Skip to content

To find out the optimal dose of local anaesthesia drug required for spinal anaesthesia in laparoscopic cholecystectomy

To evaluate the optimal dose of isobaric levobupivacaine 0.5% with fentanyl as adjuvant for segmental spinal block in patients undergoing laparoscopic cholecystectomy - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074702
Enrollment
120
Registered
2024-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system

Interventions

Intervention1: Group A: Group A will receive 1ml of 0.5% isobaric levobupivacaine with 25 mcg fentanyl as adjuvant as drug for segmental spinal anaesthesia Control Intervention1: Group B: Group B will

Sponsors

Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients posted for elective laparoscopic cholecystectomy of expected duration less than 90 minutes, of either sex, in the age group of 18-50 years and American Society of Anaesthesiologists (ASA) grade I and II will be included in the study.

Exclusion criteria

Exclusion criteria: Patient refusal for participating in the study. ASA Grade III and IV patients. Patients with active cholecystitis. Patients with coagulopathy. Patients with BMI more than 35 kg per m2. Spinal deformity or previous spine surgery. Any other contraindication to central neuraxial blockade or thoracic segmental spinal anesthesia. Patients allergic to the study drugs. Requiring more than 3 attempts for the procedure.

Design outcomes

Primary

MeasureTime frame
Dose of isobaric levobupivacaine 0.5% with fentanyl as adjuvant which is required for laparoscopic cholecystectomyTimepoint: 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90 AND 120 MINUTES

Secondary

MeasureTime frame
Dermatomal mapping at onset of anaesthesia. Dermatomal regression at 30 minutes, 60 minutes, 90 minutes and 120 minutes. Surgeon comfortability score using Likhert scale. Timepoint: 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90 AND 120 MINUTES

Countries

India

Contacts

Public ContactAmrita Rath

Institute of Medical Sciences BHU

bhuapsingh@gmail.com9839412975

Outcome results

None listed

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