Rhomboid Intercostal and Subserratus / Paravertebral Block

Anesthesia Clinical Trial

Official title:

"Comparison of Rhomboid Intercostal and Subserratus Plane Blocks Applied for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery With Thoracic Paravertebral Block"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06253741
• Other study ID #: 2022-17/23
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Uludag University
• Contact: SEDA CANSABUNCU
• Phone: +9002242940000
• Email: sedacansabuncu[@]uludag.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative pain is a significant concern following video-assisted thoracoscopic surgery (VATS). Pain after thoracic surgery not only causes a strong stress reaction and adverse emotional experience but also affects postoperative rehabilitation. Hence, different analgesia techniques, including local anesthetic infiltration, intercostal nerve block, paravertebral block, and thoracic epidural anesthesia, have been described to attenuate the intensity of acute postoperative painparavertebral block (PVB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after video-assisted thoracoscopic surgery (VATS). This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of ultra- sound-guided PVB and RISS block after video-assisted thoracoscopic surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Planned for VATS

• American Society of Anesthesiologists (ASA) class I and II

• Patients aged between 18-80

Exclusion Criteria:

• Contraindications to local anesthetic allergy or bupivacaine

• Known or suspected coagulopathy

• Injection site infection

• History of thoracic surgery

• Severe neurological or psychiatric disorder

• Severe cardiovascular disease

• Liver failure

• Renal failure (glomerular filtration rate <15 ml/min/1.73 m2)

• Chronic opioid use

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Thoracic

Intervention

Procedure:
• PARAVERTEBRAL BLOCK
Hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes
• RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK
Hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes.
• PLACEBO
Hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes.

Locations

Country	Name	City	State
Turkey	Bursa Uludag University	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS scores	The primary outcome of this study was to compare the analgesia of paravertebral block versus rhomboid intercostal and subserratus plane block in VATS surgery.	up to 24 hours
Secondary	morphine consumption	The secondary outcome measure in this study was 24-hour morphine consumption.	up to 24 hours
Secondary	first analgesia requirement	Secondary outcome measures included time to first request for morphine	up to 24 hours
Secondary	Side effects	Side effects associated with morphine consumption	up to 24 hours