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To evaluate the ability of Erector spina Plane Block decrease postoperative pain and analgesia requirements in patients undergoing percutaneous Radiofrequency ablation of Hepatocellular Carcinomas.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Other | This Group was received no intervention.Standard sedation method is applied to all patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data | Age, BMI, ASA, Duration of procedure are recorded. | 24 hours after procedure |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Özlem OZ Gergin, MD | Contact | 09005332466396 | oozgergin@erciyes.edu.tr | |
| Özlem OZ Gergin, professor | Contact | 09005332466396 | oozgergin@erciyes.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Ozlem Oz Gergin, MD | TC Erciyes University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Özlem Öz Gergin | Recruiting | Kayseri | 38090 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26321447 | Result | 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. | |
| 26266387 | 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. |
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De- identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 24 months of study completion
Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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single
| Non-blocked Group | Other | This Group is received no intervention.Patients will be sedated as standard and radiofrequency procedure will be applied. |
|
| 24 hours after procedure |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |