NCT02617199

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

November 14, 2015

Last Update Submit

January 7, 2016

Conditions

Acute Pancreatitis

Keywords

epidural anesthesiapain managementmicrocirculation

Outcome Measures

Primary Outcomes (1)

  • Hospital days stay between two groups

    Day hospital stay were compared between the analgesic management with epidural and intravenous analgesic management

    10-15 days

Secondary Outcomes (2)

  • Efficacy of Epidural pain control

    24, 48, 72, 96,120 hours

  • Decreased pancreatic enzymes

    24,48,72,96,120 hours post dose

Other Outcomes (1)

  • Complications associated by the epidural catheter

    24,48,72,96, 120 hours post epidural block

Study Arms (2)

Epidural anesthesia

EXPERIMENTAL

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

intravenous analgesia

ACTIVE COMPARATOR

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

Interventions

Epidural anesthesiaDRUG

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

Also known as: ropivacaine + fentanyl epidural
Epidural anesthesia
intravenous analgesiaDRUG

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

Also known as: nonsteroidal analgesics + opioids intravenous
intravenous analgesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute pancreatitis
  • Patients who agree to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurora Guadalupe Ruiz Sandoval

México, D.F, Mexico City, 04260, Mexico

RECRUITING

Related Publications (12)

  • 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.

    PMID: 22487519BACKGROUND

  • 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.

    PMID: 24054878RESULT

  • 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.

    PMID: 16521220RESULT

  • Steinbrook RA. Epidural anesthesia and gastrointestinal motility. Anesth Analg. 1998 Apr;86(4):837-44. doi: 10.1097/00000539-199804000-00029. No abstract available.

    PMID: 9539611RESULT

  • 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.

    PMID: 20012652RESULT

  • Simón Hew. Acute pancreatitis: an intensive care perspective. Anteshesia and intensive care medicine. 2012; 171-175

    RESULT

  • Frossard JL, Steer ML, Pastor CM. Acute pancreatitis. Lancet. 2008 Jan 12;371(9607):143-52. doi: 10.1016/S0140-6736(08)60107-5.

    PMID: 18191686RESULT

  • Manuel Díaz de León. Diagnóstico y tratamiento de la pancreatitis aguda grave. Medicina crítica y terapia intensiva. 2003 (17):104-10

    RESULT

  • Skipworth JR, Pereira SP. Acute pancreatitis. Curr Opin Crit Care. 2008 Apr;14(2):172-8. doi: 10.1097/MCC.0b013e3282f6a3f9.

    PMID: 18388680RESULT

  • 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.

    PMID: 25685727RESULT

  • J. Gil Sebrián. Analgesia y sedación en la pancreatitis aguda. Med intensiva 2003;27(2):116-28

    RESULT

  • 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.

    PMID: 21562445RESULT

MeSH Terms

Conditions

PancreatitisAgnosia

Interventions

Anesthesia, EpiduralRopivacaine

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Aurora Guadalupe Ruiz Sandoval, anesthesia

    Hospital General Naval de Alta Especialidad - Escuela Medico Naval

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurora Guadalupe Ruiz Sandoval, Anesthesia

CONTACT

(045) 5591852731rusa2910@hotmail.com

Luis Gerardo Motta Amezquita, Anesthesia

CONTACT

(045) 5529621028rusa2910@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2015

First Posted

November 30, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

ME(1)