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Effectiveness of TAP (Transversus Abdominis Plane) Block for Abdominal Aortic Surgery

U

University Medical Centre Ljubljana

Status

Completed

Conditions

Syndrome, Leriche
Abdominal Aortic Stenosis
Abdominal Aortic Aneurysm

Treatments

Other: ropivacaine
Other: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05860452
TAP study

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients admitted for an elective vascular surgery on abdominal aorta that agree and give written consent to be included in the study.

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

ropivacaine
Active Comparator group
Description:
Participants in this group will receive TAP block with 0,75%, bilaterally.
Treatment:
Other: ropivacaine
normal saline
Placebo Comparator group
Description:
Participants in this group will receive TAP block with normal saline, bilaterally.
Treatment:
Other: normal saline

Trial contacts and locations

1

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Central trial contact

Gordan Mijovski, MD

Data sourced from clinicaltrials.gov

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