Back to resultsESP Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation
Primary Purpose
Hepatic Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group ESP
Non-blocked Group
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Carcinoma focused on measuring Erector spinae block, Radiofrequency ablation, Hepatocellular Carcinomas, ultrasound
Eligibility Criteria
Inclusion Criteria:
- ASA I-II patients
Exclusion Criteria:
- history of allergy to the study medication
- refused to participate
Sites / Locations
- Özlem Öz GerginRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Erector spinae plane block group (ESP)
Control Group
Arm Description
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.
This Group was received no intervention.Standard sedation method is applied to all patients.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Demographic data
Age, BMI, ASA, Duration of procedure are recorded.
Incidences of adverse effects (like nausea and vomiting)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05009550
Brief Title
ESP Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation
Official Title
Effect of Erector Spina Plain (ESP) Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Carcinoma
Keywords
Erector spinae block, Radiofrequency ablation, Hepatocellular Carcinomas, ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
single
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erector spinae plane block group (ESP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
This Group was received no intervention.Standard sedation method is applied to all patients.
Intervention Type
Procedure
Intervention Name(s)
Group ESP
Intervention Description
Single-shot ultrasound guided ESP block is performed at the T8 vertebral level before the procedure to all patients in ESP block Group
Intervention Type
Other
Intervention Name(s)
Non-blocked Group
Intervention Description
This Group is received no intervention.Patients will be sedated as standard and radiofrequency procedure will be applied.
Primary Outcome Measure Information:
Title
Numeric Pain Scale assesment
Description
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.
Time Frame
24 hours after procedure
Secondary Outcome Measure Information:
Title
Demographic data
Description
Age, BMI, ASA, Duration of procedure are recorded.
Time Frame
24 hours after procedure
Title
Incidences of adverse effects (like nausea and vomiting)
Description
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)
Time Frame
24 hours after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II patients
Exclusion Criteria:
history of allergy to the study medication
refused to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özlem OZ Gergin, MD
Phone
09005332466396
Email
oozgergin@erciyes.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Özlem OZ Gergin, professor
Phone
09005332466396
Email
oozgergin@erciyes.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozlem Oz Gergin, MD
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Özlem Öz Gergin
City
Kayseri
ZIP/Postal Code
38090
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özlem Öz Gergin, MD
Phone
09005332466396
Email
oozgergin@erciyes.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De- identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 24 months of study completion
IPD Sharing Access Criteria
Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
26321447
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.
Results Reference
result
PubMed Identifier
26266387
Citation
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.
Results Reference
result
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ESP Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation
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