Effect of lignocaine to decrease pain in patients undergoing RFA liver

Not yet recruiting

Conditions: Malignant neoplasm of liver, primary, unspecified as to type,

Registration Number: CTRI/2023/01/048741

Lead Sponsor: Rajiv Gandhi Cancer Institute and Research Centre

Brief Summary: Percutaneous radiofrequency ablation (PRFA) of solid tumors is a minimally invasive procedure to treat primary and/or metastatic solid tumors via thermal tissue destruction as a result of targeted thermal energy deposition and coagulative necrosis. Glissonâ€™s capsule, the fibrous covering of the liver, is innervated by branches of the lower intercostal nerves which carries sensory pathway for pain. The RFA of a subcapsular tumor causes generation of heat and gases due to burning of tumor tissue. This in turn stimulates the sensory nerve endings at the Glissonâ€™s capsule causing severe pain. This also make the ablation difficult as patient moves due to pain and may thus displace the ablation needle.

Most common method of sedation and analgesia for such procedures include: intravenous opioids, dexmedetomidine infusion, inj. ketamine and propofol. Mixture of these drugs in different doses helps the radiologist to complete the procedure with calm patient when the lesion is in liver parenchyma. For subcapsular region, the situation is different. To combat severe pain due to liver capsule irritation, high doses of these drugs are given which in turn also causes respiratory depression and obstructed airway further complicating the situation. Most commonly used drugs for such scenario are propofol and ketamine.

In view of these issues we propose a hypothesis that topicalization of Glissonian capsule with 2% lignocaine will provide adequate analgesia and reduces the dosage of anaesthetic drug.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

1.ASA Grade(I-III) 2.All patients with Subcapsular Liver lesion posted for RFA/microwave ablation.

Exclusion Criteria

1.Patients with history of M.I, Arrythmia or any other cardiac morbidity.
2.Difficult airway 3.Deranged liver function test and coagulation profile 4.Chronic alcoholic 5.History of any cognitive or psychiatric illness 6.Patients on medication for chronic pain 7.Allergy to Lignocaine 8.Patient on ventilator, poor GCS.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To achieve a visual analogue pain score of 3 during the procedure.	0 min Baseline preprocedure \| 2 min after start of procedure \| 6 min after start of procedure \| 8 min after start of procedure \| 10 min after start of procedure

Secondary Outcome Measures

Name	Time	Method
To compare visual analogue score in post procedure period	0 hour immediate post procedure
Heart Rate	0 min Baseline preprocedure
Mean arterial pressure	0 min Baseline preprocedure
Respiratory rate	0 min Baseline preprocedure
To compare the Observer assessment of alertness score	0 min Baseline preprocedure
Arterial oxygen saturation	0 min Baseline preprocedure
To compare the patient, anaesthetist and Interventional radiologist satisfaction score.	Post procedure

Trial Locations

Locations (1): Rajiv Gandhi Cancer Institute and Research Centre
🇮🇳
West, DELHI, India
Rajiv Gandhi Cancer Institute and Research Centre
🇮🇳West, DELHI, India
Dr seema shukla
Principal investigator
7579217527
drseema13@gmail.com