Acute PancreatitisPhase 2/3NCT02617199
Epidural Anesthesia in Acute Pancreatitis
A Phase 2/3 study testing Epidural anesthesia and intravenous analgesia in people with Acute Pancreatitis, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Epidural anesthesia and intravenous analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2015to Feb 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute pancreatitis
- Patients who agree to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Aurora Guadalupe Ruiz Sandoval
México, D.F, Mexico City, 04260
Aurora Guadalupe Ruiz Sandoval, Anesthesia, (045) 5591852732, rusa2910@hotmail.com
Gerardo Motta Amezquita, Anesthesia, (045) 5529621028, rusa2910@hotmail.com
About this study
Official title: Epidural Anesthesia as an Alternative for Management in Acute Pancreatitis, a Randomised Clinical Trial
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.
- Conditions
- Acute Pancreatitis
- Being tested
- Epidural anesthesia, intravenous analgesia
- Keywords
- epidural anesthesia, pain management, microcirculation
- Medical subject headings
- Pancreatitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaDrug
Also called ropivacaine + fentanyl epidural
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 analgesiaDrug
Also called nonsteroidal analgesics + opioids intravenous
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital days stay between two groups
Day hospital stay were compared between the analgesic management with epidural and intravenous analgesic management
Measured: 10-15 days
Secondary outcomes (2)
Efficacy of Epidural pain control
Measured by pain scales the effectiveness of epidural use as an analgesic in acute pancreatitis
Measured: 24, 48, 72, 96,120 hours
Decreased pancreatic enzymes
Recording every 24 hours of laboratory values, these values decreased observing and evaluating the clinical status of the patient
Measured: 24,48,72,96,120 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico Naval
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aurora Guadalupe Ruiz Sandoval, anesthesia, Principal investigator, Hospital General Naval de Alta Especialidad - Escuela Medico Naval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617199
- Sponsor's protocol ID
- HGNAE-08
- Status last verified
- Jan 2016
- First submitted
- 14 Nov 2015
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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 22487519Working 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 24054878Demirag 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 16521220Steinbrook RA. Epidural anesthesia and gastrointestinal motility. Anesth Analg. 1998 Apr;86(4):837-44. doi: 10.1097/00000539-199804000-00029. No abstract available.
PubMed 9539611Hirota 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 20012652Simón 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 18191686Manuel 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 18388680Siniscalchi 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 25685727J. 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Anesthesia as an Alternative for Management in Acute Pancreatitis, a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02617199
- Acronym / sponsor ID
- HGNAE-08
- Conditions
- Acute Pancreatitis
- Keywords
- epidural anesthesia, pain management, microcirculation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico NavalOther government
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural anesthesia | Experimental | Drug: Epidural anesthesiaEpidural 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 | Active comparator | Drug: intravenous analgesiaketorolac 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with acute pancreatitis
- Patients who agree to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural anesthesiaAlso: ropivacaine + fentanyl epiduralEpidural 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 analgesiaAlso: nonsteroidal analgesics + opioids intravenousketorolac 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 |
Primary outcome
Hospital days stay between two groups
Time frame: 10-15 days
Day hospital stay were compared between the analgesic management with epidural and intravenous analgesic management
2 secondary outcomes
Efficacy of Epidural pain control
Time frame: 24, 48, 72, 96,120 hours
Decreased pancreatic enzymes
Time frame: 24,48,72,96,120 hours post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Background: PubMed 22487519Barreto 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 publication: PubMed 24054878Working 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 publication: PubMed 16521220Demirag 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 publication: PubMed 9539611Steinbrook RA. Epidural anesthesia and gastrointestinal motility. Anesth Analg. 1998 Apr;86(4):837-44. doi: 10.1097/00000539-199804000-00029. No abstract available.
- Results publication: PubMed 20012652Hirota 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 publicationSimón Hew. Acute pancreatitis: an intensive care perspective. Anteshesia and intensive care medicine. 2012; 171-175
- Results publication: PubMed 18191686Frossard JL, Steer ML, Pastor CM. Acute pancreatitis. Lancet. 2008 Jan 12;371(9607):143-52. doi: 10.1016/S0140-6736(08)60107-5.
- Results publicationManuel Díaz de León. Diagnóstico y tratamiento de la pancreatitis aguda grave. Medicina crítica y terapia intensiva. 2003 (17):104-10
- Results publication: PubMed 18388680Skipworth JR, Pereira SP. Acute pancreatitis. Curr Opin Crit Care. 2008 Apr;14(2):172-8. doi: 10.1097/MCC.0b013e3282f6a3f9.
- Results publication: PubMed 25685727Siniscalchi 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 publicationJ. Gil Sebrián. Analgesia y sedación en la pancreatitis aguda. Med intensiva 2003;27(2):116-28
- Results publication: PubMed 21562445Layer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurora Guadalupe Ruiz Sandoval, anesthesia principal investigator
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Epidural anesthesia and intravenous analgesia in people with Acute Pancreatitis, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurora Guadalupe Ruiz Sandoval, Anesthesia ((045) 5591852731, rusa2910@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital days stay between two groups (time frame: 10-15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617199, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.