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A study was undertaken to see the spinal anaesthesia consequences in patients undergoing surgeries below navel region while using the local anaesthetics like levobupivacaine, bupivacaine and ropivacaine along with an additive nalbuphine

A prospective randomized study comparing the effects of intrathecal hyperbaric levobupivacaine, bupivacaine and ropivacaine using nalbuphine as an adjuvant in elective infraumbilical surgeries - Not applicable

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051813
Enrollment
120
Registered
2023-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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: Levobupivacaine, Bupivacaine and Ropivacaine with Nalbuphine: Group BN received 0.5% bupivacaine heavy 3.2ml with 0.6mg nalbuphine (0.3ml), Group LN received 0.5% levobupivaaine heavy

Sponsors

PSG Institute of medical sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients acceptance, Patients aged between 20 and 50 years, ASA status 1 and 2 patients and Patients undergoing elective infra umbilical surgeries under spinal anesthesia.

Exclusion criteria

Exclusion criteria: Absolute contraindication for spinal anesthesia, Combined spinal-epidural anesthesia, Known hypersensitivity or allergy to the study drugs, Pregnancy and lactating mothers

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to compare the duration of motor blockade of hyperbaric levobupivacaine, bupivacaine and ropivacaine with nalbuphine adjuvant.Timepoint: 1, 3, 5, 10, 15, 30, 60, 90, 120, 180, 240 and 300 minutes

Secondary

MeasureTime frame
The secondary objective focusses on the 1.Duration of sensory blockade 2.Effect of drugs on intraoperative haemodynamics 3.Time of regression of spinal anaesthesia 4.Side effects and complications of the hyperbaric levobupivacaine, bupivacaine and ropivacaine with nalbuphine as an adjuvant.Timepoint: 1, 3, 5, 10, 15, 30, 60, 90, 120, 180, 240 and 300 minutes

Countries

India

Contacts

Public ContactG Nimi

PSG IMSR

shivaaniarun76@gmail.com9944113440

Outcome results

None listed

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