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

June 12, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75290
        • Recruiting
        • Shaheed Mohtarma Benazir Bhutto Institute of Trauma
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tooba Azfar Hussain, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Drug: 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.

Other Names:
  • 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).
Drug: 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.

Other Names:
  • Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine)
  • Bupivacaine Epidural Mixture (Control)
Active Comparator: 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).
Drug: 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.

Other Names:
  • Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine)
  • Bupivacaine Epidural Mixture (Control)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Onset of Sensory Blockade
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Onset of Motor Blockade
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THussain
  • SMBBIT (Other Identifier: SMBBIT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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