A study to compare the post operative analgesic effect of the two group of study drugs in spine surgery patients

A comparison of Gelfoam soaked in Isobaric Levobupivacaine 0.5% versus Isobaric Levobupivacaine 0.5% and Dexmedetomidine 25 mcg for post operative analgesia in spine surgeries: A Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068303

Enrollment

Registered

2024-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: ISOBARIC LEVOBUPIVACAINE 0.5%: Dose- 10 ml of isobaric Levobupivacaine 0.5% Route- As gelfoam placed in the epidural space Frequency- Once at the time of closure of incision Control I

Eligibility

Inclusion criteria

Inclusion criteria: ASA grading I, II Patients scheduled to undergo single level or bilevel spine surgeries under GA

Exclusion criteria

Exclusion criteria: Severe cardiac and lung diseases Psychological disorder History of allergic reactions to drugs under study Patient refusal to give consent

Design outcomes

Primary

Measure	Time frame
To measure and compare the vas score of different study drug combinations used during epidural anaesthesiaTimepoint: At 0 hr(immediately after extubation), 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 18 hours, 24 hours	—

Secondary

Measure	Time frame
To measure the total analgesic requirement and determine the time of rescue analgesia and to determine the hemodynamic parameters of study participantsTimepoint: Over 24 hrs	—

Countries

India

Contacts

Public ContactAishwarya G Nair

Mahatma Gandhi Memorial Medical College, Indore, M.P

rravistiffler@gmail.com7389012851

Outcome results

None listed

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