To test the effectiveness of two drugs for spinal anaesthesia in below umbilical surgeries.

Not yet recruiting

• Conditions: Open wound of other parts of abdomen, lower back and pelvis,

• Registration Number: CTRI/2023/07/055159
• Lead Sponsor: Not Applicable

Brief Summary

Subarachnoid block has been a popular anesthesia techniquefor infra-umbilical and lower limb surgeries. Hyperbaric racemic bupivacaine iscommonly used for subarachnoid due to its long duration of action and combinedmotor and sensory blockade. However, the use of hyperbaric racemic bupivacainein subarachnoid block has some drawbacks. It has a high propensity to causehypotension and bradycardia following intrathecal injection, and there ispotential for catastrophic cardiac toxicity due to the high affinity ofbupivacaine to cardiac myocytes. Levobupivacaine, an amide local anestheticwhich is the isolated S-enantiomer of bupivacaine.

Racemic bupivacaine is an equimolar mixture of dextro andlevobupivacaine. Levobupivacaine has a lower affinity for cardiac sodiumchannels and greater plasma protein binding affinity compared with the dextroisomer; thus, reducing the risk of cardio-toxicity.

Levobupivacaine also results in earlier motor recovery compared withracemic bupivacaine. These advantages make levobupivacaine an attractivealternative to racemic bupivacaine for sub arachnoid block. However itsclinical efficacy in subarachnoid block should be known first.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-30
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Age group 18-60 years of either age.
• 2. Patients with ASA grade I and II 3) patients with average height (>5 feet).
• 4. All patients undergoing infra-umbilical surgeries.

Exclusion Criteria

• 1. Patient refusal or not giving consent.
• 2. Patients with the Neurological disease, bleeding diathesis, Coagulopathy disorders.
• 3. Patients with spine/Neurological deformities, 4) Local Skin infections or disease.
• 5. History of drug allergy.
• 6. Patients on tranquilizers, hypnotics, sedatives and other psychotropic drugs.
• 7. Severe liver or kidney diseases.
• 8. ASA grade III and IV, V.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of Hyperbaric Levobupivacaine (0.5%) & Hyperbaric Bupivacaine (0.5%) on the onset & duration of sensory and motor block and to evaluate perioperative hemodynamic effects	Immediately after induction till 180 minutes.

Secondary Outcome Measures

Name	Time	Method
To evaluate the post-operative analgesia.	To evaluate the occurrence of side effects & complications, if any.

Trial Locations

Locations (1)

Gandhi medical College Bhopal; 🇮🇳 Bhopal, MADHYA PRADESH, India

Gandhi medical College Bhopal

🇮🇳Bhopal, MADHYA PRADESH, India

Dr Pranita Jain

Principal investigator

9146196376

pranitajain0508@gmail.com