Abdominal Aortic AneurysmNCT05860452
Effectiveness of TAP (Transversus Abdominis Plane) Block for Abdominal Aortic Surgery
A study testing ropivacaine and normal saline in people with Abdominal Aortic Aneurysm and Abdominal Aortic Stenosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The goal of this study is to learn about the effectiveness of TAP block for pain relief after vascular surgery on the abdominal aorta. The main question the investigators are looking to answer is whether the TAP block lowers the dose of opioid required after abdominal aortic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Abdominal Aortic Stenosis, Syndrome, Leriche
- What is being tested?
- ropivacaine and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2023to 30 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted for an elective vascular surgery on abdominal aorta that agree and give written consent to be included in the study.
Who cannot join
- Patients allergic to the drugs we will use in the study, local anaesthetic, nonopioid analgesics, NSAIDs.
- Patients with pain syndromes that are preoperatively already on any kind of chronic pain therapy.
- Patients that will experience surgical complications that requires reoperation will be excluded postoperatively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of TAP (Transversus Abdominis Plane) Block for Postoperative Pain Relief After Abdominal Aortic Surgery
The goal of this study is to learn about the effectiveness of TAP block for pain relief after vascular surgery on the abdominal aorta.
The main question the investigators are looking to answer is whether the TAP block lowers the dose of opioid required after abdominal aortic surgery.
Read the detailed description
The surgery on the abdominal aorta requires extended haemodynamic monitoring and is performed under general anaesthesia. After applying general anaesthesia, the patients will receive a TAP block (subcostal approach) before the start of the surgery.
During the procedure the patients will receive both opioid and nonopioid analgesics, as part of the standard perioperative protocol for abdominal aortic surgery.
After the procedure all patients will receive following the standard protocol for pain relief after abdominal aortic surgery - NSAIDs and nonopioid analgesics regularly. All patients will postoperatively receive opioid as a rescue drug as needed (PCA).
Participants will be randomly allocated in two groups, where one group will receive local anaesthetic for the TAP block and the control group will receive normal saline for the TAP block. The anaesthetist, the nurses and doctors in the postoperative care will all be blinded as to the group in which each patient is allocated.
The participants will be followed from surgery until discharge from hospital.
- Being tested
- ropivacaine, normal saline
- Keywords
- Abdominal aorta, TAP
- Medical subject headings
- Aortic Aneurysm, Abdominal, Leriche Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineOther
single shot bilateral TAP block
normal salineOther
single shot bilateral TAP block
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Active comparator | Participants in this group will receive TAP block with 0,75%, bilaterally. Receives: Other: ropivacaine |
| normal saline | Placebo comparator | Participants in this group will receive TAP block with normal saline, bilaterally. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative dose of opioid in the first 48 hours after surgery
Cumulative dose of opioid, administered in the first 48 hours after surgery
Measured: 48 hours after surgery
Secondary outcomes (3)
Length of hospital stay
Length of hospital stay after surgery measured in days
Measured: up to 2 weeks
Patient satisfaction with pain relief
The participants will be asked to grade their satisfaction of pain relief on a 5 rating satisfaction scale from 1 - 5 (where 1 is best and 5 is worst).
1.very satisfied 2.satisfied 3. neither satisfied nor dissatisfied 4.dissatisfied 5. very dissatisfied
Measured: up to 7 days postoperatively
Return of peristalsis
Return of peristalsis after surgery measured in days
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jun 2023
- Primary completion20 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gordan Mijovski, University Medical Centre Ljubljana
- Investigators
- Gordan Mijovski, MD, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860452
- Sponsor's protocol ID
- TAP study
- Status last verified
- Jan 2025
- First submitted
- 23 Apr 2023
- Last updated
- 28 Jan 2025
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of TAP (Transversus Abdominis Plane) Block for Postoperative Pain Relief After Abdominal Aortic Surgery
- ClinicalTrials.gov ID
- NCT05860452
- Acronym / sponsor ID
- TAP study
- Keywords
- Abdominal aorta, TAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 16 May 2023 (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.
The goal of this study is to learn about the effectiveness of TAP block for pain relief after vascular surgery on the abdominal aorta.
The main question the investigators are looking to answer is whether the TAP block lowers the dose of opioid required after abdominal aortic surgery.
Detailed description
The surgery on the abdominal aorta requires extended haemodynamic monitoring and is performed under general anaesthesia. After applying general anaesthesia, the patients will receive a TAP block (subcostal approach) before the start of the surgery.
During the procedure the patients will receive both opioid and nonopioid analgesics, as part of the standard perioperative protocol for abdominal aortic surgery.
After the procedure all patients will receive following the standard protocol for pain relief after abdominal aortic surgery - NSAIDs and nonopioid analgesics regularly. All patients will postoperatively receive opioid as a rescue drug as needed (PCA).
Participants will be randomly allocated in two groups, where one group will receive local anaesthetic for the TAP block and the control group will receive normal saline for the TAP block. The anaesthetist, the nurses and doctors in the postoperative care will all be blinded as to the group in which each patient is allocated.
The participants will be followed from surgery until discharge from hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Active comparator | Other: ropivacaineParticipants in this group will receive TAP block with 0,75%, bilaterally. |
| normal saline | Placebo comparator | Other: normal salineParticipants in this group will receive TAP block with normal saline, bilaterally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients admitted for an elective vascular surgery on abdominal aorta that agree and give written consent to be included in the study.
Key exclusion criteria (3 listed)
- Patients allergic to the drugs we will use in the study, local anaesthetic, nonopioid analgesics, NSAIDs.
- Patients with pain syndromes that are preoperatively already on any kind of chronic pain therapy.
- Patients that will experience surgical complications that requires reoperation will be excluded postoperatively.
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 |
|---|---|---|
| ropivacainesingle shot bilateral TAP block | Other | ropivacaine |
| normal salinesingle shot bilateral TAP block | Other | normal saline |
Primary outcome
Cumulative dose of opioid in the first 48 hours after surgery
Time frame: 48 hours after surgery
Cumulative dose of opioid, administered in the first 48 hours after surgery
3 secondary outcomes
Length of hospital stay
Time frame: up to 2 weeks
Patient satisfaction with pain relief
Time frame: up to 7 days postoperatively
Return of peristalsis
Time frame: up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- 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.
Gordan Mijovski, MD principal investigator
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine and normal saline in people with Abdominal Aortic Aneurysm and Abdominal Aortic Stenosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative dose of opioid in the first 48 hours after surgery (time frame: 48 hours after surgery). 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 28 Jan 2025.