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OpenTrials
Completed

NCT Number: NCT05860452

Effectiveness of TAP (Transversus Abdominis Plane) Block for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMCLjubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ropivacaine

Other

single shot bilateral TAP block

Normal Saline

Other

single shot bilateral TAP block

Primary outcomes

  1. 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

Secondary outcomes

  1. Length of hospital stay

    Time frame: up to 2 weeks

    Length of hospital stay after surgery measured in days

  2. Patient satisfaction with pain relief

    Time frame: up to 7 days postoperatively

    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

  3. Return of peristalsis

    Time frame: up to 2 weeks

    Return of peristalsis after surgery measured in days

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Effectiveness of TAP (Transversus Abdominis Plane) Block for Postoperative Pain Relief After Abdominal Aortic Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 16, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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