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

NCT05184465 | Completed

• 1 other identifier: 28.01.2017
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Spinal

Keywords

Bupivacaine; Levobupivacaine; Hyperbaric bupivacaine; Anesthesia Spinal; Аnesthetics Local

Outcome Measures

Primary Outcomes (1)

• Effectiveness of anesthesia

  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).

  Intraoperative

Secondary Outcomes (6)

• 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

• 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

• Duration of analgesia, (min)

  Postoperative period (within 24 hours)

Study Arms (3)

Bupivacaine

EXPERIMENTAL

Spinal anesthesia was administered to the patients for anesthetic support of the surgical intervention.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.Spinal anesthesia was performed with 3 ml of 0.5% bupivacaine. Then the patient was placed on his back.Surgery was allowed to start after 40 minutes if the upper level of the sensory block reached the Th10 segment.

Procedure: spinal anesthesia

Levobupivacaine

EXPERIMENTAL

Spinal anesthesia was administered to the patients for anesthetic support of the surgical intervention.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.Spinal anesthesia was performed with 3 ml of 0.5% Levobupivacaine. Then the patient was placed on his back.Surgery was allowed to start after 40 minutes if the upper level of the sensory block reached the Th10 segment.

Procedure: spinal anesthesia

Hyperbaric bupivacaine

EXPERIMENTAL

Spinal anesthesia was administered to the patients for anesthetic support of the surgical intervention.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.Spinal anesthesia was performed with 3 ml of 0.5% Hyperbaric bupivacaine. Then the patient was placed on his back.Surgery was allowed to start after 40 minutes if the upper level of the sensory block reached the Th10 segment.

Procedure: spinal anesthesia

Interventions

spinal anesthesia PROCEDURE

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.

Bupivacaine; Hyperbaric bupivacaine; Levobupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mogilev Regional Clinical Hospital: lead

Study Sites (1)

Mogilev Regional Clinical Hospital

Mogilev, 212026, Belarus

Location

Related Publications (13)

• Uppal V, Retter S, Shanthanna H, Prabhakar C, McKeen DM. Hyperbaric Versus Isobaric Bupivacaine for Spinal Anesthesia: Systematic Review and Meta-analysis for Adult Patients Undergoing Noncesarean Delivery Surgery. Anesth Analg. 2017 Nov;125(5):1627-1637. doi: 10.1213/ANE.0000000000002254.

  PMID: 28708665 BACKGROUND

• Foster RH, Markham A. Levobupivacaine: a review of its pharmacology and use as a local anaesthetic. Drugs. 2000 Mar;59(3):551-79. doi: 10.2165/00003495-200059030-00013.

  PMID: 10776835 BACKGROUND

• del-Rio-Vellosillo M, Garcia-Medina JJ, Abengochea-Cotaina A, Pinazo-Duran MD, Barbera-Alacreu M. Spinal anesthesia for knee arthroscopy using isobaric bupivacaine and levobupivacaine: anesthetic and neuroophthalmological assessment. Biomed Res Int. 2014;2014:349034. doi: 10.1155/2014/349034. Epub 2014 Feb 20.

  PMID: 24701571 BACKGROUND

• Glaser C, Marhofer P, Zimpfer G, Heinz MT, Sitzwohl C, Kapral S, Schindler I. Levobupivacaine versus racemic bupivacaine for spinal anesthesia. Anesth Analg. 2002 Jan;94(1):194-8, table of contents. doi: 10.1097/00000539-200201000-00037.

  PMID: 11772827 BACKGROUND

• Alley EA, Kopacz DJ, McDonald SB, Liu SS. Hyperbaric spinal levobupivacaine: a comparison to racemic bupivacaine in volunteers. Anesth Analg. 2002 Jan;94(1):188-93, table of contents. doi: 10.1097/00000539-200201000-00036.

  PMID: 11772826 BACKGROUND

• Burke D, Kennedy S, Bannister J. Spinal anesthesia with 0.5% S(-)-bupivacaine for elective lower limb surgery. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):519-23. doi: 10.1016/s1098-7339(99)90042-1.

  PMID: 10588555 BACKGROUND

• Fattorini F, Ricci Z, Rocco A, Romano R, Pascarella MA, Pinto G. Levobupivacaine versus racemic bupivacaine for spinal anaesthesia in orthopaedic major surgery. Minerva Anestesiol. 2006 Jul-Aug;72(7-8):637-44. English, Italian.

  PMID: 16865082 BACKGROUND

• Gautier P, De Kock M, Huberty L, Demir T, Izydorczic M, Vanderick B. Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section. Br J Anaesth. 2003 Nov;91(5):684-9. doi: 10.1093/bja/aeg251.

  PMID: 14570791 BACKGROUND

• Heng Sia AT, Tan KH, Sng BL, Lim Y, Chan ESY, Siddiqui FJ. Hyperbaric versus plain bupivacaine for spinal anesthesia for cesarean delivery. Anesth Analg. 2015 Jan;120(1):132-140. doi: 10.1213/ANE.0000000000000443.

  PMID: 25625258 BACKGROUND

• Sng BL, Siddiqui FJ, Leong WL, Assam PN, Chan ES, Tan KH, Sia AT. Hyperbaric versus isobaric bupivacaine for spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2016 Sep 15;9(9):CD005143. doi: 10.1002/14651858.CD005143.pub3.

  PMID: 27629425 BACKGROUND

• Vernhiet J, Cheruy D, Maindivide J, Vabre M, Clement C, Dartigues JF. [Spinal anesthesia with bupivacaine. Comparative study of 2 hyperbaric and isobaric solutions]. Ann Fr Anesth Reanim. 1984;3(4):252-5. doi: 10.1016/s0750-7658(84)80115-x. French.

  PMID: 6476498 BACKGROUND

• Singh A, Gupta A, Datta PK, Pandey M. Intrathecal levobupivacaine versus bupivacaine for inguinal hernia surgery: a randomized controlled trial. Korean J Anesthesiol. 2018 Jun;71(3):220-225. doi: 10.4097/kja.d.18.27191. Epub 2018 Apr 24.

  PMID: 29684982 BACKGROUND

• Piacherski V, Muzyka L. Comparison of the efficacy of 0.5% isobaric bupivacaine, 0.5% levobupivacaine, and 0.5% hyperbaric bupivacaine for spinal anesthesia in lower limb surgeries. Sci Rep. 2023 Feb 15;13(1):2736. doi: 10.1038/s41598-023-29711-9.

  PMID: 36792639 DERIVED

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Valery Piacherski

  Mogilev Regional Clinical Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 11, 2022
• Study Start: December 18, 2017
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data can be provided after the publication of the results of our study in a scientific medical journal.
• Access Criteria: Apply to the e-mail address to the authors: pechersky.v@yandex.ru

Locations

BE (1)