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Clinical Trials/NCT05184465
NCT05184465CompletedNot Applicable

Comparison of the Efficacy of 0.5% Bupivacaine, 0.5% Levobupivacaine, and 0.5% Hyperbaric Bupivacaine in Equal Volumes for Spinal Anesthesia in Lower Limb Surgeries

Mogilev Regional Clinical Hospital2 sites in 1 country111 target enrollmentStarted: December 18, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
111
Locations
2
Primary Endpoint
Effectiveness of anesthesia

Study Overview

Brief 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.

Detailed Description

111patients who underwent surgical intervention on the hip, thigh, and knee joints were included in the study.

Criteria for inclusion of patients in the study: indications for surgical intervention on the hip, thigh, and knee joints. Anesthesiological support was required; a written informed consent was obtained from patients to participate in the clinical trial and a written informed consent of the patient about the type of anesthesia and possible complications of regional anesthesia was available. After obtaining informed consent, patients were randomized into groups using a random number generator (numbers in envelopes). The random assignment sequence was created by an anesthesiologist not involved in the study.

Exclusion criteria: patient refusal to use the proposed type of anesthesia, age <18 years, body mass index not > 39, physical status according to ASA 1-3, history of allergic reactions to the drugs used, coagulopathy, infectious skin lesions in the injection area, neurological or neuromuscular diseases, severe liver disease or renal failure, inability to cooperate with the patient.

Spinal anesthesia was administered to the patients for anesthetic support of the surgical intervention. Patients were randomly allocated into three groups: in group 1 (1B) spinal anesthesia was performed with 3 ml of 0.5% bupivacaine(n=37); in group 2 (2L) spinal anesthesia was performed with 3 ml of 0.5% levobupivacaine (n=37); in group 3 (3H) 3 ml of 0.5% hyperbaric bupivacaine solution (n=37) was used for subarachnoid injection. 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • indications for surgical intervention on the hip, thigh, and knee joints

Exclusion Criteria

  • patient refusal to use the proposed type of anesthesia,
  • age <18 years,
  • body mass index not > 39,
  • physical status according to ASA 1-3,
  • history of allergic reactions to the drugs used,
  • coagulopathy,
  • infectious skin lesions in the injection area,
  • neurological or neuromuscular diseases,
  • severe liver disease or renal failure,
  • inability to cooperate with the patient.

Outcomes

Primary Outcomes

Effectiveness of anesthesia

Time Frame: Intraoperative

The criterion for assessing the effectiveness of anesthesia was the need to switch to another type of anesthesia (criterion-no anesthesia), or the need for additional use of narcotic analgesics or local anesthesia during surgery (criterion-reporting of painful feelings during the operation).

Secondary Outcomes

  • Time to develop a complete sensory block, (min)(Skin sensitivity was assessed every 2 minutes for 40 minutes)
  • Time of development of the full motor block, (min)(Motor block was assessed every 2 minutes for 40 minutes)
  • Complete sensory block(Skin sensitivity was assessed every 2 minutes for 40 minutes)
  • Complete motor block(Motor block was assessed every 2 minutes for 40 minutes)
  • Duration of motor block, (min)(Postoperative period (within 24 hours))
  • Duration of analgesia, (min)(Postoperative period (within 24 hours))

Investigators

Sponsor
Mogilev Regional Clinical Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Valery Piacherski, Ph.D.

Chief of the Department of Anesthesiology and Intensive Care

Mogilev Regional Clinical Hospital

Study Sites (2)

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