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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm; Abdominal Aortic Stenosis; Syndrome, Leriche
• Intervention / Treatment: Other: ropivacaine; Other: normal saline

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gordan Mijovski, MD; Phone Number: +38615223810; Email: gordan.mijovski@kclj.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • UMCLjubljana
    • Contact: Vanja Oven, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ropivacaine; Participants in this group will receive TAP block with 0,75%, bilaterally.	Other: ropivacaine; single shot bilateral TAP block
Placebo Comparator: normal saline; Participants in this group will receive TAP block with normal saline, bilaterally.	Other: normal saline; single shot bilateral TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay after surgery measured in days	up to 2 weeks
Return of peristalsis	Return of peristalsis after surgery measured in days	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	up to 7 days postoperatively

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Principal Investigator: Gordan Mijovski, MD, UMC Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Abdominal aorta, TAP
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Diseases; Aortic Valve Stenosis; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Leriche Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: TAP study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No