Epidural Anesthesia in Acute Pancreatitis

Phase 2

• Conditions: Acute Pancreatitis
• Interventions: Drug: Epidural anesthesia; Drug: intravenous analgesia

• Registration Number: NCT02617199
• Lead Sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-14
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-11-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-11
• Primary Completion: 2016-12
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural anesthesia	Epidural anesthesia	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
intravenous analgesia	intravenous analgesia	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

Primary Outcome Measures

Name	Time	Method
Hospital days stay between two groups	10-15 days	Day hospital stay were compared between the analgesic management with epidural and intravenous analgesic management

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aurora Guadalupe Ruiz Sandoval; 🇲🇽 México, D.F, Distrito Federal, Mexico