Comparing two local anaesthestic drugs in C-section under spinal anaesthesia

Not yet recruiting

• Conditions: Obstetrics, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2023/02/049800
• Lead Sponsor: Tagore Medical college and Hospital

Brief Summary

prospective, Randomised control study to compare the efficacy of hyperbaric Ropivacaine over the hyperbaric Bupivacaine (control drug) in lower uterine segment caesarean section under spinal anaesthesia, the motor and sensory blockade and its regression is the primary outcome and to evaluate the hemodynamic changes that are caused due to the hyperbaric Ropivacaine and its alterations with spinal anaesthesia is the secondary outcome

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-20
• Last Update Posted: 2023-02-25

Recruitment & Eligibility

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

Inclusion Criteria

Caesarean section under ASA II.

Exclusion Criteria

• Patients refusal to participate in the study.
• Patient who are medical unstable i.e. Patients who come under ASA Grade 3 and above.
• Known hypersensitivity to any drugs that are to be studied.
• Failed spinal anaesthesia and general anaesthesia required for previous surgery Presence of Spinal Anaesthesia contra-indications.
• Patients on anticoagulants or anti-platelets therapy or patients with Bleeding diathesis or Coagulopathy.
• Patients with spine deformity and puncture site infection.
• Neurological or Neuromuscular disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare and evaluate the clinical efficacy i.e. the motor and sensory blockade of equal doses of hyperbaric 0.75% Ropivacaine with hyperbaric 0.5% