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Status unknownNCT02617199Updated Jan 11, 2016

Epidural Anesthesia in Acute Pancreatitis

A Phase 2/3 interventional study of Epidural anesthesia and intravenous analgesia in Acute Pancreatitis, sponsored by Hospital General Naval de Alta Especialidad - Escuela Medico Naval. Status unknown at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-11.

Sponsored by Hospital General Naval de Alta Especialidad - Escuela Medico Naval · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Acute Pancreatitis

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Keywords

  • epidural anesthesia
  • pain management
  • microcirculation
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In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with acute pancreatitis
  2. Patients who agree to participate in the study

Exclusion criteria

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
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugEpidural 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

    Also known as: ropivacaine + fentanyl epidural

  • Drugintravenous 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

    Also known as: nonsteroidal analgesics + opioids intravenous

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What researchers measure

Primary outcomes

  1. Hospital days stay between two groups

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

    Time frame: 10-15 days

Secondary outcomes

  1. Efficacy of Epidural pain control

    Measured by pain scales the effectiveness of epidural use as an analgesic in acute pancreatitis

    Time frame: 24, 48, 72, 96,120 hours

  2. Decreased pancreatic enzymes

    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 outcomes

  1. Complications associated by the epidural catheter

    Complications by epidural catheter placement

    Time frame: 24,48,72,96, 120 hours post epidural block

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Study locations

1 of 1 sites recruiting
  • Aurora Guadalupe Ruiz Sandoval
    México, D.F, Distrito Federal 04260, Mexico
    Recruiting
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References and documents

Publications

  • 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. PubMed 22487519 ↗
  • 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. PubMed 24054878 ↗
  • 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. PubMed 16521220 ↗
  • Steinbrook RA. Epidural anesthesia and gastrointestinal motility. Anesth Analg. 1998 Apr;86(4):837-44. doi: 10.1097/00000539-199804000-00029. No abstract available. PubMed 9539611 ↗
  • 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. PubMed 20012652 ↗
  • Simón Hew. Acute pancreatitis: an intensive care perspective. Anteshesia and intensive care medicine. 2012; 171-175
  • Frossard JL, Steer ML, Pastor CM. Acute pancreatitis. Lancet. 2008 Jan 12;371(9607):143-52. doi: 10.1016/S0140-6736(08)60107-5. PubMed 18191686 ↗
  • Manuel Díaz de León. Diagnóstico y tratamiento de la pancreatitis aguda grave. Medicina crítica y terapia intensiva. 2003 (17):104-10
  • Skipworth JR, Pereira SP. Acute pancreatitis. Curr Opin Crit Care. 2008 Apr;14(2):172-8. doi: 10.1097/MCC.0b013e3282f6a3f9. PubMed 18388680 ↗
  • 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. PubMed 25685727 ↗
  • J. Gil Sebrián. Analgesia y sedación en la pancreatitis aguda. Med intensiva 2003;27(2):116-28
  • 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. PubMed 21562445 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02617199
Lead sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Responsible party
Sponsor
First posted
Nov 30, 2015
Start date
Nov 2015
Primary completion
Dec 2016 (estimated)
Completion
Feb 2017 (estimated)
Last update
Jan 11, 2016

Study contacts

Aurora Guadalupe Ruiz Sandoval, Anesthesia
Contact
rusa2910@hotmail.com
(045) 5591852731
Luis Gerardo Motta Amezquita, Anesthesia
Contact
rusa2910@hotmail.com
(045) 5529621028
Aurora Guadalupe Ruiz Sandoval, anesthesia
principal investigator · Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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