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comparison of 2 anaesthetic drugs in terms of their ability to reduce pain in operation below the umbilicus

Comparative study of the analgesic efficacy of 0.5% isobaric ropivacaine with 25 μg fentanyl vs 0.5% isobaric bupivacaine with 25 μg fentanyl intrathecally in elective infraumbilical surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/08/003877
Enrollment
74
Registered
2013-08-05
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- patients undergoing infraumbilical surgery

Interventions

Intervention1: Isobaric Ropivacaine with fentanyl: ropivacaine 0.5% 3 ml with 25 microgram fentanyl in subarachnoid route only once before beginning of surgery Control Intervention1: Isobaric Bupivaca

Sponsors

Institute of Post Graduate Medical Education Research Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Seventy four patients in the age group of 18 to 60 years of either sex and of ASA Physical Status I or II undergoing infraumbilical surgery under subarachnoid block

Exclusion criteria

Exclusion criteria: a) Patient refusal. b) ASA physical status grade III or IV c) Any contraindication to spinal anaesthesia â?? i. Infection at the site of injection ii. Coagulopathy iii. Neurological disorders iv. Stenotic heart diseases v. Spinal deformity vi. Haemodynamically compromised patients d) Known allergy to bupivacaine, ropivacaine or fentanyl. e) Patients on chronic analgesic therapy or antiplatelet drugs and anticoagulants. f) Pregnancy

Design outcomes

Primary

MeasureTime frame
comparison of duration of effective analgesia between the two study groupsTimepoint: comparison of duration of effective analgesia between the two study groups

Secondary

MeasureTime frame
1. perioperative haemodynamic changes 2. intraoperative sedation and any untoward side effects during the studyTimepoint: throughout the intraoperative period and postoperative period

Countries

India

Contacts

Public ContactDr Amitava Layek

Institute of Post Graduate Medical Education & Research, Kolkata

amitavalayek@gmail.com

Outcome results

None listed

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