Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery

Not Applicable

• Conditions: Pain, Acute; Opioid Use

• Registration Number: NCT04459923
• Lead Sponsor: Ataturk University

Brief Summary

Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary, mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy can be performed with smaller incisions using video support. While being less invasive in comparison to open surgery options, thoracoscopic surgery may damage the intercostal nerve and damages muscles. Also it provokes soft tissue edema at the incision area. Therefore, pain can be more intense than expected after thoracoscopic procedures. Post-operation pain is not just an acute problem; 20% of the patients develop chronic incision pain after a thoracic surgery.

particiants hypothesis is that continue ESP block catheter application is non-inferior than epidural catheter application in the first post-operative 48 hours regarding post-operative pain relief. The purpose of this study is to invertigate the effects of TEA and ESPB on post-operative pain in patients undergoing VATS.

Detailed Description

Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary, mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy can be performed with smaller incisions using video support. Literature shows that resections performed with VATS result in shorter hospital stay, lower complication rates, lower mortality rates and similar survivability rates in comparison to thoracotomy. While being less invasive in comparison to open surgery options, thoracoscopic surgery may damage the intercostal nerve and damages muscles. Also it provokes soft tissue edema at the incision area. Therefore, pain can be more intense than expected after thoracoscopic procedures. Post-operation pain is not just an acute problem; 20% of the patients develop chronic incision pain after a thoracic surgery.

Post-operative pain is a type of acute pain which starts with surgical procedure and ends with tissue recovery. Eliminating this pain is one of the important purposes of anaesthesia. Post-operative analgesia methods may prevent the patient from feeling pain, but there has been no consensus regarding pain management, and generally a multi-modal approach is the most preferable approach. While various methods are used for post-operation analgesia, studies to increase patient satisfaction are still ongoing.

Thoracic epidural analgesia (TEA) and paravertebral block are gold standard of analgesia methods for thoracoscopy operations, and these are widely used for VATS procedures. An epidural application generally performed at the level of T5-7 intervertebral space for thoracic surgery. While intra-operative analgesia is also provided using by an epidural catheter, it is also the first preference in post-operative analgesia management. It can be applied by continuous infusion of local anesthetic, or bolus dosages with 4-6 hours intervals.

Erector spina plane block (ESPB) is a type of block applied by injection of a local anaesthetic into the interfacial plane under the erector spina muscle, and it is defined as an analgesic method for thoracic neuropathic pain in 2016. The dermatome area it covers varies according to the level of application. It can be applied under USG guidance and its application may be considered less invasive in comparison to thoracic epidural. Due to its easier application it can prove to be a more popular approach in the future. In thoracic surgeries, single-shut at the T5-6 level can be used or multiple shuts at multiple levels can be applied or continue analgesia can be applied by catheter

* There has been no randomised controlled study comparing epidural versus erector spinae plane block in the literature.

particiants hypothesis is that continue ESP block catheter application is non-inferior than epidural catheter application in the first post-operative 48 hours regarding post-operative pain relief. The purpose of this study is to invertigate the effects of TEA and ESPB on post-operative pain in patients undergoing VATS.

Study Timeline

• Study Start: 2020-06-20
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-12
• Primary Completion: 2021-12-30
• Study Completion: 2022-05-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• VATS surgery patients
• ASA I-III group
• without any chronic pain or anychronic analgesic usage history
• volunteer to participate in the study

Exclusion Criteria

• Patients of ASA IV and above
• patients with a BMI > 30
• patients receiving anticoagulant treatments
• patients having previous neurologic sequellae history
• patients having previous thoracoctomy history on the same side
• patients having any allergy against any of the drugs used in the study (paracetamol, non-steroid analgesics and opioids) will be excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS	48 hour	difference between average VAS scores of epidural and ESP groups

Secondary Outcome Measures

Name	Time	Method
Total fentanyl consumption	48 hour	Total fentanyl consumption.
VAS scores	48 hour	VAS scores at rest and movement

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Yakutiye, Turkey