Epidural Anesthesia in Acute Pancreatitis

Study Overview
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Brief Summary
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Acute pancreatitis is a common urgency with a mortality rate of up to 30% , decreased blood flow in the pancreatic microcirculation. It seems to be the main cause of the pathophysiology of acute pancreatitis. Today, there have been many attempts in the management of pancreatitis but no established management seems to be ideal. The epidural block is an anesthetic technique used to provide highly peri and post-operative analgesia, also plays an important role in improving the gastrointestinal vascular perfusion (due to sympathetic blockade that this technique produces) so this anesthetic technique is proposed as an alternative to both clinical treatment as an analgesic for acute pancreatitis.

Detailed Description
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The main objective of the study is to evaluate the therapeutic effects of epidural block in patients with acute pancreatitis, comparing day hospital stay among patients receiving intravenous analgesic treatment and patients who are undergoing epidural block. It is a (prospective, comparative, longitudinal, experimental, randomized) controlled clinical trial. They include patients who are diagnosed with acute pancreatitis at the Naval General Hospital of High Specialty. Two groups were taken by random assignment.

Official Title
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Epidural Anesthesia as an Alternative for Management in Acute Pancreatitis, a Randomised Clinical Trial

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Drug: Epidural anesthesia
* Drug: intravenous analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute pancreatitis Patients who agree to participate in the study Exclusion Criteria: Patients who do not agree to participate in the study Patients who experience any absolute contraindication to epidural block Patients with platelet counts below 80,000 mcl Patients with data gastrointestinal or urinary bleeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural anesthesia<br>Epidural anesthesia placed at L1-L2 Epidural infusion of ropivacaine 0.2% + 3-4 mcg/ml fentanyl + saline 0.9% (100 ML) 3-5ml/ hr during 120 hours | Drug: Epidural anesthesia<br>* Epidural anesthesia placed at L1-L2 Epidural infusion of ropivacaine 0.2% + 3-4 mcg/ml fentanyl + saline 0.9% (100 ML) 3-5ml/ hr during 120 hours<br>* Other names: ropivacaine + fentanyl epidural;|
| Active Comparator: intravenous analgesia<br>ketorolac 1mg/kg every 8 hours or metamizol 15 mg/kg every 8 hrs and intravenous opioids (buprenorphine 3 mcg / kg or tramadol 1mg/ kg in continuos infusion | Drug: intravenous analgesia<br>* ketorolac 1mg/kg every 8 hours or metamizol 15 mg/kg every 8 hrs and intravenous opioids (buprenorphine 3 mcg / kg or tramadol 1mg/ kg in continuos infusion<br>* Other names: nonsteroidal analgesics + opioids intravenous;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital days stay between two groups | Day hospital stay were compared between the analgesic management with epidural and intravenous analgesic management | 10-15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Epidural pain control | Measured by pain scales the effectiveness of epidural use as an analgesic in acute pancreatitis | 24, 48, 72, 96,120 hours | 
| Decreased pancreatic enzymes | Recording every 24 hours of laboratory values, these values decreased observing and evaluating the clinical status of the patient | 24,48,72,96,120 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural anesthesia, pain management, microcirculation