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A randomised controlled trial to assess the impact of femoral artery block on the incidence of tourniquet hypertension in patients receiving cruciate ligament surgery with > 30 minutes of tourniquet under combined anaesthesia (balanced general anaesthesia and femoral nerve blocks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral artery block | Experimental | An experienced Anesthesiologist will perform the femoral blocks, under ultrasound guidance with a linear probe and a 50mm (millimeters) or 80mm needle. No nerve stimulator will be used during the block. In both groups, femoral nerve block at the nerve sheath will be performed with 20mL (milliliters) 0.5% ropivacaine. In the interventional group, additionally to the previous block, the needle will be retracted and advanced to the antero-medial side of the femoral artery where 10mL 0.5% ropivacaine will be injected after negative aspiration. |
|
| No intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral artery block | Other | Injection on the antero-medial side of the femoral artery of 10mL 0.5% ropivacaine with ultrasound guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Tourniquet Hypertension (TH) | Defined as Systolic Blood Pressure (SBP) increased >30% after 30 minutes of tourniquet | Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) |
| Systolic blood pressure 30 minutes after tourniquet inflation | SBP at 30 minutes after tourniquet inflation | 30 minutes after tourniquet inflation |
| Systolic blood pressure 45 minutes after tourniquet inflation | SBP at 45 minutes after tourniquet inflation | 45 minutes after tourniquet inflation |
| Systolic blood pressure 60 minutes after tourniquet inflation | SBP at 60 minutes after tourniquet inflation | 60 minutes after tourniquet inflation |
| Systolic blood pressure 75 minutes after tourniquet inflation | SBP at 75 minutes after tourniquet inflation | 75 minutes after tourniquet inflation |
| Systolic blood pressure 90 minutes after tourniquet inflation | SBP at 90 minutes after tourniquet inflation | 90 minutes after tourniquet inflation |
| Systolic blood pressure 115 minutes after tourniquet inflation | SBP at 115 minutes after tourniquet inflation | 115 minutes after tourniquet inflation |
| Measure | Description | Time Frame |
|---|---|---|
| Isosorbide dinitrate administered for TH | mg of isosorbide dinitrate administered for TH | Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) ) |
| Numerical verbal pain scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasyl HDS Katerenchuk | Contact | +351932902978 | vasylktr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ana Filipa Duarte | Hospital da Luz Lisboa, Portugal | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33510583 | Background | Guo YX, Wang GY, Cheng WJ, Yan CZ, Zhao S, Li Z, Liu P, Wang XL. Activation of Opioid Receptors Attenuates Ischemia/Reperfusion Injury in Skeletal Muscle Induced by Tourniquet Placement. Mediators Inflamm. 2021 Jan 15;2021:6699499. doi: 10.1155/2021/6699499. eCollection 2021. | |
| 36549034 | Background | Xu F, Wang X, Li Y, Gao F, Yin C, Yu J, Li W, Zhu L, Wang Q. Combined femoral artery block and femoral nerve block reduces thigh tourniquet-induced hypertension. J Clin Anesth. 2023 May;85:111039. doi: 10.1016/j.jclinane.2022.111039. Epub 2022 Dec 20. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Systolic blood pressure 130 minutes after tourniquet inflation | SBP at 130 minutes after tourniquet inflation | 130 minutes after tourniquet inflation |
| Mean arterial pressure (MAP) 30 minutes after tourniquet inflation | MAP at 30 minutes after tourniquet inflation | 30 minutes after tourniquet inflation |
| Mean arterial pressure 45 minutes after tourniquet inflation | MAP at 45 minutes after tourniquet inflation | 45 minutes after tourniquet inflation |
| Mean arterial pressure 60 minutes after tourniquet inflation | MAP at 60 minutes after tourniquet inflation | 60 minutes after tourniquet inflation |
| Mean arterial pressure 75 minutes after tourniquet inflation | MAP at 75 minutes after tourniquet inflation | 75 minutes after tourniquet inflation |
