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

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05860452

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm Abdominal Aortic Stenosis Syndrome, Leriche	Other: ropivacaine Other: normal saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
Return of peristalsis [up to 2 weeks]
Return of peristalsis after surgery measured in days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.