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

NCT05150431 | Completed Phase 4

• 1 other identifier: 202109025MINA
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Care; Chronic Post-operative Pain

Keywords

Uniportal video-assisted thoracoscopy; enhanced recovery after surgery; parecoxib; chronic post-operative pain

Outcome Measures

Primary Outcomes (3)

• 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.

  2 hours

• post-operative 24-hour morphine consumption

  The investigators will record the given dosage of PCA in post-operative 24 hours.

  24 hours

• post-operative 48-hour morphine consumption

  The investigators will record the given dosage of PCA in post-operative 48 hours.

  48 hours

Secondary Outcomes (4)

• pain scale

  2 hours/24 hours/48 hours

• side effects caused by analgesics

  48 hours

• consumption of other analgesics, besides parecoxib and morphine

  24 hours/48 hours

• chronic pain prevalence

  3 to 6 months

Study Arms (2)

Parecoxib

EXPERIMENTAL

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

Drug: Parecoxib

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Parecoxib DRUG

Parecoxib 40mg will be administered to the experimental group if the patient has no contraindication.

Parecoxib

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Cancer Center

Taipei, 106, Taiwan

Location

Related Publications (12)

• 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.

  PMID: 29302433 BACKGROUND

• Gonzalez-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.

  PMID: 23219257 BACKGROUND

• Bayman 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.

  PMID: 28248713 BACKGROUND

• Hazelrigg 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.

  PMID: 12472133 BACKGROUND

• Tong 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.

  PMID: 32765060 BACKGROUND

• Yeung 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.

  PMID: 26897642 BACKGROUND

• Turhan 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.

  PMID: 33358107 BACKGROUND

• Maher 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.

  PMID: 25009195 BACKGROUND

• Nussmeier 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.

  PMID: 16508400 BACKGROUND

• Shen 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.

  PMID: 25908099 BACKGROUND

• Huang 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.

  PMID: 32077347 BACKGROUND

• Bian 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.

  PMID: 30485685 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

parecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ying-Tzu Li, MD

  National Taiwan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: December 9, 2021
• Study Start: December 15, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 2, 2023

Record last verified: 2021-10

Locations

TW (1)