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

Phase 4

Completed

• Conditions: Perioperative Care; Chronic Post-operative Pain
• Interventions: Drug: Placebo; Drug: Parecoxib

• Registration Number: NCT05150431
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-31
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-09
• Study Start: 2021-12-15
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2ml normal saline will be administered to this group 15 minutes before the end of the surgery.
Parecoxib	Parecoxib	Parecoxib 40mg will be administered to this group 15 minutes before the end of the surgery.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Cancer Center; 🇨🇳 Taipei, Taiwan