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

Sponsor

TC Erciyes University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05009550

Collaborator

(none)

Enrollment

Location

Arms

3.6

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Carcinoma	Procedure: Group ESP Other: Non-blocked Group	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Masking Description:

single

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Erector spinae plane block 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. Then standard sedation method is applied to all patients.	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: Control Group This Group was received no intervention.Standard sedation method is applied to all patients.	Other: Non-blocked Group This Group is received no intervention.Patients will be sedated as standard and radiofrequency procedure will be applied.

Arm

Intervention/Treatment

Active Comparator: Erector spinae plane block 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. Then standard sedation method is applied to all patients.

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: Control Group

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

Other: Non-blocked Group

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

Outcome Measures

Primary Outcome Measures

Numeric Pain Scale assesment [24 hours after procedure]
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.

Secondary Outcome Measures

Demographic data [24 hours after procedure]
Age, BMI, ASA, Duration of procedure are recorded.
Incidences of adverse effects (like nausea and vomiting) [24 hours after procedure]
Incidences of adverse effects (like nausea and vomitting) during the 24 hours postprocedure perİod is recorded at 6 times intervals (0,2,4,6,12,24 hours)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA I-II patients

Exclusion Criteria:

history of allergy to the study medication
refused to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Özlem Öz Gergin	Kayseri		Turkey	38090

Sponsors and Collaborators

TC Erciyes University

Investigators

Principal Investigator: Ozlem Oz Gergin, MD, TC Erciyes University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Özlem ÖZ GERGİN, Principal Investigator, TC Erciyes University

ClinicalTrials.gov Identifier:

NCT05009550

Other Study ID Numbers:

2021/346

First Posted:

Aug 17, 2021

Last Update Posted:

Aug 17, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Özlem ÖZ GERGİN, Principal Investigator, TC Erciyes University

Erector spinae block

Radiofrequency ablation

Hepatocellular Carcinomas

ultrasound

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Aug 17, 2021