Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

• Sponsor: Hospital da Luz, Portugal (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05954689
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 10.7

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Tourniquets; Anesthesia, Conduction; Anesthetics, Local; Hypertension	Other: Femoral artery block	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Femoral Artery Block for Reduction of Tourniquet Induced Hypertension: a Randomised Controlled Trial
• Anticipated Study Start Date: Jul 10, 2023
• Anticipated Primary Completion Date: Feb 29, 2024
• Anticipated Study Completion Date: May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Femoral artery block 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.	Other: Femoral artery block; Injection on the antero-medial side of the femoral artery of 10mL 0.5% ropivacaine with ultrasound guidance.
No Intervention: No intervention

Outcome Measures

Primary Outcome Measures

1. Incidence of Tourniquet Hypertension (TH) [Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia)]

   Defined as Systolic Blood Pressure (SBP) increased >30% after 30 minutes of tourniquet

2. Systolic blood pressure 30 minutes after tourniquet inflation [30 minutes after tourniquet inflation]

   SBP at 30 minutes after tourniquet inflation

3. Systolic blood pressure 45 minutes after tourniquet inflation [45 minutes after tourniquet inflation]

   SBP at 45 minutes after tourniquet inflation

4. Systolic blood pressure 60 minutes after tourniquet inflation [60 minutes after tourniquet inflation]

   SBP at 60 minutes after tourniquet inflation

5. Systolic blood pressure 75 minutes after tourniquet inflation [75 minutes after tourniquet inflation]

   SBP at 75 minutes after tourniquet inflation

6. Systolic blood pressure 90 minutes after tourniquet inflation [90 minutes after tourniquet inflation]

   SBP at 90 minutes after tourniquet inflation

7. Systolic blood pressure 115 minutes after tourniquet inflation [115 minutes after tourniquet inflation]

   SBP at 115 minutes after tourniquet inflation

8. Systolic blood pressure 130 minutes after tourniquet inflation [130 minutes after tourniquet inflation]

   SBP at 130 minutes after tourniquet inflation

9. Mean arterial pressure (MAP) 30 minutes after tourniquet inflation [30 minutes after tourniquet inflation]

   MAP at 30 minutes after tourniquet inflation

10. Mean arterial pressure 45 minutes after tourniquet inflation [45 minutes after tourniquet inflation]

    MAP at 45 minutes after tourniquet inflation

11. Mean arterial pressure 60 minutes after tourniquet inflation [60 minutes after tourniquet inflation]

    MAP at 60 minutes after tourniquet inflation

12. Mean arterial pressure 75 minutes after tourniquet inflation [75 minutes after tourniquet inflation]

    MAP at 75 minutes after tourniquet inflation

13. Mean arterial pressure 90 minutes after tourniquet inflation [90 minutes after tourniquet inflation]

    MAP at 90 minutes after tourniquet inflation

14. Mean arterial pressure 115 minutes after tourniquet inflation [115 minutes after tourniquet inflation]

    MAP at 115 minutes after tourniquet inflation

15. Mean arterial pressure 130 minutes after tourniquet inflation [130 minutes after tourniquet inflation]

    MAP at 130 minutes after tourniquet inflation

16. Systolic blood pressure variation from baseline at 30 minutes after tourniquet inflation [30 minutes after tourniquet inflation]

    Variation of SBP compared to baseline at 30 minutes after tourniquet inflation

17. Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation [45 minutes after tourniquet inflation]

    Variation of SBP compared to baseline at 45 minutes after tourniquet inflation

18. Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation [60 minutes after tourniquet inflation]

    Variation of SBP compared to baseline at 60 minutes after tourniquet inflation

19. Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation [75 minutes after tourniquet inflation]

    Variation of SBP compared to baseline at 75 minutes after tourniquet inflation

20. Systolic blood pressure variation from baseline at 90 minutes after tourniquet inflation [90 minutes after tourniquet inflation]

    Variation of SBP compared to baseline at 90 minutes after tourniquet inflation

21. Systolic blood pressure variation from baseline at 115 minutes after tourniquet inflation [115 minutes after tourniquet inflation]

    Variation of SBP compared to baseline at 115 minutes after tourniquet inflation

22. Systolic blood pressure variation from baseline at 130 minutes after tourniquet inflation [130 minutes after tourniquet inflation]

    Variation of SBP compared to baseline at 130 minutes after tourniquet inflation

23. Mean arterial pressure variation from baseline at 30 minutes after tourniquet inflation [30 minutes after tourniquet inflation]

    Variation of MAP compared to baseline at 30 minutes after tourniquet inflation

24. Mean arterial pressure variation from baseline at 45 minutes after tourniquet inflation [45 minutes after tourniquet inflation]

    Variation of MAP compared to baseline at 45 minutes after tourniquet inflation

25. Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation [60 minutes after tourniquet inflation]

    Variation of MAP compared to baseline at 60 minutes after tourniquet inflation

26. Mean arterial pressure variation from baseline at 75 minutes after tourniquet inflation [75 minutes after tourniquet inflation]

    Variation of MAP compared to baseline at 75 minutes after tourniquet inflation

27. Mean arterial pressure variation from baseline at 90 minutes after tourniquet inflation [90 minutes after tourniquet inflation]

    Variation of MAP compared to baseline at 90 minutes after tourniquet inflation

28. Mean arterial pressure variation from baseline at 115 minutes after tourniquet inflation [115 minutes after tourniquet inflation]

    Variation of MAP compared to baseline at 115 minutes after tourniquet inflation

29. Mean arterial pressure variation from baseline at 130 minutes after tourniquet inflation [130 minutes after tourniquet inflation]

    Variation of MAP compared to baseline at 130 minutes after tourniquet inflation

Secondary Outcome Measures

1. Isosorbide dinitrate administered for TH [Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) )]

   mg of isosorbide dinitrate administered for TH

2. Numerical verbal pain scores [Up to 2 hours after emergence from anesthesia]

   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)

3. Patient post-operative satisfaction [Up to 2 hours after emergence from anesthesia]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I to III

• Receiving cruciate ligament surgery with > 30 minutes of tourniquet

• Combined anesthesia (balanced general anesthesia and femoral nerve block)

Exclusion Criteria:

• Nerve block contraindications (block site infection, allergic to local anesthetic)

• Tourniquet contraindications (peripheral vascular disease or neuropathy, previous arterial bypass graft)

• Tourniquet inflation time < 30 min

• Patient refusal

• Pregnant patients

• Patients with a active psychiatric disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital da Luz, Portugal

Investigators

• Principal Investigator: Ana Filipa Duarte, Hospital da Luz, Lisboa

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Vasyl Katerenchuk, Anaesthesiology Resident, Hospital da Luz, Portugal
• ClinicalTrials.gov Identifier: NCT05954689
• Other Study ID Numbers: U1111-1293-7325
• First Posted: Jul 20, 2023
• Last Update Posted: Jul 20, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jul 20, 2023