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NCT Number: NCT04241887

Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors

Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the periooperative setting. In order to facilitate tumor access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious.

This study aims to assess the impact of a single shot thoracic paravertebral block (TPVB) on a patient's haemodynamic stability, patient's and operator's comfort and satisfaction during the operation and analgesia in the post-operative period.

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Key information

Conditions

Liver Tumor Adenocarcinoma Agnosia Behavior Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Health Behavior Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital

Olsztyn, Warmian-Masurian Voivodeship, 11-041, Poland

About this study

High temperatures used during the percutaneus radiofrequency ablation (PRFA) of liver tumors can cause acute pain in the perioperative setting. In order to facilitate tumor exposure and access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. It is mandatory to provide an adequate acute postoperative pain control for our patients.

This prospective randomized, single center study was approved by the Bioethics Committee at the University of Warmia and Mazury in Olsztyn, (Poland) under the resolution No. 46/2017.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with primary liver tumor (HCC)
  • patient scheduled for an elective surgery
  • tumor diameter) <5 cm two tumors <3cm
  • Age >18 years
  • Physical State 1,2 or 3 of the American Society of Anesthesiology (ASA)

Exclusion criteria

  • ASA IV and V
  • Thrombocytopenia (<40x10 ^ 9 / L)
  • Severe cirrhosis (Child-Pugh C classification)
  • History of psychiatric/cognitive disease
  • Patients who do not give informed consent
  • Patients with contraindications or history of hypersensitivity to local anaesthesia drugs
  • History of chronic pain, chronic opioid use (> 3 months)

Treatment and study plan

thoracic paravertebral blockade

Procedure

Anesthesia was performed under the ultrasound guidance: the Th8 spinous process was identified, then a probe was moved lateral to medial until two adjacent transverse processes and the pleura were visible. After anaesthetising the skin with 2ml of 1% lignocaine (Lignocainum hydrochlorici, WZF 1%), the Touhy needle 22G (Smith Medical)was introduced under the real time guidance. Once in the paravertebral space, 20ml of 0,25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa Warsaw SA) was injected with an end point of a characteristic pleural displacement.

local anaesthesia

Procedure

Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.

Primary outcomes

  1. Effectiveness of PVB on pain intensity

    Time frame: NRS during the procedure and 0,1,3,6,24 hours post surgery

    The level of pain will be assessed in all groups (PVB and BB) basing on the NRS scale (NRS 0- no pain, NRS 10 - the worst pain imaginable) Self reported pain intensity in 5 time points based on the numerical rating scale NRS (where 0 is no pain, 10 is the strongest pain).

    comparison of analgesic drug use in both groups

  2. Effectiveness of PVB on pain intensity

    Time frame: 0,1,3,6,24 hours post surgery

    The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption

Secondary outcomes

  1. Patients' satisfaction

    Time frame: 24 hours post surgery

    Patients' satisfaction will be assessed in all groups (PVB and BB) basing on a survey

  2. Surgeon's satisfaction

    Time frame: 0 h post surgery (immediately after surgery)

    Surgeon's satisfaction will be assessed in all groups (PVB and BB) basing on a survey (where 0 is no satisfaction, 10-maximal satisfaction)

Sponsors and collaborators

Lead sponsor

University of Warmia and Mazury

Other

Registry information

Official study title

Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for Percutaneous Radiofrequency Ablation of Liver Tumors

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 27, 2020
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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