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Comparison of hyperbaric solutions of bupivacaine, levobupivacaine and ropivacaine in spinal anaesthesia for elective surgery: a prospective randomised double-blind study

Comparison of hyperbaric solutions of Bupivacaine, Levobupivacaine and Ropivacaine in Spinal anaesthesia for elective surgery: A prospective, Randomised, double-blind study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089006
Enrollment
75
Registered
2025-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K612- Anorectal abscess Health Condition 2: N819- Female genital prolapse, unspecified Health Condition 3: N979- Female infertility, unspecified Health Condition 4: N433- Hydrocele, unspecified Health Condition 5: O- Medical and Surgical Health Condition 6: O- Medical and Surgical Health Condition 7: O021- Missed abortion Health Condition 8: K36- Other appendicitis Health Condition 9: N849- Polyp of female genital tract, unspecified Health Condition 10: N434- Spermatocele of

Interventions

Intervention1: Hyperbaric Bupivacaine: administeration of spinal anesthesia drug in consenting patients
0.5% Hyperbaric Bupivacaine intrathecally
for duration of surgery Control Intervention1: Hyperbaric Levobupivacaine: administeration of spinal anesthesia drug in consenting patients
0.5% Hyperbaric Levobupivacaine intrathecally
for duration of surgery Control Intervention2: Hyperbaric Ropivacaine: administeration of spinal anesthesia drug in consenting patients
for duration of surgery

Sponsors

HBTMC and Dr RN Cooper hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and II

Exclusion criteria

Exclusion criteria: ASA III and IV Blood Dyscrasias Clotting disorders Pregnant and Lactating History of hypersensitivity disorders Pain modifying drugs

Design outcomes

Primary

MeasureTime frame
Onset and duration of sensory blockade with the three drugs Timepoint: assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure; post procedure assesment done evry 30 min till level recedes completely

Secondary

MeasureTime frame
1.Onset & duration of motor blockade 2. Effect on heart rate 3. Effect on MAP 4. Effect on PONV Timepoint: 1. assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure; post procedure assesment done evry 30 min till level recedes completely 2. assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure. 3. assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure. 4. Intra operative & post operative till 24 hours

Countries

India

Contacts

Public ContactAishani Chawla

H.B.T.M.C and Dr R.N. Cooper hospital, Mumbai

drnaina@rediffmail.com7795362668

Outcome results

None listed

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