Epidural Dosage of Lidocaine Bupivacaine in Lower Limb SurgeriesLBM-LLSNCT07648784
Comparison of Different Epidural Lidocaine-Bupivacaine Mixtures for Lower Limb Surgeries
A study testing Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine) in people with Epidural Dosage of Lidocaine Bupivacaine in Lower Limb Surgeries, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Epidural Dosage of Lidocaine Bupivacaine in Lower Limb Surgeries
- What is being tested?
- Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Dec 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shaheed Mohtarma Benazir Bhutto Institute of Trauma
Karachi, Sindh, 75290
Tooba Azfar Hussain, MBBS, 03357192306, toobster1996@gmail.com
toobster1996@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)
- Keywords
- Epidural, Lidocaine, Bupivacaine, lower limb surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)Drug
Also called Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine), Bupivacaine Epidural Mixture (Control)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Time from completion of epidural injection until the patient develops Bromage Grade II motor blockade, measured in minutes.
Measured: From completion of epidural injection until achievement of Bromage Grade II motor blockade, assessed up to 20 minutes.
Duration of Motor Blockade
Time from achievement of Bromage Grade II motor blockade until complete recovery of motor function (Bromage Grade 0), measured in minutes.
Measured: 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
Mean arterial pressure will be recorded every 3 minutes for the first 30 minutes and then every 5 minutes until completion of surgery.
Measured: From epidural injection until completion of surgery, assessed up to 3 hours.
Heart Rate
Heart rate will be continuously monitored throughout the procedure and recorded at predefined intervals during surgery.
Measured: From epidural injection until completion of surgery, assessed up to 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start18 Dec 2025
- Primary completion20 May 2026
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Dosage of Lidocaine Bupivacaine in Lower Limb SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tooba Azfar Hussain, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648784
- Sponsor's protocol ID
- THussain
- Other IDs
- SMBBIT
- Acronym
- LBM-LLS
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Outcomes of Epidural Injection of Different Lidocaine-Bupivacaine Mixtures for Lower Limb Surgeries at a Tertiary Care Hospital, Karachi
- ClinicalTrials.gov ID
- NCT07648784
- Acronym / sponsor ID
- LBM-LLS / THussain
- Keywords
- Epidural, Lidocaine, Bupivacaine, lower limb surgeries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A - High-dose Lidocaine-Bupivacaine Mixture | Experimental | Drug: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)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). |
| Group B - Low-dose Lidocaine-Bupivacaine Mixture | Experimental | Drug: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)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). |
| Group C - Bupivacaine Control Group | Active comparator | Drug: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)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). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)Also: Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine), Bupivacaine Epidural Mixture (Control)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. | Drug | Group A - High-dose Lidocaine-Bupivacaine Mixture, Group B - Low-dose Lidocaine-Bupivacaine Mixture, Group C - Bupivacaine Control Group |
Primary outcome
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.
4 secondary outcomes
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.
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.
Mean Arterial Pressure
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine) in people with Epidural Dosage of Lidocaine Bupivacaine in Lower Limb Surgeries, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tooba Azfar Hussain, MBBS (03357192306, toobster1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.