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Transversus Abdominis Plane Block in the Analgesia of Acute Pancreatitis (TAPA)

C

Consorci Sanitari Integral

Status

Unknown

Conditions

Pancreatitis, Acute

Treatments

Other: Conventional analgesia
Procedure: TAP block

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

TAP block
Experimental group
Description:
Transversus Abdominis Plane (TAP) block technique will be carried out by a restricted group of anaesthesiologists. Standard monitoring will be applied to all patients, which will include pulse oximetry, electrocardiogram and non-invasive monitoring of blood pressure.
Treatment:
Procedure: TAP block
Conventional analgesia
Active Comparator group
Description:
Patients be given conventional endovenous analgesia, and morphine 2 mg / ev every 15 minutes until the level of pain measured by a Visual Analogue Scale (VAS) ≤ 3
Treatment:
Other: Conventional analgesia

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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