. Receives: Drug: Parecoxib |
| Placebo | Placebo comparator | 2ml normal saline will be administered to this group 15 minutes before the end of the surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
post-operative 24-hour morphine consumption
The investigators will record the given dosage of PCA in post-operative 24 hours.
Measured: 24 hours
post-operative 48-hour morphine consumption
The investigators will record the given dosage of PCA in post-operative 48 hours.
Measured: 48 hours
Secondary outcomes (4)
pain scale
Resting and coughing numeric rating scale will be recorded for each group.
Measured: 2 hours/24 hours/48 hours
side effects caused by analgesics
Dizziness, nausea, vomiting, voiding difficulty, respiratory depression will be recorded.
Measured: 48 hours
consumption of other analgesics, besides parecoxib and morphine
Additional salvage medication will be recorded and analyzed.
Measured: 24 hours/48 hours
chronic pain prevalence
Telephone interview with a questionnaire will be used to follow the outcome of all subjects.
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start15 Dec 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Perioperative CareStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying-Tzu Li, MD, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150431
- Sponsor's protocol ID
- 202109025MINA
- Status last verified
- Oct 2021
- First submitted
- 31 Oct 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mineo TC, Ambrogi V. A glance at the history of uniportal video-assisted thoracic surgery. J Vis Surg. 2017 Nov 7;3:157. doi: 10.21037/jovs.2017.10.11. eCollection 2017.
PubMed 29302433Gonzalez-Rivas D, Paradela M, Fernandez R, Delgado M, Fieira E, Mendez L, Velasco C, de la Torre M. Uniportal video-assisted thoracoscopic lobectomy: two years of experience. Ann Thorac Surg. 2013 Feb;95(2):426-32. doi: 10.1016/j.athoracsur.2012.10.070. Epub 2012 Dec 5.
PubMed 23219257Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576.
PubMed 28248713Hazelrigg SR, Cetindag IB, Fullerton J. Acute and chronic pain syndromes after thoracic surgery. Surg Clin North Am. 2002 Aug;82(4):849-65. doi: 10.1016/s0039-6109(02)00031-2.
PubMed 12472133Tong Y, Wei P, Wang S, Sun Q, Cui Y, Ning N, Chen S, He X. Characteristics of Postoperative Pain After VATS and Pain-Related Factors: The Experience in National Cancer Center of China. J Pain Res. 2020 Jul 21;13:1861-1867. doi: 10.2147/JPR.S249134. eCollection 2020.
PubMed 32765060Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
PubMed 26897642Turhan O, Sivrikoz N, Sungur Z, Duman S, Ozkan B, Senturk M. Thoracic Paravertebral Block Achieves Better Pain Control Than Erector Spinae Plane Block and Intercostal Nerve Block in Thoracoscopic Surgery: A Randomized Study. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):2920-2927. doi: 10.1053/j.jvca.2020.11.034. Epub 2020 Nov 20.
PubMed 33358107Maher DP, Wong W, White PF, McKenna R Jr, Rosner H, Shamloo B, Louy C, Wender R, Yumul R, Zhang V. Association of increased postoperative opioid administration with non-small-cell lung cancer recurrence: a retrospective analysis. Br J Anaesth. 2014 Jul;113 Suppl 1:i88-94. doi: 10.1093/bja/aeu192. Epub 2014 Jul 9.
PubMed 25009195Nussmeier NA, Whelton AA, Brown MT, Joshi GP, Langford RM, Singla NK, Boye ME, Verburg KM. Safety and efficacy of the cyclooxygenase-2 inhibitors parecoxib and valdecoxib after noncardiac surgery. Anesthesiology. 2006 Mar;104(3):518-26. doi: 10.1097/00000542-200603000-00020.
PubMed 16508400Shen H, Chen Y, Lu KZ, Chen J. Parecoxib for the prevention of shivering after general anesthesia. J Surg Res. 2015 Jul;197(1):139-44. doi: 10.1016/j.jss.2015.03.011. Epub 2015 Mar 28.
PubMed 25908099Huang JM, Lv ZT, Zhang B, Jiang WX, Nie MB. Intravenous parecoxib for early postoperative cognitive dysfunction in elderly patients: evidence from a meta-analysis. Expert Rev Clin Pharmacol. 2020 Apr;13(4):451-460. doi: 10.1080/17512433.2020.1732815. Epub 2020 Feb 28.
PubMed 32077347Bian YY, Wang LC, Qian WW, Lin J, Jin J, Peng HM, Weng XS. Role of Parecoxib Sodium in the Multimodal Analgesia after Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial. Orthop Surg. 2018 Nov;10(4):321-327. doi: 10.1111/os.12410.
PubMed 30485685
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pain-control With Parecoxib in Uniportal Video-assisted Thoracoscopic Surgery.
