Comparison of Different Epidural Lidocaine-Bupivacaine Mixtures for Lower Limb Surgeries

NCT07648784 | Recruiting DMC

• 2 other identifiers: THussainSMBBIT
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epidural Dosage of Lidocaine Bupivacaine in Lower Limb Surgeries

Keywords

Epidural, Lidocaine, Bupivacaine, lower limb surgeries

Outcome Measures

Primary Outcomes (1)

• Time to Onset of Sensory Blockade

  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 Outcomes (4)

• Time to Onset of Motor Blockade

  From completion of epidural injection until achievement of Bromage Grade II motor blockade, assessed up to 20 minutes.

• Duration of Motor Blockade

  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

  From epidural injection until completion of surgery, assessed up to 3 hours.

• Heart Rate

  From epidural injection until completion of surgery, assessed up to 3 hours.

Study Arms (3)

Group A - High-dose Lidocaine-Bupivacaine Mixture

EXPERIMENTAL

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)

Group B - Low-dose Lidocaine-Bupivacaine Mixture

EXPERIMENTAL

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)

Group C - Bupivacaine Control Group

ACTIVE COMPARATOR

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)

Interventions

Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine) DRUG

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.

Also known as: Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine), Bupivacaine Epidural Mixture (Control)

Group A - High-dose Lidocaine-Bupivacaine Mixture; Group B - Low-dose Lidocaine-Bupivacaine Mixture; Group C - Bupivacaine Control Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaheed Mohtarma Benazir Bhutto Institue of Trauma: lead

Study Sites (1)

Shaheed Mohtarma Benazir Bhutto Institute of Trauma

Karachi, Sindh, 75290, Pakistan

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Tooba Azfar Hussain, MBBS

CONTACT

03357192306; toobster1996@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: thussain

Model Details: Participants will be randomly allocated into three parallel groups using sealed envelope randomization. Group A will receive 10 ml of 0.5% isobaric bupivacaine with 5 ml of 2% lidocaine, Group B will receive 10 ml of 0.5% isobaric bupivacaine with 2.5 ml of 2% lidocaine and 2.5 ml normal saline, and Group C will receive 10 ml of 0.5% isobaric bupivacaine with 5 ml normal saline. Outcomes including sensory blockade, motor blockade, and hemodynamic parameters will be compared among the three groups.

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 15, 2026
• Study Start: December 18, 2025
• Primary Completion: May 20, 2026
• Study Completion: June 15, 2026
• Last Updated: June 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)