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Epidural Anesthesia in Acute Pancreatitis

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02617199
Enrollment
60
Registered
2015-11-30
Start date
2015-11-30
Completion date
2017-02-28
Last updated
2016-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Keywords

epidural anesthesia, pain management, microcirculation

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.

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.

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

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

Sponsors

Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital days stay between two groups10-15 daysDay hospital stay were compared between the analgesic management with epidural and intravenous analgesic management

Secondary

MeasureTime frameDescription
Efficacy of Epidural pain control24, 48, 72, 96,120 hoursMeasured by pain scales the effectiveness of epidural use as an analgesic in acute pancreatitis
Decreased pancreatic enzymes24,48,72,96,120 hours post doseRecording every 24 hours of laboratory values, these values decreased observing and evaluating the clinical status of the patient

Other

MeasureTime frameDescription
Complications associated by the epidural catheter24,48,72,96, 120 hours post epidural blockComplications by epidural catheter placement

Countries

Mexico

Contacts

Primary ContactAurora Guadalupe Ruiz Sandoval, Anesthesia
rusa2910@hotmail.com(045) 5591852731
Backup ContactLuis Gerardo Motta Amezquita, Anesthesia
rusa2910@hotmail.com(045) 5529621028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026