Epidural Anesthesia in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

Epidural Anesthesia as an Alternative for Management in Acute Pancreatitis, a Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02617199
• Other study ID #: HGNAE-08
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 14, 2015
• Last updated: January 7, 2016
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: January 2016
• Source: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
• Contact: Aurora Guadalupe Ruiz Sandoval, Anesthesia
• Phone: (045) 5591852731
• Email: rusa2910[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

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
• 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

Locations

Country	Name	City	State
Mexico	Aurora Guadalupe Ruiz Sandoval	México, D.F	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Country where clinical trial is conducted

Mexico, 

References & 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. Review. — View Citation

Demirag A, Pastor CM, Morel P, Jean-Christophe C, Sielenkämper AW, Güvener N, Mai G, Berney T, Frossard JL, Bühler LH. Epidural anaesthesia restores pancreatic microcirculation and decreases the severity of acute pancreatitis. World J Gastroenterol. 2006 — View 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. Review. — View 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 Pancr — View Citation

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 — View Citation

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

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

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. eCollect — View Citation

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

Steinbrook RA. Epidural anesthesia and gastrointestinal motility. Anesth Analg. 1998 Apr;86(4):837-44. Review. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications associated by the epidural catheter	Complications by epidural catheter placement	24,48,72,96, 120 hours post epidural block	Yes
Primary	Hospital days stay between two groups	Day hospital stay were compared between the analgesic management with epidural and intravenous analgesic management	10-15 days	Yes
Secondary	Efficacy of Epidural pain control	Measured by pain scales the effectiveness of epidural use as an analgesic in acute pancreatitis	24, 48, 72, 96,120 hours	Yes
Secondary	Decreased pancreatic enzymes	Recording every 24 hours of laboratory values, these values decreased observing and evaluating the clinical status of the patient	24,48,72,96,120 hours post dose	Yes