Epidural Anesthesia in Acute Pancreatitis

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Acute Pancreatitis

Treatments: Drug: intravenous analgesia; Drug: Epidural anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02617199

HGNAE-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Epidural anesthesia

Experimental group

Description:

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

Treatment:

Drug: Epidural anesthesia

intravenous analgesia

Active Comparator group

Description:

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

Treatment:

Drug: intravenous analgesia