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Comparison of Different Epidural Lidocaine-Bupivacaine Mixtures for Lower Limb Surgeries (LBM-LLS)

12. Juni 2026 aktualisiert von: Dr. Tooba Azfar Hussain, Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Comparison of the Outcomes of Epidural Injection of Different Lidocaine-Bupivacaine Mixtures for Lower Limb Surgeries at a Tertiary Care Hospital, Karachi

This randomized controlled trial will evaluate different epidural lidocaine-bupivacaine mixtures in patients undergoing lower limb surgery at a tertiary care hospital in Karachi, Pakistan. Ninety-six participants will be randomly assigned to one of three study groups receiving different combinations of lidocaine and bupivacaine for epidural anesthesia.

The purpose of this study is to determine which anesthetic mixture provides the most effective anesthesia for lower limb surgery. The study will compare the speed of onset and duration of anesthesia, as well as the effects of the anesthetic mixtures on cardiovascular stability during surgery.

The results of this study may help identify an epidural anesthetic regimen that provides optimal surgical conditions, effective pain control, and stable hemodynamic parameters for patients undergoing lower limb procedures.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Lower limb surgeries are commonly associated with significant perioperative and postoperative pain, requiring effective anesthetic techniques to provide adequate analgesia and improve patient outcomes. Epidural anesthesia is widely used because it offers effective intraoperative anesthesia, prolonged postoperative pain relief, improved physiological responses to surgical stress, and enhanced patient satisfaction. Local anesthetic agents such as lidocaine and bupivacaine are commonly administered for epidural blockade due to their different pharmacological characteristics.

Lidocaine has a rapid onset of action but a relatively shorter duration, whereas bupivacaine provides prolonged analgesia but has a slower onset of action. Combining these agents may provide the advantages of both drugs by achieving rapid onset with longer duration of action while maintaining hemodynamic stability.

This randomized controlled trial will be conducted at the Department of Anaesthesiology and Surgical ICU, Shaheed Mohtarma Benazir Bhutto Institute of Trauma, Karachi. Ninety-six patients aged 20-60 years, ASA class I and II, undergoing lower limb surgeries under epidural anesthesia will be enrolled and randomized equally into three groups.

Group A: 10 ml of 0.5% isobaric bupivacaine + 5 ml of 2% lidocaine Group B: 10 ml of 0.5% isobaric bupivacaine + 2.5 ml of 2% lidocaine + 2.5 ml normal saline Group C: 10 ml of 0.5% isobaric bupivacaine + 5 ml normal saline

The primary outcomes assessed will include time to onset of sensory blockade at T10 level, time to onset of motor blockade to Bromage Grade II, and duration of motor blockade until recovery to Bromage Grade I. Hemodynamic variables including mean arterial pressure and heart rate will also be recorded and compared among groups.

The study aims to determine the optimal epidural lidocaine-bupivacaine mixture that provides faster onset of anesthesia, adequate duration of block, and stable hemodynamic effects in patients undergoing lower limb surgeries.

Studientyp

Interventionell

Einschreibung (Geschätzt)

96

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75290
        • Rekrutierung
        • Shaheed Mohtarma Benazir Bhutto Institute of Trauma
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Tooba Azfar Hussain, MBBS

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

Patients undergoing lower limb surgeries under epidural block Age between 20-60 years Either gender American Society of Anesthesiologists (ASA) physical status I and II Patients willing to provide informed consent

Exclusion Criteria:

Contraindications to regional anesthesia including patient refusal and bleeding diathesis History of allergy to local anesthetics Patients undergoing emergency surgeries Deformities of the spine History of hypothyroidism or hyperthyroidism Pregnant patients

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group A - High-dose Lidocaine-Bupivacaine Mixture
Group A High-dose Lidocaine-Bupivacaine Mixture Participants will receive epidural administration of 10 ml of 0.5% isobaric bupivacaine mixed with 5 ml of 2% lidocaine (total volume 15 ml).
Arzneimittel: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)

Intervention 1: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine and 5 ml of 2% lidocaine for anesthesia during lower limb surgery.

Intervention 2: Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine, 2.5 ml of 2% lidocaine, and 2.5 ml of normal saline for anesthesia during lower limb surgery.

