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

NCT05009550 | Unknown

• 1 other identifier: 2021/346
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Carcinoma

Keywords

Erector spinae block; Radiofrequency ablation; Hepatocellular Carcinomas; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Demographic data

  24 hours after procedure

• Incidences of adverse effects (like nausea and vomiting)

  24 hours after procedure

Study Arms (2)

Erector spinae plane block group (ESP)

ACTIVE COMPARATOR

Single-shot ultrasound guided ESP block is performed at the T8 vertebral level before the procedure to all patients in ESP block Group. Then standard sedation method is applied to all patients.

Procedure: Group ESP

Control Group

OTHER

This Group was received no intervention.Standard sedation method is applied to all patients.

Other: Non-blocked Group

Interventions

Group ESP PROCEDURE

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

Erector spinae plane block group (ESP)

Non-blocked Group OTHER

This Group is received no intervention.Patients will be sedated as standard and radiofrequency procedure will be applied.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Özlem Öz Gergin

Kayseri, 38090, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 26321447 RESULT

• 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 Study. Medicine (Baltimore). 2015 Aug;94(32):e1349. doi: 10.1097/MD.0000000000001349.

  PMID: 26266387 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ozlem Oz Gergin, MD

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özlem OZ Gergin, MD

CONTACT

09005332466396; oozgergin@erciyes.edu.tr

Özlem OZ Gergin, professor

CONTACT

09005332466396; oozgergin@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 17, 2021
• Study Start: May 15, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 24 months of study completion
• Access Criteria: Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.

Locations

TU (1)