Isobaric versus hyperbaric intrathecal bupivacaine: influence of specific density on blood pressure change during elective total knee arthroplasty with spinal anesthesia

Isobaric versus hyperbaric intrathecal bupivacaine: influence of baricity on blood pression variation during elective total knee arthroplasty: a randomized clinical trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000857-10-BE

Enrollment

Registered

2022-04-14

Start date

2022-05-16

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total knee arthroplasty

Interventions

Trade Name: MARCAINE HYPERBARE 0,5% Pharmaceutical Form: Solution for injection INN or Proposed INN: Chlorhydrate de Bupivacaine Other descriptive name: BUPIVACAINE HYDROCHLORIDE Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Total knee arthroplasty with spinal anesthesia in patients >18 years old American Society of Anesthesiologists Physical Status I or II Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27

Exclusion criteria

Exclusion criteria: Patient refusal Spinal anesthesia contrindications History of lumbar arthrodesis surgery Body Mass Index >35 Heart failure Heart valves diseases Uncontrolled arterial hypertension Kidney disease (KADIGO 3 or more) Height 190 cm

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the hemodynamic effects by comparing the mean pressure nadir during the first hour after spinal anesthesia and time to achieve it. Primary endpoint is to demonstrate that the use of isobaric bupivacaine will induce a fall in blood pressure of less than 20% of the patient's baseline mean arterial pressure compared with hyperbaric bupivacaine during the first hour. ;Secondary Objective: Secondary objectives are to evaluate differences between the two groups in terms of use of vasoactive and sympathomimetic drugs and perioperative complications such as nausea and vomiting, duration and extent of anesthetic blockade, and delay to achieve complete motor blockade. ;Primary end point(s): Nadir of mean arterial pression during first hour after spinal anesthesia ;Timepoint(s) of evaluation of this end point: First hour after intrathecal injection of local anesthetic	—

Measure

Time frame

Main Objective: The primary objective is to assess the hemodynamic effects by comparing the mean pressure nadir during the first hour after spinal anesthesia and time to achieve it. Primary endpoint is to demonstrate that the use of isobaric bupivacaine will induce a fall in blood pressure of less than 20% of the patient's baseline mean arterial pressure compared with hyperbaric bupivacaine during the first hour. ;Secondary Objective: Secondary objectives are to evaluate differences between the two groups in terms of use of vasoactive and sympathomimetic drugs and perioperative complications such as nausea and vomiting, duration and extent of anesthetic blockade, and delay to achieve complete motor blockade. ;Primary end point(s): Nadir of mean arterial pression during first hour after spinal anesthesia ;Timepoint(s) of evaluation of this end point: First hour after intrathecal injection of local anesthetic

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Secondary

Measure	Time frame
Secondary end point(s): Cardiac rate Mean, diastolic and systolic arterial pression evolution during first hour after spinal anesthesia Intraoperative and postoperative nausea and vomiting incidence Dermatomes concerned by the sensory blockade Delay of motor block onset (inability to bend the thigh on the trunk);Timepoint(s) of evaluation of this end point: During first hour after spinal anesthesia	—

Measure

Time frame

Secondary end point(s): Cardiac rate Mean, diastolic and systolic arterial pression evolution during first hour after spinal anesthesia Intraoperative and postoperative nausea and vomiting incidence Dermatomes concerned by the sensory blockade Delay of motor block onset (inability to bend the thigh on the trunk);Timepoint(s) of evaluation of this end point: During first hour after spinal anesthesia

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Countries

Belgium

Contacts

Public ContactNicolas Piette

CHU de Liège

003242843824

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Apr 2, 2026