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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine | Active Comparator | Participants in this group will receive TAP block with 0,75%, bilaterally. |
|
| normal saline | Placebo Comparator | Participants in this group will receive TAP block with normal saline, bilaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine | Other | single shot bilateral TAP block |
| |
| normal saline |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Length of hospital stay 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordan Mijovski, MD | UMC Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMCLjubljana | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D007925 | Leriche Syndrome |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
| Other |
single shot bilateral TAP block |
|
| up to 7 days postoperatively |
| Return of peristalsis | Return of peristalsis after surgery measured in days | up to 2 weeks |
| D001018 |
| Aortic Diseases |
| D001157 | Arterial Occlusive Diseases |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |