Transversus Abdominis Plane Block in the Analgesia of Acute Pancreatitis

Not Applicable

• Conditions: Pancreatitis, Acute
• Interventions: Procedure: TAP block; Other: Conventional analgesia

• Registration Number: NCT04037449
• Lead Sponsor: Consorci Sanitari Integral

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10
• Study Start: 2020-11-30
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block	TAP block	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.
Conventional analgesia	Conventional analgesia	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

Primary Outcome Measures

Name	Time	Method
Change of pain levels (VAS) after the intervention	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	To assess the VAS value in order to measure the time elapsed from the intervention until reaching the appropriate level of analgesic efficacy. Analgesic efficacy is defined as the patient having a pain VAS value ≤ 3.

Secondary Outcome Measures

Name	Time	Method
Complications	through study completion, an average of 30 days	Complications related to the analgesic technique used, either by the administration procedure or as a side effect