Epidural Anesthesia in Acute Pancreatitis

NCT ID: NCT02617199

Last Updated: 2016-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Pancreatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Epidural anesthesia

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

intravenous analgesia

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ropivacaine + fentanyl epidural nonsteroidal analgesics + opioids intravenous

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aurora Guadalupe Ruiz Sandoval, anesthesia

Role: PRINCIPAL_INVESTIGATOR

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aurora Guadalupe Ruiz Sandoval

México, D.F, Mexico City, Mexico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aurora Guadalupe Ruiz Sandoval, Anesthesia

Role: CONTACT

(045) 5591852731

Luis Gerardo Motta Amezquita, Anesthesia

Role: CONTACT

(045) 5529621028

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aurora Guadalupe Ruiz Sandoval, Anesthesia

Role: primary

(045) 5591852732

Gerardo Motta Amezquita, Anesthesia

Role: backup

(045) 5529621028

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22487519 (View on PubMed)

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.

Reference Type RESULT
PMID: 24054878 (View on PubMed)

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.

Reference Type RESULT
PMID: 16521220 (View on PubMed)

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

Reference Type RESULT
PMID: 9539611 (View on PubMed)

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.

Reference Type RESULT
PMID: 20012652 (View on PubMed)

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

Reference Type 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.

Reference Type RESULT
PMID: 18191686 (View on PubMed)

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

Reference Type RESULT

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

Reference Type RESULT
PMID: 18388680 (View on PubMed)

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.

Reference Type RESULT
PMID: 25685727 (View on PubMed)

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

Reference Type 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.

Reference Type RESULT
PMID: 21562445 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HGNAE-08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.