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To study the enhanced effect of Dexmedetomidine in Splanchnic Plexus Neurolysis when complared to other combination of drugs : A Double-Blind Randomized Controlled Trial

Enhancing Splanchnic Neurolysis With Dexmedetomidine: A Double-Blind Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077512
Enrollment
96
Registered
2024-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: C248- Malignant neoplasm of overlappingsites of biliary tract

Interventions

Intervention1: Splanchnic Neurolysis with 96% alcohol, 1% Lignocaine + Dexmedetomidine 2mcg/kg: 96% alcohol and 1% Lignocaine + Dexmedetomidine 2mcg/kg injected in T11 level via C arm guidance perine

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 years and above. 2. Diagnosis of upper gastrointestinal malignancy with abdominal pain (gastric, pancreatic, liver, or gallbladder cancers). 3. Ability to provide informed consent to participate in the study. 4. Willingness to comply with study procedures and follow-up visits. 5. Eastern Cooperative Oncology Group (ECOG) physical status classification I-III.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to splanchnic neurolysis. 2. Known allergy or hypersensitivity to Lignocaine, Dexmedetomidine, or any other study medications. 3. History of severe cardiac disease, including significant arrhythmias, heart block, or severe heart failure. 4. Coagulopathy or bleeding disorders. 5. Inability to provide informed consent or comply with study procedures. 6. Infection at needle insertion site.

Design outcomes

Primary

MeasureTime frame
Peri-procedural pain score measured in VAS scaleTimepoint: During alcohol injection and 5 minutes post-injection

Secondary

MeasureTime frame
To compare the post-procedural VAS scoresTimepoint: 1hr, 2hrs, 6hrs, 12hrs, 24hrs;To compare the opioid consumption in the first 24 hours post-procedure among different groups.Timepoint: 24 hours;To evaluate and compare the incidence of complications (during the procedure and first 24 hours post-procedure) such as hypotension, bradycardia, and burning pain from alcohol injection, across study groups.Timepoint: 24 hours;To assess patient-reported satisfaction levels with pain control and overall procedural experience.Timepoint: 24 hours;To compare pain scores and analgesic consumption at follow-upTimepoint: 1 week, 2 weeks, 1 month, 2 months

Countries

India

Contacts

Public ContactDr Saurabh Vig

All India Institute of Medical Sciences, New Delhi

saurabh377@yahoo.com9538247725

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 28, 2026