To compare the effect of an anaesthesia technique using lesser volume of local anesthetics in old age patients undergoing lower limb surgeries.

Comparison of normal saline versus 1.5% lidocaine for epidural volume expansion following combined spinal epidural anesthesia with low dose intrathecal 0.5% hyperbaric bupivacaine for lower limb surgeries in elderly patients. -A prospective randomised double blinded study.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036564

Enrollment

Registered

2021-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: V899- Person injured in unspecified vehicle accident Health Condition 2: V029- Pedestrian injured in collision with two- or three-wheeled motor vehicle, unspecified whether traffic or nontraffic accident Health Condition 3: V299- Motorcycle rider (driver) (passenger) injured in unspecified traffic accident Health Condition 4: W19- Unspecified fall Health Condition 5: I119- Hypertensive heart disease withoutheart failure Health Condition 6: E119- Type 2 diabetes mellitus witho

Interventions

Intervention1: lidocaine: 10 ml of 1.5% lidocaine following the intrathecal injection of 10mg 0.5% hyperbaric bupivacaine Control Intervention1: normal saline: 10 ml of 0.9% normal saline following th

Eligibility

Inclusion criteria

Inclusion criteria: American society of anesthesiologist [ASA] physical status classification 1 and 2 Scheduled for elective lower limb surgery under regional anesthesia Patients with valid informed consent.

Exclusion criteria

Exclusion criteria: Intrinsic or idiopathic coagulopathy Skin or soft tissue infection at the proposed site of needle insertion Pre existing neurological diseases like lower extremity neuropathy Patients with spinal deformities Severe hypovolemia Emergency lower limb surgeries Patients with known allergy to study drug

Design outcomes

Primary

Measure	Time frame
Time required to achieve maximum motor blockade.Timepoint: Fifteen minutes	—

Secondary

Measure	Time frame
Level of maximum sensory block Two segment regression time of sensory block Time to recover from motor block The requirement of rescue analgesia Epidural top up requirements Hemodynamic changesTimepoint: Sensory block to loss of pain will be assessed immediately after spinal anaesthesia then at 5, 10, 15, 20 minutes intra operatively and then at 30, 60, 90, 120 minutes post operatively. Non invasive mean arterial blood pressure, heart rate, oxygen saturation, respiratory rate will be assessed every 5 minutes for the first 15 minutes and every 10 minutes thereafter until full recovery.	—

Measure

Time frame

Level of maximum sensory block Two segment regression time of sensory block Time to recover from motor block The requirement of rescue analgesia Epidural top up requirements Hemodynamic changesTimepoint: Sensory block to loss of pain will be assessed immediately after spinal anaesthesia then at 5, 10, 15, 20 minutes intra operatively and then at 30, 60, 90, 120 minutes post operatively. Non invasive mean arterial blood pressure, heart rate, oxygen saturation, respiratory rate will be assessed every 5 minutes for the first 15 minutes and every 10 minutes thereafter until full recovery.

—

Countries

India

Contacts

Public ContactDr Jyothi B

Karnataka institute of medical sciences

dr.jyothib1@gmail.com9886187056

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026