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Comparison of two local anaesthetic agents in modified spinal anaesthesia for laparoscopic gall bladder surgery

Thoracic segmental spinal anaesthesia in laparoscopic cholecystectomy: A prospective comparative study of Isobaric Ropivacaine vs. Isobaric Levobupivacaine - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089713
Enrollment
40
Registered
2025-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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 Ropivacaine: A thorough pre-anesthetic evaluation will be done including spine assessment, airway assessment and necessary laboratory investigations. All patients will be kept

Sponsors

GMERS Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients undergoing elective laparoscopic cholecystectomy surgery ASA I and II patients Mouth opening greater than 3 fingers MPG grade 1 and 2 BMI range 19-27 kg/m2

Exclusion criteria

Exclusion criteria: Patient s refusal Contraindications for spinal anaesthesia Anticipated difficult intubation Pregnancy Known allergy to study drugs

Design outcomes

Primary

MeasureTime frame
To compare sensory block duration of Isobaric Ropivacaine vs Isobaric Levobupivacaine.Timepoint: Sensory block duration will be assessed from the time of intrathecal drug administration until regression of sensory block to T8 dermatome, with assessment at regular intervals: every 2 minutes for the fire 20 mins, every 5 minutes until 60 minutes, and then every 15 minutes until regression to T8

Secondary

MeasureTime frame
To assess Time to achieve T4 level in both drugs To assess hemodynamic stability of both drugs To assess patient & surgeon satisfaction score To compare incidence of adverse eventsTimepoint: Time to achieve T4 level: from completion of intrathecal injection up to level T4 is achieved (assessed clinically every 2 mins with tip of 24G needle) Hemodynamic stability: Baseline, then at 3,5,15,30 minutes & then after at every 10 minutes intraoperatively & postoperatively at 2 hours intervals for 6 hours Patient satisfaction score: At the end of surgery & again 6 hours post operatively Surgeon satisfaction score: immediately after completion of surgical procedure

Countries

India

Contacts

Public ContactDr Anup Chandnani

GMERS Medical College, Gotri, Vadodara

anupchandnani29@gmail.com9925436505

Outcome results

None listed

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