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Transversus Abdominis Plane Block in the Analgesia of Acute Pancreatitis

44 participantsStarted 2020-11-30

Plain-language summary

Background Severe abdominal pain is a hallmark of acute pancreatitis (AP). A control pain is often difficult. Transversus Abdominis Plane (TAP) block has been used in pain control in patients with exacerbation of chronic pancreatitis. Objectives To evaluate the effect of Bilateral Blockade of the Abdominal Transverse Muscle Plane (TAP Block) in the analgesic control of patients with acute pancreatitis; compared to standard intravenous analgesia. Methods A randomized controlled trial of parallel groups will be conducted. The Study will have a multicenter development. Study population: Adult patients admitted for episode of AP, with uncontrolled pain (visual analogue scale (VAS) equal to or greater than 5 after the administration of standard analgesia. Randomization Groups: Group A: Patients who will undergo TAP block as analgesic procedure added to standard analgesia. Group B: Patients to whom morphine 2 mg / ev will be administered as analgesic procedure added to standard analgesia. Timing of pain determination (Visual Analogue Scale, VAS): * Before conventional analgesia * Immediately before Randomization * 15 minutes after the administration of the analgesic treatment object of the study. * One hour after the procedure. * Every 8 hours, during the next 4 days or until discharge of the patient. * Whenever the patient needs a dose of supplemental rescue analgesia. Analysis of data All results will be evaluated according to the initial "intention to treat". There will be a blinded assessment of the results after the last patient in the trial has completed the follow-up. The results will be presented as relative risks with their corresponding confidence intervals. P \<0.05 will be considered statistically significant. In case of imbalance between the two treatment groups, a multivariate logistic regression is used to correct possible confounding factors.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of acute pancreatitis according to modified Atlanta criteria . * Patients with the ability to understand the VAS scale and express their level of pain. * Patients over 18 years old. * Uncontrolled pain, with VAS ≥ 5 after the administration of standard analgesia. * Material and technical possibility of performing the TAP technique immediately after randomization. * Informed consent of the participating patients for inclusion in the study. * Informed consent of the participating patients for the administration of TAP. * Normality of coagulation levels Exclusion Criteria: * Patients with American Society of Anaesthesia (ASA) levels IV and V * Patients with chronic pancreatitis * Pregnancy * Patients with chronic treatment with morphic medication

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of pain levels (VAS) after the intervention

Timeframe: Baseline (Before the intervention), 15 minutes after the intervention, 1 hour after the intervention, 8 hours after the intervention, 16 hours after the intervention, 24 hours after the intervention

Trial details

NCT IDNCT04037449

SponsorConsorci Sanitari Integral

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-30

View on ClinicalTrials.gov More Pancreatitis, Acute trials