Spinal Anaesthesia for lower abdominal and lower limb surgeries- Comparison of Heavy formulations of Levobupivacaine, ropivacaine with racemic bupivacaine

Not yet recruiting

• Registration Number: CTRI/2023/02/049556
• Lead Sponsor: Dr Juliet Ann Abraham

Brief Summary

Spinal Anaesthesia is the gold standard for infraumbilical surgeries. Commonly used as spinal anaesthetic is 0.5% Hyperbaric Bupivacaine in spite of their cardiotoxic and neurotoxic property, if intravascular access is gained. This is due to the R- enantiomer component which has increased affinity for the sodium channels in cardiac tissue. This led to the formulation of levobupivacaine and ropivacaine, pure S-enantiomers and long acting local anaesthetic agents. Until recently Hyperbaric solutions of levobupivacaine and ropivacaine were not available. Hence this study. It is a proposed randomised control trial, where the patients are counselled regarding the procedure and their consent is attained. They are divided into groups of three with 35 in each given and given their allocated drug. The different parameters studied are the onset and duration of motor and sensory blockade, post-operative analgesia, hemodynamic parameters and complications. The results are then tallied to compare the efficiency and safety profile of levobupivacaine and ropivacaine against racemic bupivacaine.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-02
• Study Start: 2023-10-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

ASA I-11 Age 20- 70 years Height 150-180cms Infraumbilical surgeries >2 hours.

Exclusion Criteria

Patient refusal Local infection Coagulopathies Allergy to the study drugs Any pre-existing neurological deficits Parturients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of onset and duration of motor blockade	The onset of the maximum motor blockade- attaining Grade 4 on the Modified Bromage scale- checked every 3 mins from the time of administration (3 mins, 6 mins, 9 mins, 12 mins) | The duration of the motor blockade- from the onset of the motor blockade [(Grade 4 on Modified Bromage scale), peaking at (Modified Bromage scale Grade 1)]till the effect of the drug is completely subsided (Modified Bromage scale Grade 6) - checked every 20 mins post-surgery (20 mins, 40 mins, 60 mins..120mins )

Secondary Outcome Measures

Name	Time	Method
1. To compare the onset and duration of sensory blockade	The onset of the sensory blockade - blockade at the level of T10 dermatome - checked every minute from the time of administration of the drug (1 min, 2 min, 3 min, 4 min, 5 min)
To compare the total consumption of rescue analgesia when the comparator agent and interventional agents are administered	The total consumption of rescue analgesia is determined by the need for intravenous analgesics for the first 6 hours post-surgery (1st hour, 2nd hr...6th hour)
Comparison of intraoperative hemodynamic profile and occurrence of adverse effects with each study drug	Vitals are recorded every two minutes from the time of administration of the drug (0 min, 2 mins, 4 mins...) for the first 20 minutes and then every 5 minutes till the end of the surgical procedure.

Trial Locations

Locations (1)

MOSC Medical College Hospital; 🇮🇳 Ernakulam, KERALA, India

MOSC Medical College Hospital

🇮🇳Ernakulam, KERALA, India

Dr Juliet Ann Abraham

Principal investigator

9188605017

juliet_ann19@ymail.com