Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery

Opioid Use Clinical Trial

— EsPITHX  

Official title:

The Effects of the Epidural Catheter and Ultrason-guided Erector Spina Plan Block Catheter on Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04459923
• Other study ID #: B.30.2.ATA.0.01.00/290
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2020
• Est. completion date: May 25, 2022

Study information

• Verified date: March 2021
• Source: Ataturk University
• Contact: Kübra SELVITOPI
• Phone: +905067303513
• Email: drkubra25[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 25, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Opioid Use
• Pain, Acute
• Pain, Postoperative

Intervention

Procedure:
• ultrasound-guided erector spinae plane block catheter
for postoperative pain management ultrasound-guided erector spine plane block catheter placement
• thoracic epidural catheter
for postoperative pain management thoracic epidural catheter placement

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum	Yakutiye

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation

Karanikolas M, Swarm RA. Current trends in perioperative pain management. Anesthesiol Clin North Am. 2000 Sep;18(3):575-99. — View Citation

Ökmen K, Metin Ökmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12. — View Citation

Türk Gögüs Kalp Damar Cer Derg 2009;17(2):139-143

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	difference between average VAS scores of epidural and ESP groups	48 hour
Secondary	Total fentanyl consumption	Total fentanyl consumption.	48 hour
Secondary	VAS scores	VAS scores at rest and movement	48 hour