To compare the effect of two local anaesthetic Ropivacaine versus Bupivacaine used in spinal anaesthesia for operation of lower abdomen .

Phase 4

Not yet recruiting

• Conditions: ASA 1 and 2; Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2024/01/062018
• Lead Sponsor: ESIC CORPORATION

Brief Summary

The use of neuraxial anaesthesia has dramatically increased since 1997. Attenuation of Intraoperative anxiety and stress always remains a challenge in the practice of anaesthesia and it also has several detrimental effects on different systems of human body .Neuraxial anaesthesia techniques have several advantages ,including a decreased risk of failed intubation and aspiration of gastric contents, avoidance of depressant agents, decreased blood loss, ability  of remaining awake.

Hyperbaric bupivacaine is recommended because of its reliability of spread to the mid thoracic level and appropriate duration of action. Hyperbaric L.A descend downward when sitting and toward T4 when supine.

Ropivacaine, a local anaesthetic with duration of action of 2-3 hours, has shown greater selectivity for sensory blockade along with lower systemic toxicity as compared to bupivacaine when used for spinal anaesthesia. -

The purpose of our study was to compare effectiveness , the level of adequate block both sensory and motor  with haemodynamic stability in patients undergoing spinal anaesthesia for lower abdominal surgery with intrathecal hyperbaric Ropivacaine and hyperbaric Bupivacaine.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-01-27
• Study Start: 2024-02-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Patient who gives consent ASA Grade 1 and 2 Age:18-65 years Any patient posted for elective lower abdominal procedure to be done under sub arachnoid block.

Exclusion Criteria

Patient who does not give consent Any contraindication to sub arachnoid block Patients undergoing caesarean section Expected duration of surgery more than 2 hrs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effectiveness of intrathecal hyperbaric Bupivacaine versus Ropivacaine in elective lower abdominal procedures	3 hours

Secondary Outcome Measures

Name	Time	Method
Estimated time to achieve sensory block upto T10, maximum level of sensory block, time taken for 2 segment regression from maximum level of sensory block, time required for onset of motor block , time required for complete recovery of motor block, total duration of sensory block from time of injection to first demand for analgesia	3 hours

Trial Locations

Locations (1)

3rd floor OT emergency building and ward of ESIC PGIMSR ESIC Medical College Joka; 🇮🇳 Kolkata, WEST BENGAL, India

3rd floor OT emergency building and ward of ESIC PGIMSR ESIC Medical College Joka

🇮🇳Kolkata, WEST BENGAL, India

Dr Saswati Nag Porel

Principal investigator

7003938439

porelsaswati@gmail.com