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

Not Applicable

Completed

• Conditions: Abdominal Aortic Stenosis; Syndrome, Leriche; Abdominal Aortic Aneurysm
• Interventions: Other: normal saline; Other: ropivacaine

• Registration Number: NCT05860452
• Lead Sponsor: University Medical Centre Ljubljana

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.

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 Timeline

• Study First Submitted: 2023-04-23
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Study Start: 2023-06-01
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	normal saline	Participants in this group will receive TAP block with normal saline, bilaterally.
ropivacaine	ropivacaine	Participants in this group will receive TAP block with 0,75%, bilaterally.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Return of peristalsis	up to 2 weeks	Return of peristalsis after surgery measured in days
Length of hospital stay	up to 2 weeks	Length of hospital stay after surgery measured in days
Patient satisfaction with pain relief	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

Trial Locations

Locations (1)

UMCLjubljana; 🇸🇮 Ljubljana, Slovenia