Comparison of the Efficacy of 0.5% Bupivacaine, 0.5% Levobupivacaine, and 0.5% Hyperbaric Bupivacaine

Summary

About 15 million spinal anesthesia procedures are performed worldwide each year. In the daily practice of the anesthesiologist for intrathecal use there are various local anesthetics such as bupivacaine, hyperbaric solution of bupivacaine, ropivacaine and levobupivacaine. From 1946 to 2017, only 16 studies comparing the clinical efficacy of isobaric and hyperbaric bupivacaine in nonpregnant patients have been conducted according to various databases. The small sample size and high heterogeneity of these results suggest that all results should be treated with caution. And, there is no conclusive evidence in favor of isobaric or hyperbaric bupivacaine regarding efficacy or side effects in the general surgical population.

The literature describes such advantages of levobupivacaine as less cardiotoxicity, longer period of analgesia, more pronounced activity against sensory fibers than against motor fibers. In some studies it has been shown that levobupivacaine is equal to isobaric bupivacaine in efficacy. The efficacy of hyperbaric levobupivacaine equivalent to hyperbaric bupivacaine when administered intrathecally has also been shown on volunteers.

However, in the literature there are different data on clinical efficacy of levobupivakin in comparison with ropivacaine and levobupivacaine. So during operations on extremities out of 20 patients surgical anesthesia developed in 18 patients. Fattorini F. et al. D in their study stated the same effectiveness of bupivacaine and levobupivacaine, but when using levobupivacaine in one patient general anesthesia was used due to insufficient spinal anesthesia. Other studies also reported similar efficacy of the two drugs, but surgical satisfaction with intraoperative anesthesia was 92.9% for bupivacaine and 83.9% for levobupivacaine for knee arthoroscopy.

In their study, P Gautier et al. noted significantly lower efficacy of levobupivacaine in caesarean section compared to bupivacaine and ropivacaine for intrathecal use: 80% vs. 90% and 87%, respectively.

According to Heng Sia et al. there is no clear evidence of the advantage of hyperbaric bupivacaine over isobaric bupivacaine for spinal anesthesia for cesarean section. The authors also noted that adequate randomized clinical trials with clear definitions, criteria and methodology for evaluating the transition to general anesthesia, requirements for additional analgesia, nausea, vomiting and sensory testing are needed.

There is no clear practical guide to help anesthesiologists make informed decisions about the use of some form of intrathecal bupivacaine in non-cesarean surgery. Carefully designed, adequately conducted studies can provide further results that will contribute to sound clinical decision making.

Given the above, the aim of the study is to compare the effectiveness of spinal anesthesia (SA) performed with 0.5% isobaric bupivacaine solution, 0.5% levobupivacaine solution and 0.5% hyperbaric bupivacaine solution in equivalent volumes in lower limb surgeries.

Conditions

• Anesthesia, Spinal

Interventions

PROCEDURE

spinal anesthesia

The anesthesiologist, who was not involved in the study, prepared the anesthetic solution immediately before the injection. Intrathecal injections were performed with a 24G or 25G "Pencil point" needle in the L3-L4 interval. Spinal puncture was performed while the patient was sitting on the table. Then the patient was placed on his back.

Sponsors & Collaborators

• Mogilev Regional Clinical Hospital

  lead OTHER_GOV

Principal Investigators

• Valery Piacherski · Mogilev Regional Clinical Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-18

Primary Completion

2022-01-06

Completion

2022-01-06

Countries

• Belarus

Study Locations