ESP Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation

Hepatic Carcinoma Clinical Trial

Official title:

Effect of Erector Spina Plain (ESP) Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009550
• Other study ID #: 2021/346
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: August 2021
• Source: TC Erciyes University
• Contact: Özlem OZ Gergin, MD
• Phone: 09005332466396
• Email: oozgergin[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the ability of Erector spina Plane Block decrease postoperative pain and analgesia requirements in patients undergoing percutaneous Radiofrequency ablation of Hepatocellular Carcinomas.

Description:

Erector spina Plane Block is performed with guided ultrasound at T8 transverse process level lead to adequate intraprocedural and postoperative analgesia, in percutaneous Radiofrequency ablation of Hepatocellular Carcinomas.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA I-II patients

Exclusion Criteria:

• history of allergy to the study medication
• refused to participate

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatic Carcinoma

Intervention

Procedure:
• Group ESP
Single-shot ultrasound guided ESP block is performed at the T8 vertebral level before the procedure to all patients in ESP block Group

Other:
• Non-blocked Group
This Group is received no intervention.Patients will be sedated as standard and radiofrequency procedure will be applied.

Locations

Country	Name	City	State
Turkey	Özlem Öz Gergin	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Joung KW, Choi SS, Jang DM, Kong YG, Lee HM, Shim JH, Won HJ, Shin YM, Kim PN, Song MH. Comparative Effects of Dexmedetomidine and Propofol on US-Guided Radiofrequency Ablation of Hepatic Neoplasm Under Monitored Anesthesia Care: A Randomized Controlled S — View Citation

Wells SA, Hinshaw JL, Lubner MG, Ziemlewicz TJ, Brace CL, Lee FT Jr. Liver Ablation: Best Practice. Radiol Clin North Am. 2015 Sep;53(5):933-71. doi: 10.1016/j.rcl.2015.05.012. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Scale assesment	A research assistant, blinded to the group allocation, interviewed patients and collected data at 6 times intervals (0.,2.,4.,6.,12 and 24 hours) in the 24 hours postprocedure. Patients will be asked to rate their pain using Numeric Pain Scale, where 0=no pain and 10=worst pain possible.	24 hours after procedure
Secondary	Demographic data	Age, BMI, ASA, Duration of procedure are recorded.	24 hours after procedure
Secondary	Incidences of adverse effects (like nausea and vomiting)	Incidences of adverse effects (like nausea and vomitting) during the 24 hours postprocedure perIod is recorded at 6 times intervals (0,2,4,6,12,24 hours)	24 hours after procedure