LEVOBUPIVACAINE AND BUPIVACAINE -A COMPARISON

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/01/049345
• Lead Sponsor: PALLAVI SAXENA

Brief Summary

Spinal anesthesia has been a popular anesthesia technique for short urological surgeries.. Hy­perbaric racemic bupivacaine is commonly used for spinal an­esthesia due to its long duration of action and combined motor and sensory blockade. However, the use of hyperbaric racemic bupivacaine in spinal anesthesia has some drawbacks. It has a high propensity to cause hypotension and bradycardia follow­ing intrathecal injection, and there is potential for catastrophic cardiac toxicity due to the high affinity of bupivacaine to cardiac myocytes. Racemic bupivacaine is an equimolar mixture of dextro and levobupivacaine. Levobupivacaine has a lower affinity for car­diac sodium channels and greater plasma protein binding affin­ity compared with the dextro isomer; thus, reducing the risk of cardio-toxicity [3–5].  Levobupivacaine also results in earlier motor recovery compared with racemic bupivacaine [8,9]. These advantages make levobupivacaine an attractive alternative to racemic bupivacaine for spinal anesthesia.

Urological surgeries are performed under regional anaesthesia with subarachnoid blockade on a wide variety of patients ranging from the young, physically fit to the elderly with multiple comorbidities.Most of the patients presenting for urological surgeries belong to the geriatric population having a coexisting cardiac,pulmonary condition,or some other comorbidities.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-02
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

•Age 60 to 90yrs •height 145–180 cm •weight 50–100 kg •Both genders- male and female •ASA grade I and ASA grade II •Undergoing elective urological surgery of maximum 2 hrs of duration under spinal anaesthesia.

Exclusion Criteria

• 1.Age <60 yrs, > 90 yrs 2.Height<145cm, > 180 cm 3.Weight <50kgs, > 100 kg 4.ASA grade III and ASA grade IV 5.Patients with hepatic, cardiac, pulmonary, neuropsychiatric, renal or thyroid disease 6.Hypersensitivity to Bupivacaine or levobupivacaine.
• 7.Any contraindication to spinal anaesthesia ( local infection, spinal deformity, coagulopathy).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study will help us to determine whether there is any significant difference between the hemodynamic parameters changes in elderly patients (age 60 to 90 yrs) undergoing urological surgeries between levobupivacaine (0.5%hyperbaric)and bupivacaine(0.5%hyperbaric) and compare the onset and duration of sensory action and motor action between them.	3MINS | 5MINS | 10MINS | 15MINS | 30MINS | 45MINS | 60MINS | 90MINS | 120MINS

Secondary Outcome Measures

Name	Time	Method
hemodynamic parameters (Pulse rate & Blood pressure). 2. quality of anesthesia (onset and duration of sensory and motor blockade),	3.adverse effects of levobupivacaine (0.5%hyperbaric) and bupivacaine (0.5%hyperbaric). 4.post operative cognitive status.

Trial Locations

Locations (1)

BJ GOVERNMENT MEDICAL COLLEGE AND SASSOON GENERAL HOSPITAL PUNE; 🇮🇳 Pune, MAHARASHTRA, India

BJ GOVERNMENT MEDICAL COLLEGE AND SASSOON GENERAL HOSPITAL PUNE

🇮🇳Pune, MAHARASHTRA, India

DR PALLAVI SAXENA

Principal investigator

9893445456

itgetsboring@gmail.com