- ClinicalTrials.gov ID
- NCT05150431
- Acronym / sponsor ID
- 202109025MINA
- Conditions
- Perioperative Care, Chronic Post-operative Pain
- Keywords
- Uniportal video-assisted thoracoscopy, enhanced recovery after surgery, parecoxib, chronic post-operative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parecoxib | Experimental | Drug: ParecoxibParecoxib 40mg will be administered to this group 15 minutes before the end of the surgery. |
| Placebo | Placebo comparator | Drug: Placebo2ml normal saline will be administered to this group 15 minutes before the end of the surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who are scheduled for uniportal video-assisted thoracoscopic surgery.
- The American Society of Anesthesiology (ASA) score is 1 or 2.
Key exclusion criteria (10 listed)
- moderate to severe hepatic or renal insufficiency
- active peptic ulcer or gastrointestinal bleeding
- allergy to salicylates
- pregnancy or lactation period
- inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParecoxibParecoxib 40mg will be administered to the experimental group if the patient has no contraindication. | Drug | Parecoxib |
| PlaceboThis 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. | Drug | Placebo |
Primary outcome
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.
post-operative 24-hour morphine consumption
Time frame: 24 hours
The investigators will record the given dosage of PCA in post-operative 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.
4 secondary outcomes
pain scale
Time frame: 2 hours/24 hours/48 hours
side effects caused by analgesics
Time frame: 48 hours
consumption of other analgesics, besides parecoxib and morphine
Time frame: 24 hours/48 hours
chronic pain prevalence
Time frame: 3 to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Background: PubMed 29302433Mineo TC, Ambrogi V. A glance at the history of uniportal video-assisted thoracic surgery. J Vis Surg. 2017 Nov 7;3:157. doi: 10.21037/jovs.2017.10.11. eCollection 2017.
- Background: PubMed 23219257Gonzalez-Rivas D, Paradela M, Fernandez R, Delgado M, Fieira E, Mendez L, Velasco C, de la Torre M. Uniportal video-assisted thoracoscopic lobectomy: two years of experience. Ann Thorac Surg. 2013 Feb;95(2):426-32. doi: 10.1016/j.athoracsur.2012.10.070. Epub 2012 Dec 5.
- Background: PubMed 28248713Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576.
- Background: PubMed 12472133Hazelrigg SR, Cetindag IB, Fullerton J. Acute and chronic pain syndromes after thoracic surgery. Surg Clin North Am. 2002 Aug;82(4):849-65. doi: 10.1016/s0039-6109(02)00031-2.
- Background: PubMed 32765060Tong Y, Wei P, Wang S, Sun Q, Cui Y, Ning N, Chen S, He X. Characteristics of Postoperative Pain After VATS and Pain-Related Factors: The Experience in National Cancer Center of China. J Pain Res. 2020 Jul 21;13:1861-1867. doi: 10.2147/JPR.S249134. eCollection 2020.
- Background: PubMed 26897642Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
- Background: PubMed 33358107Turhan O, Sivrikoz N, Sungur Z, Duman S, Ozkan B, Senturk M. Thoracic Paravertebral Block Achieves Better Pain Control Than Erector Spinae Plane Block and Intercostal Nerve Block in Thoracoscopic Surgery: A Randomized Study. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):2920-2927. doi: 10.1053/j.jvca.2020.11.034. Epub 2020 Nov 20.
- Background: PubMed 25009195Maher DP, Wong W, White PF, McKenna R Jr, Rosner H, Shamloo B, Louy C, Wender R, Yumul R, Zhang V. Association of increased postoperative opioid administration with non-small-cell lung cancer recurrence: a retrospective analysis. Br J Anaesth. 2014 Jul;113 Suppl 1:i88-94. doi: 10.1093/bja/aeu192. Epub 2014 Jul 9.
- Background: PubMed 16508400Nussmeier NA, Whelton AA, Brown MT, Joshi GP, Langford RM, Singla NK, Boye ME, Verburg KM. Safety and efficacy of the cyclooxygenase-2 inhibitors parecoxib and valdecoxib after noncardiac surgery. Anesthesiology. 2006 Mar;104(3):518-26. doi: 10.1097/00000542-200603000-00020.
- Background: PubMed 25908099Shen H, Chen Y, Lu KZ, Chen J. Parecoxib for the prevention of shivering after general anesthesia. J Surg Res. 2015 Jul;197(1):139-44. doi: 10.1016/j.jss.2015.03.011. Epub 2015 Mar 28.
- Background: PubMed 32077347Huang JM, Lv ZT, Zhang B, Jiang WX, Nie MB. Intravenous parecoxib for early postoperative cognitive dysfunction in elderly patients: evidence from a meta-analysis. Expert Rev Clin Pharmacol. 2020 Apr;13(4):451-460. doi: 10.1080/17512433.2020.1732815. Epub 2020 Feb 28.
- Background: PubMed 30485685Bian YY, Wang LC, Qian WW, Lin J, Jin J, Peng HM, Weng XS. Role of Parecoxib Sodium in the Multimodal Analgesia after Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial. Orthop Surg. 2018 Nov;10(4):321-327. doi: 10.1111/os.12410.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Tzu Li, MD study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Parecoxib in people with Perioperative Care and Chronic Post-operative Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative 2-hour morphine consumption (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150431, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.