Pancreatitis, AcuteTAPANCT04037449
Transversus Abdominis Plane Block in the Analgesia of Acute Pancreatitis
A study testing TAP block and Conventional analgesia in people with Pancreatitis, Acute, run by Consorci Sanitari Integral.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatitis, Acute
- What is being tested?
- TAP block and Conventional analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with American Society of Anaesthesia (ASA) levels IV and V
- Patients with chronic pancreatitis
- Pregnancy
- Patients with chronic treatment with morphic medication
About this study
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
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.
Read more
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.
- Conditions
- Pancreatitis, Acute
- Being tested
- TAP block, Conventional analgesia
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
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
Conventional analgesiaOther
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)
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | 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. Receives: Procedure: TAP block |
| Conventional analgesia | Active comparator | 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 Receives: Other: Conventional analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
Complications
Complications related to the analgesic technique used, either by the administration procedure or as a side effect
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start30 Nov 2020 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037449
- Sponsor's protocol ID
- 19/35
- Acronym
- TAPA
- Status last verified
- Nov 2020
- First submitted
- 27 May 2019
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04037449
- Acronym / sponsor ID
- TAPA / 19/35
- Conditions
- Pancreatitis, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Experimental | Procedure: TAP blockTransversus 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 | Active comparator | Other: Conventional analgesiaPatients 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with American Society of Anaesthesia (ASA) levels IV and V
- Patients with chronic pancreatitis
- Pregnancy
- Patients with chronic treatment with morphic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP blockWith 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 | Procedure or surgery | TAP block |
| Conventional analgesiaIntravenous 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) | Other | Conventional analgesia |
Primary outcome
Change of pain levels (VAS) after the intervention
Time frame: 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.
1 secondary outcome
Complications
Time frame: through study completion, an average of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block and Conventional analgesia in people with Pancreatitis, Acute, run by Consorci Sanitari Integral.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain levels (VAS) after the intervention (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.