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Chronic Calcific Pancreatitis Study

Comparison of analgesic effectiveness of ultrasound-guided Erector Spinae Plane Intra Thecal Opioid (ESPITO) analgesia with Thoracic Epidural Analgesia (TEA) in patients undergoing open upper abdominal surgery for chronic calcific pancreatitis (CCP): A two-center assessor blinded randomized controlled non-inferiority trial - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058807
Enrollment
72
Registered
2023-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Thoracic Epidural Analgesia: The procedure will be performed under aseptic precautions in the operation theatre complex at the participating hospitals. After establishing an intravenous

Sponsors

Sri Madhusudan Sai Institute of Medical Sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients diagnosed with chronic calcific pancreatitis with intractable pain scheduled for elective open pancreatic surgery who are willing to consent

Exclusion criteria

Exclusion criteria: Participants unwilling to provide consent Patients undergoing emergency pancreatic surgery Participants with known history of drug allergy to bupivacaine Participants who have received a coeliac plexus block

Design outcomes

Primary

MeasureTime frame
Mean Numerical Rating Scale (NRS) pain scores on coughingTimepoint: Mean Numerical Rating Scale (NRS) pain scores on coughing

Secondary

MeasureTime frame
Numerical Rating Scale on coughingTimepoint: 1, 6, 16, 40, 48, 64 and 72 hours after surgery;Mean Numerical Rating Scale (NRS) pain scores at restTimepoint: 1, 6, 16, 24, 40, 48, 64 and 72 hours after surgery;Patient satisfaction with pain managementTimepoint: 72 hours after surgery;Tramadol consumptionTimepoint: 72 hours after surgery;Complication with pain management techniqueTimepoint: 72 hours after surgery;Complication with surgeryTimepoint: 30 days after surgery;Total post operative Intravenous fluids usedTimepoint: 72 hours after surgery

Countries

India

Contacts

Public ContactDr Niraj Gopinath

Sri Madhusudan Sai Institute of Medical Sciences and Research

niraj.gopinath@smsimsr.org9036119279

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026