Clinical trial NCT02617199: Epidural Anesthesia in Acute Pancreatitis
Official title: Epidural Anesthesia as an Alternative for Management in Acute Pancreatitis, a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Pancreatitis
Keywords: epidural anesthesia
pain management
microcirculation
Lead sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Sponsor class: OTHER_GOV
First posted: 2015-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with acute pancreatitis
2. Patients who agree to participate in the study

Exclusion Criteria:

1. Patients who do not agree to participate in the study
2. Patients who experience any absolute contraindication to epidural block
3. Patients with platelet counts below 80,000 mcl
4. Patients with data gastrointestinal or urinary bleeding

Primary outcomes:
measure: Hospital days stay between two groups
timeFrame: 10-15 days
Secondary outcomes:
measure: Efficacy of Epidural pain control
timeFrame: 24, 48, 72, 96,120 hours
measure: Decreased pancreatic enzymes
timeFrame: 24,48,72,96,120 hours post dose
Other outcomes:
measure: Complications associated by the epidural catheter
timeFrame: 24,48,72,96, 120 hours post epidural block
Locations:
city: México, D.F
country: Mexico
facility: Aurora Guadalupe Ruiz Sandoval
state: Distrito Federal
Study officials:
affiliation: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
name: Aurora Guadalupe Ruiz Sandoval, anesthesia
role: PRINCIPAL_INVESTIGATOR
References:
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