Transversus Abdominis Plane Block in the Analgesia of Acute Pancreatitis

Pancreatitis, Acute Clinical Trial

— TAPA  

Official title:

Prospective Randomized Study to Measure the Effect of Bilateral Transversus Abdominis Plane (TAP) Block in the Analgesic Control of Patients With Acute Pancreatitis (AP) and Uncontrolled Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04037449
• Other study ID #: 19/35
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2020
• Source: Consorci Sanitari Integral
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute

Intervention

Procedure:
• TAP block
With the patient placed in the supine position, after asepsis of the skin with chlorhexidine, bilateral TAP blockage will be carried out under ultrasound control. We will use a high frequency linear transducer (12-15 MHz) on one side of the abdominal wall, at the level of the mid-axillary line, between the costal margin and the iliac crest. At this level we can identify three muscle layers, from superficial to deep: external oblique muscle, internal oblique muscle and transverse muscle of the abdomen. We will move the transducer more laterally to locate the most posterior border of the internal oblique and transverse muscles. It is at this level that we perform the posterior TAP blockade: we administer 10 ml of 2% Mepivacaine plus 10 ml of 0.5% Bupivacaine between the fasciae of the internal oblique muscle and the transverse muscle of the abdomen and observe an appropriate diffusion pattern of local anesthetics

Other:
• Conventional analgesia
Intravenous dexketoprofen 50 mg / 8 hours, alternate with intravenous paracetamol 1g / 8 hours. If allergy to Nonsteroidal anti-inflammatory drugs (NSAIDs) or in case of renal failure: Intravenous metamizol 2g / 8 hours alternate with intravenous paracetamol 1g / 8 hours. Rescue Analgesia: intravenous morphine (2 mg every 15 minutes until VAS less or equal to 3)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari Integral

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pain levels (VAS) 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.	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
Secondary	Complications	Complications related to the analgesic technique used, either by the administration procedure or as a side effect	through study completion, an average of 30 days