Hypobaric vs hyperbaric bupivacaine for spinal anaesthesia in total knee arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019669-27-EE

Enrollment

Registered

2010-04-13

Start date

2010-04-30

Completion date

Unknown

Last updated

2013-05-27

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

Conditions

Orthopedic surgery patients with elective total knee arthroplasty

Interventions

Trade Name: Marcaine Spinal 0.5% Pharmaceutical Form: Solution for injection INN or Proposed INN: BUPIVACAINE CAS Number: 2180929 Current Sponsor code: PR1 Concentration unit: mg/ml milligram(s)/milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients aged between 18-80 years, who have elective total knee arthroplasty 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients without consent wit study 2. Patients, without consent for regional anesthesia

Design outcomes

Primary

Measure	Time frame
Main Objective: To define, which drug formulation hyperbaric marcaine or hypobaric marcaine, which are used for induction of one-side spinal anesthesia, gives more profound one-side blockade after turning patients supine;Secondary Objective: 1. To define satisfaction of surgeon with operative conditions and muscle relaxation, in particular. 2. To define patient satisfaction with anesthesia;Primary end point(s): Stable one-side spinal anesthesia 20 min after turning patient supine. Why this is important? 1. Patient satisfaction are higher with one-side block, beacuse of not being paralysed on both sides 2. Hemodynamics changes less during that kind of anesthesia and the risks associated with low blood pressure and bradycardia are smaller	—

Measure

Time frame

Main Objective: To define, which drug formulation hyperbaric marcaine or hypobaric marcaine, which are used for induction of one-side spinal anesthesia, gives more profound one-side blockade after turning patients supine;Secondary Objective: 1. To define satisfaction of surgeon with operative conditions and muscle relaxation, in particular. 2. To define patient satisfaction with anesthesia;Primary end point(s): Stable one-side spinal anesthesia 20 min after turning patient supine. Why this is important? 1. Patient satisfaction are higher with one-side block, beacuse of not being paralysed on both sides 2. Hemodynamics changes less during that kind of anesthesia and the risks associated with low blood pressure and bradycardia are smaller

—

Countries

Estonia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026