Epidural Anesthesia in Acute Pancreatitis

January 7, 2016 updated by: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aurora Guadalupe Ruiz Sandoval, Anesthesia
  • Phone Number: (045) 5591852731
  • Email: rusa2910@hotmail.com

Study Contact Backup

  • Name: Luis Gerardo Motta Amezquita, Anesthesia
  • Phone Number: (045) 5529621028
  • Email: rusa2910@hotmail.com

Study Locations

  • Mexico
    • Distrito Federal
      • México, D.F, Distrito Federal, Mexico, 04260
        • Recruiting
        • Aurora Guadalupe Ruiz Sandoval
        • Contact:
          • Aurora Guadalupe Ruiz Sandoval, Anesthesia
          • Phone Number: (045) 5591852732
          • Email: rusa2910@hotmail.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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
Other Names:
  • ropivacaine + fentanyl epidural
Active Comparator: 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
Drug: 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
Other Names:
  • nonsteroidal analgesics + opioids intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital days stay between two groups
Time Frame: 10-15 days
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
Time Frame: 24, 48, 72, 96,120 hours
Measured by pain scales the effectiveness of epidural use as an analgesic in acute pancreatitis
24, 48, 72, 96,120 hours
Decreased pancreatic enzymes
Time Frame: 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
24,48,72,96,120 hours post dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications associated by the epidural catheter
Time Frame: 24,48,72,96, 120 hours post epidural block
Complications by epidural catheter placement
24,48,72,96, 120 hours post epidural block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Investigators

  • Principal Investigator: Aurora Guadalupe Ruiz Sandoval, anesthesia, Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

November 14, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGNAE-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Pancreatitis

Clinical Trials on Epidural anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe