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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05009550

Enrollment

Registered

2021-08-17

Start date

2021-05-15

Completion date

2021-09-01

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Carcinoma

Keywords

Erector spinae block, Radiofrequency ablation, Hepatocellular Carcinomas, ultrasound

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.

Interventions

PROCEDUREGroup ESP

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

OTHERNon-blocked Group

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

single

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* ASA I-II patients

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzlem OZ Gergin, MD

oozgergin@erciyes.edu.tr09005332466396

Backup ContactÖzlem OZ Gergin, professor