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

NCT05860452 | Completed

• 1 other identifier: TAP study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Aortic Aneurysm; Abdominal Aortic Stenosis; Syndrome, Leriche

Keywords

Abdominal aorta, TAP

Outcome Measures

Primary Outcomes (1)

• Cumulative dose of opioid in the first 48 hours after surgery

  Cumulative dose of opioid, administered in the first 48 hours after surgery

  48 hours after surgery

Secondary Outcomes (3)

• Length of hospital stay

  up to 2 weeks

• Patient satisfaction with pain relief

  up to 7 days postoperatively

• Return of peristalsis

  up to 2 weeks

Study Arms (2)

ropivacaine

ACTIVE COMPARATOR

Participants in this group will receive TAP block with 0,75%, bilaterally.

Other: ropivacaine

normal saline

PLACEBO COMPARATOR

Participants in this group will receive TAP block with normal saline, bilaterally.

Other: normal saline

Interventions

ropivacaine OTHER

single shot bilateral TAP block

ropivacaine

normal saline OTHER

single shot bilateral TAP block

normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMCLjubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Leriche Syndrome

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gordan Mijovski, MD

  UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Dedicated anaesthetic nurse will prepare the syringes for administering the TAP block for each participant. She will be the only person to know which group each participant has been allocated to. Since local anaesthetic and normal saline have no color the anaesthetist performing the block will be, as will the doctors and nurses in postoperative care, blinded to the group each participant has been allocated to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist.dr.Gordan Mijovski dr. med.

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 16, 2023
• Study Start: June 1, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 30, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)