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

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860452
• Other study ID #: TAP study
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University Medical Centre Ljubljana
• Contact: Gordan Mijovski, MD
• Phone: +38615223810
• Email: gordan.mijovski[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Valve Stenosis
• Leriche Syndrome

Intervention

Other:
• ropivacaine
single shot bilateral TAP block
• normal saline
single shot bilateral TAP block

Locations

Country	Name	City	State
Slovenia	UMCLjubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of hospital stay	Length of hospital stay after surgery measured in days	up to 2 weeks
Secondary	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
Secondary	Return of peristalsis	Return of peristalsis after surgery measured in days	up to 2 weeks