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To compare two pain killer drugs delivered regionally before surgery around lower back on the anaesthetic agent usage and pain relief in patients undergoing spine surgeries under General Anaesthesia

Comparison of effects of pre-emptive caudal Ropivacaine and Levobupivacaine on isoflurane consumption and analgesic requirements in lumbosacral spine surgeries: A double-blind, randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013528
Enrollment
50
Registered
2018-04-27
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: null- ASA 1 and 2 patients undergoing lumbosacral spine surgeries Health Condition 2: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Ropivacaine: 25 ml of 0.2% Ropivacaine single shot in the caudal space after patient is put prone for surgery(20 minutes prior to skin incision) Control Intervention1: Levobupivacaine:

Sponsors

Self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients who give written informed consent 2) ASA 1 and 2 patients 3) Aged between 18 to 50 years 4) Body Mass Index 18.9 to 24.9 kg/m2

Exclusion criteria

Exclusion criteria: 1) Patient refusal 2) Patients with systemic illnesses 3) Patients with sacral anomaly or undergone previous spine surgery or those with pre existing neurological deficits 4) Patients with drug allergies 5) Patients with contraindication for neuraxial techniques

Design outcomes

Primary

MeasureTime frame
1) Isoflurane consumption intraoperatively 2) Duration and quality of analgesiaTimepoint: 1) Isoflurane consumption noted every half an hour intraoperatively and total consumption at the end of surgery 2) Duration and quality of analgesia postoperatively every half hourly till patient demands additional analgesic or visual analogue score is more than 4

Secondary

MeasureTime frame
To assess safety profile of Ropivacaine and LevobupivacaineTimepoint: Throughout during study period

Countries

India

Contacts

Public ContactDr Swathi N

Bangalore Medical College and Research Institute

swathisaggi@gmail.com9972454989

Outcome results

None listed

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