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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05860452
Other study ID # TAP study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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