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Epidural Anesthesia in Acute Pancreatitis

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ClinicalTrials.gov Identifier: NCT02617199
Recruitment Status : Unknown
Verified January 2016 by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Recruitment status was:  Recruiting
First Posted : November 30, 2015
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Drug: Epidural anesthesia Drug: intravenous analgesia Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epidural Anesthesia as an Alternative for Management in Acute Pancreatitis, a Randomised Clinical Trial
Study Start Date : November 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: nonsteroidal analgesics + opioids intravenous




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. Complications associated by the epidural catheter [ Time Frame: 24,48,72,96, 120 hours post epidural block ]
    Complications by epidural catheter placement



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617199


Contacts
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Contact: Aurora Guadalupe Ruiz Sandoval, Anesthesia (045) 5591852731 rusa2910@hotmail.com
Contact: Luis Gerardo Motta Amezquita, Anesthesia (045) 5529621028 rusa2910@hotmail.com

Locations
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Mexico
Aurora Guadalupe Ruiz Sandoval Recruiting
México, D.F, Distrito Federal, Mexico, 04260
Contact: Aurora Guadalupe Ruiz Sandoval, Anesthesia    (045) 5591852732    rusa2910@hotmail.com   
Contact: Gerardo Motta Amezquita, Anesthesia    (045) 5529621028    rusa2910@hotmail.com   
Sponsors and Collaborators
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Investigators
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Principal Investigator: Aurora Guadalupe Ruiz Sandoval, anesthesia Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Publications of Results:
Simón Hew. Acute pancreatitis: an intensive care perspective. Anteshesia and intensive care medicine. 2012; 171-175
Manuel Díaz de León. Diagnóstico y tratamiento de la pancreatitis aguda grave. Medicina crítica y terapia intensiva. 2003 (17):104-10
J. Gil Sebrián. Analgesia y sedación en la pancreatitis aguda. Med intensiva 2003;27(2):116-28

Other Publications:
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Responsible Party: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier: NCT02617199     History of Changes
Other Study ID Numbers: HGNAE-08
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Keywords provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:
epidural anesthesia
pain management
microcirculation
Additional relevant MeSH terms:
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Ropivacaine
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Fentanyl
Analgesics, Opioid
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Local