Comparison of Different Epidural Lidocaine-Bupivacaine Mixtures for Lower Limb Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorShaheed Mohtarma Benazir Bhutto Institue of Trauma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)
DrugIntervention 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.
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: Group A - High-dose Lidocaine-Bupivacaine MixtureExperimental treatment 1 intervention
Group B: Group B - Low-dose Lidocaine-Bupivacaine MixtureExperimental treatment 1 intervention
Group C: Group C - Bupivacaine Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
From completion of epidural injection until achievement of sensory block at the T10 dermatome level, assessed up to 20 minutes.Secondary outcomes
1
Time to Onset of Motor Blockade
Time from completion of epidural injection until the patient develops Bromage Grade II motor blockade, measured in minutes.
Time frame
From completion of epidural injection until achievement of Bromage Grade II motor blockade, assessed up to 20 minutes.2
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.
Time frame
From achievement of Bromage Grade II motor blockade until complete recovery of motor function, assessed up to 8 hours after epidural injection.3
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.
Time frame
From epidural injection until completion of surgery, assessed up to 3 hours.4
Heart Rate
Heart rate will be continuously monitored throughout the procedure and recorded at predefined intervals during surgery.
Time frame
From epidural injection until completion of surgery, assessed up to 3 hours.Sponsors and contacts
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Source ClinicalTrials.gov