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Epidural Anesthesia in Acute Pancreatitis

Primary Purpose

Acute Pancreatitis

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Epidural anesthesia
intravenous analgesia
Sponsored by
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring epidural anesthesia, pain management, microcirculation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aurora Guadalupe Ruiz SandovalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Epidural anesthesia

intravenous analgesia

Arm 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

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

Outcomes

Primary Outcome Measures

Hospital days stay between two groups
Day hospital stay were compared between the analgesic management with epidural and intravenous analgesic management

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2015
Last Updated
January 7, 2016
Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
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1. Study Identification

Unique Protocol Identification Number
NCT02617199
Brief Title
Epidural Anesthesia in Acute Pancreatitis
Official Title
Epidural Anesthesia as an Alternative for Management in Acute Pancreatitis, a Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
epidural anesthesia, pain management, microcirculation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural anesthesia
Arm Type
Experimental
Arm 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
Arm Title
intravenous analgesia
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Epidural anesthesia
Other Intervention Name(s)
ropivacaine + fentanyl epidural
Intervention 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
Intervention Type
Drug
Intervention Name(s)
intravenous analgesia
Other Intervention Name(s)
nonsteroidal analgesics + opioids intravenous
Intervention 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
Primary Outcome Measure Information:
Title
Hospital days stay between two groups
Description
Day hospital stay were compared between the analgesic management with epidural and intravenous analgesic management
Time Frame
10-15 days
Secondary Outcome Measure Information:
Title
Efficacy of Epidural pain control
Description
Measured by pain scales the effectiveness of epidural use as an analgesic in acute pancreatitis
Time Frame
24, 48, 72, 96,120 hours
Title
Decreased pancreatic enzymes
Description
Recording every 24 hours of laboratory values, these values decreased observing and evaluating the clinical status of the patient
Time Frame
24,48,72,96,120 hours post dose
Other Pre-specified Outcome Measures:
Title
Complications associated by the epidural catheter
Description
Complications by epidural catheter placement
Time Frame
24,48,72,96, 120 hours post epidural block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute pancreatitis Patients who agree to participate in the study Exclusion Criteria: Patients who do not agree to participate in the study Patients who experience any absolute contraindication to epidural block Patients with platelet counts below 80,000 mcl Patients with data gastrointestinal or urinary bleeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurora Guadalupe Ruiz Sandoval, Anesthesia
Phone
(045) 5591852731
Email
rusa2910@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Gerardo Motta Amezquita, Anesthesia
Phone
(045) 5529621028
Email
rusa2910@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurora Guadalupe Ruiz Sandoval, anesthesia
Organizational Affiliation
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora Guadalupe Ruiz Sandoval
City
México, D.F
State/Province
Distrito Federal
ZIP/Postal Code
04260
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurora Guadalupe Ruiz Sandoval, Anesthesia
Phone
(045) 5591852732
Email
rusa2910@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gerardo Motta Amezquita, Anesthesia
Phone
(045) 5529621028
Email
rusa2910@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22487519
Citation
Barreto SG, Saccone GT. Pancreatic nociception--revisiting the physiology and pathophysiology. Pancreatology. 2012 Mar-Apr;12(2):104-12. doi: 10.1016/j.pan.2012.02.010. Epub 2012 Feb 24.
Results Reference
background
PubMed Identifier
24054878
Citation
Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
Results Reference
result
PubMed Identifier
16521220
Citation
Demirag A, Pastor CM, Morel P, Jean-Christophe C, Sielenkamper AW, Guvener N, Mai G, Berney T, Frossard JL, Buhler LH. Epidural anaesthesia restores pancreatic microcirculation and decreases the severity of acute pancreatitis. World J Gastroenterol. 2006 Feb 14;12(6):915-20. doi: 10.3748/wjg.v12.i6.915.
Results Reference
result
PubMed Identifier
9539611
Citation
Steinbrook RA. Epidural anesthesia and gastrointestinal motility. Anesth Analg. 1998 Apr;86(4):837-44. doi: 10.1097/00000539-199804000-00029. No abstract available.
Results Reference
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PubMed Identifier
20012652
Citation
Hirota M, Takada T, Kitamura N, Ito T, Hirata K, Yoshida M, Mayumi T, Kataoka K, Takeda K, Sekimoto M, Hirota M, Kimura Y, Wada K, Amano H, Gabata T, Arata S, Yokoe M, Kiriyama S. Fundamental and intensive care of acute pancreatitis. J Hepatobiliary Pancreat Sci. 2010 Jan;17(1):45-52. doi: 10.1007/s00534-009-0210-7. Epub 2009 Dec 12.
Results Reference
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Citation
Simón Hew. Acute pancreatitis: an intensive care perspective. Anteshesia and intensive care medicine. 2012; 171-175
Results Reference
result
PubMed Identifier
18191686
Citation
Frossard JL, Steer ML, Pastor CM. Acute pancreatitis. Lancet. 2008 Jan 12;371(9607):143-52. doi: 10.1016/S0140-6736(08)60107-5.
Results Reference
result
Citation
Manuel Díaz de León. Diagnóstico y tratamiento de la pancreatitis aguda grave. Medicina crítica y terapia intensiva. 2003 (17):104-10
Results Reference
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PubMed Identifier
18388680
Citation
Skipworth JR, Pereira SP. Acute pancreatitis. Curr Opin Crit Care. 2008 Apr;14(2):172-8. doi: 10.1097/MCC.0b013e3282f6a3f9.
Results Reference
result
PubMed Identifier
25685727
Citation
Siniscalchi A, Gamberini L, Laici C, Bardi T, Faenza S. Thoracic epidural anesthesia: Effects on splanchnic circulation and implications in Anesthesia and Intensive care. World J Crit Care Med. 2015 Feb 4;4(1):89-104. doi: 10.5492/wjccm.v4.i1.89. eCollection 2015 Feb 4.
Results Reference
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Citation
J. Gil Sebrián. Analgesia y sedación en la pancreatitis aguda. Med intensiva 2003;27(2):116-28
Results Reference
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PubMed Identifier
21562445
Citation
Layer P, Bronisch HJ, Henniges UM, Koop I, Kahl M, Dignass A, Ell C, Freitag M, Keller J. Effects of systemic administration of a local anesthetic on pain in acute pancreatitis: a randomized clinical trial. Pancreas. 2011 Jul;40(5):673-9. doi: 10.1097/MPA.0b013e318215ad38.
Results Reference
result

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Epidural Anesthesia in Acute Pancreatitis

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