Intervention 3: Bupivacaine Epidural Mixture (Control) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine and 5 ml of normal saline for anesthesia during lower limb surgery.

These descriptions clearly distinguish the three interventions by composition and total volume.

Andere Namen:
  • Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine)
  • Bupivacaine Epidural Mixture (Control)
Experimental: Group B - Low-dose Lidocaine-Bupivacaine Mixture
Group B - Low-dose Lidocaine-Bupivacaine Mixture Participants will receive epidural administration of 10 ml of 0.5% isobaric bupivacaine mixed with 2.5 ml of 2% lidocaine and 2.5 ml normal saline (total volume 15 ml).
Arzneimittel: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)

Intervention 1: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine and 5 ml of 2% lidocaine for anesthesia during lower limb surgery.

Intervention 2: Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine, 2.5 ml of 2% lidocaine, and 2.5 ml of normal saline for anesthesia during lower limb surgery.

Intervention 3: Bupivacaine Epidural Mixture (Control) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine and 5 ml of normal saline for anesthesia during lower limb surgery.

These descriptions clearly distinguish the three interventions by composition and total volume.

Andere Namen:
  • Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine)
  • Bupivacaine Epidural Mixture (Control)
Aktiver Komparator: Group C - Bupivacaine Control Group
Group C Participants will receive epidural administration of 10 ml of 0.5% isobaric bupivacaine mixed with 5 ml normal saline (total volume 15 ml).
Arzneimittel: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)

Intervention 1: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine and 5 ml of 2% lidocaine for anesthesia during lower limb surgery.

Intervention 2: Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine, 2.5 ml of 2% lidocaine, and 2.5 ml of normal saline for anesthesia during lower limb surgery.

Intervention 3: Bupivacaine Epidural Mixture (Control) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine and 5 ml of normal saline for anesthesia during lower limb surgery.

These descriptions clearly distinguish the three interventions by composition and total volume.

Andere Namen:
  • Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine)
  • Bupivacaine Epidural Mixture (Control)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to Onset of Sensory Blockade
Zeitfenster: From completion of epidural injection until achievement of sensory block at the T10 dermatome level, assessed up to 20 minutes.
Time from completion of epidural injection until development of sensory block at the T10 dermatome level, measured in minutes using the cold swab test.
From completion of epidural injection until achievement of sensory block at the T10 dermatome level, assessed up to 20 minutes.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to Onset of Motor Blockade
Zeitfenster: From completion of epidural injection until achievement of Bromage Grade II motor blockade, assessed up to 20 minutes.
Time from completion of epidural injection until the patient develops Bromage Grade II motor blockade, measured in minutes.
From completion of epidural injection until achievement of Bromage Grade II motor blockade, assessed up to 20 minutes.
Duration of Motor Blockade
Zeitfenster: From achievement of Bromage Grade II motor blockade until complete recovery of motor function, assessed up to 8 hours after epidural injection.
Time from achievement of Bromage Grade II motor blockade until complete recovery of motor function (Bromage Grade 0), measured in minutes.
From achievement of Bromage Grade II motor blockade until complete recovery of motor function, assessed up to 8 hours after epidural injection.
Mean Arterial Pressure
Zeitfenster: From epidural injection until completion of surgery, assessed up to 3 hours.
Mean arterial pressure will be recorded every 3 minutes for the first 30 minutes and then every 5 minutes until completion of surgery.
From epidural injection until completion of surgery, assessed up to 3 hours.
Heart Rate
Zeitfenster: From epidural injection until completion of surgery, assessed up to 3 hours.
Heart rate will be continuously monitored throughout the procedure and recorded at predefined intervals during surgery.
From epidural injection until completion of surgery, assessed up to 3 hours.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Dezember 2025

Primärer Abschluss (Tatsächlich)

20. Mai 2026

Studienabschluss (Geschätzt)

15. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

7. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juni 2026

Zuerst gepostet (Tatsächlich)

15. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juni 2026

Zuletzt verifiziert

1. Dezember 2025

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • THussain
  • SMBBIT (Andere Kennung: SMBBIT)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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