Comparison of drug Bupivacaine alone with Bupivacaine and Midazolam given in spinal analgesia for operations in lower half of body.

Comparison of intrathecal Bupivacaine and Bupivacaine plus Midazolam in spinal analgesia. - Bupivacaine, Midazolam, Spinal analgesia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/017322

Enrollment

100

Registered

2019-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: R50-R69- General symptoms and signs

Interventions

Intervention1: Midazolam & Bupivacaine intrathecal,Normal Saline & Bupivacaine intrathecal in spinal space: Patients in one group B will receive 3.0 ml of Bupivacaine heavy 0.5% and 0.4 ml of normal

Eligibility

Inclusion criteria

Inclusion criteria: Total 100 patients of ASA Grade I and II between the age group of 25 to 50 years of age undergoing surgery below umbilicus under spinal analgesia will be taken.

Exclusion criteria

Exclusion criteria: Patients with H/O long-term uncontrolled hypertension, uncontrolled DM cases, known neurologic or psychological disorders, spinal column surgery, with low back pain, chronic alcoholism, opium addiction or on any drug that modifies pain will not be included in this study. Patient with coagulation abnormality, patient with infection at the site of injection will also be excluded

Design outcomes

Primary

Measure	Time frame
After lumber puncture drugs will be injected.Patients will be positioned supine at Highest dermatome sensory block level will be assessed.Time of regression of sensory & motor block will be noted.Time for recovery of motor blockade to L 2 (hip flexion) will be noted.Time of first rescue analgesia will be noted. The patients will also be observed for any side effect;and treated if appeared. Timepoint: After lumber puncture drugs will be injected over period of 15 seconds. Patients will be positioned supine at least 20 minutes. Highest dermatome sensory block level will be assessed.Vitals of patients will be monitored during surgery. Time for four segment regression of sensory blockade will be noted.Time for recovery of motor blockade to L 2 (hip flexion) will be noted.Time of first rescue analgesia will be noted.Patients will be observed for side effects and treated.	—

Measure

Time frame

After lumber puncture drugs will be injected.Patients will be positioned supine at Highest dermatome sensory block level will be assessed.Time of regression of sensory & motor block will be noted.Time for recovery of motor blockade to L 2 (hip flexion) will be noted.Time of first rescue analgesia will be noted. The patients will also be observed for any side effect;and treated if appeared. Timepoint: After lumber puncture drugs will be injected over period of 15 seconds. Patients will be positioned supine at least 20 minutes. Highest dermatome sensory block level will be assessed.Vitals of patients will be monitored during surgery. Time for four segment regression of sensory blockade will be noted.Time for recovery of motor blockade to L 2 (hip flexion) will be noted.Time of first rescue analgesia will be noted.Patients will be observed for side effects and treated.

—

Secondary

Measure	Time frame
The block produced by drug combinations injected will be studiedTimepoint: The duration and quality of block and side effects if any will be studied intaopertively & post operatively	—

Countries

India

Contacts

Public ContactDr Kanhaiya Lal Kishnani

Peoples college of Medical Sciences & R C Bhanpur Bhopal

drkishnani@gmail.com07554004010

Outcome results

None listed

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