| Mean arterial pressure 90 minutes after tourniquet inflation | MAP at 90 minutes after tourniquet inflation | 90 minutes after tourniquet inflation |
| Mean arterial pressure 115 minutes after tourniquet inflation | MAP at 115 minutes after tourniquet inflation | 115 minutes after tourniquet inflation |
| Mean arterial pressure 130 minutes after tourniquet inflation | MAP at 130 minutes after tourniquet inflation | 130 minutes after tourniquet inflation |
| Systolic blood pressure variation from baseline at 30 minutes after tourniquet inflation | Variation of SBP compared to baseline at 30 minutes after tourniquet inflation | 30 minutes after tourniquet inflation |
| Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation | Variation of SBP compared to baseline at 45 minutes after tourniquet inflation | 45 minutes after tourniquet inflation |
| Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation | Variation of SBP compared to baseline at 60 minutes after tourniquet inflation | 60 minutes after tourniquet inflation |
| Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation | Variation of SBP compared to baseline at 75 minutes after tourniquet inflation | 75 minutes after tourniquet inflation |
| Systolic blood pressure variation from baseline at 90 minutes after tourniquet inflation | Variation of SBP compared to baseline at 90 minutes after tourniquet inflation | 90 minutes after tourniquet inflation |
| Systolic blood pressure variation from baseline at 115 minutes after tourniquet inflation | Variation of SBP compared to baseline at 115 minutes after tourniquet inflation | 115 minutes after tourniquet inflation |
| Systolic blood pressure variation from baseline at 130 minutes after tourniquet inflation | Variation of SBP compared to baseline at 130 minutes after tourniquet inflation | 130 minutes after tourniquet inflation |
| Mean arterial pressure variation from baseline at 30 minutes after tourniquet inflation | Variation of MAP compared to baseline at 30 minutes after tourniquet inflation | 30 minutes after tourniquet inflation |
| Mean arterial pressure variation from baseline at 45 minutes after tourniquet inflation | Variation of MAP compared to baseline at 45 minutes after tourniquet inflation | 45 minutes after tourniquet inflation |
| Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation | Variation of MAP compared to baseline at 60 minutes after tourniquet inflation | 60 minutes after tourniquet inflation |
| Mean arterial pressure variation from baseline at 75 minutes after tourniquet inflation | Variation of MAP compared to baseline at 75 minutes after tourniquet inflation | 75 minutes after tourniquet inflation |
| Mean arterial pressure variation from baseline at 90 minutes after tourniquet inflation | Variation of MAP compared to baseline at 90 minutes after tourniquet inflation | 90 minutes after tourniquet inflation |
| Mean arterial pressure variation from baseline at 115 minutes after tourniquet inflation | Variation of MAP compared to baseline at 115 minutes after tourniquet inflation | 115 minutes after tourniquet inflation |
| Mean arterial pressure variation from baseline at 130 minutes after tourniquet inflation | Variation of MAP compared to baseline at 130 minutes after tourniquet inflation | 130 minutes after tourniquet inflation |
Numerical verbal pain scores (from 0 to 10, 10 meaning higher pain) assessed 1 hour after emergence of anesthesia in the post-operative care unit (PACU)
| Up to 2 hours after emergence from anesthesia |
| Patient post-operative satisfaction | Patient post-operative satisfaction with pain treatment measured 1 hour after emergence of anesthesia in the post-operative care unit using a 5-point Likert-scale, namely: 1 - very unsatisfied, 2 - unsatisfied, 3 - neutral, 4 - satisfied, 5 - very satisfied (with higher scores meaning a higher outcome) | Up to 2 hours after emergence from anesthesia |
| 33431616 | Background | Wahal C, Grant SA, Gadsden J, Rambhia MT, Bullock WM. Femoral artery block (FAB) attenuates thigh tourniquet-induced hypertension: a prospective randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Mar;46(3):228-232. doi: 10.1136/rapm-2020-102113. Epub 2021 Jan 11. |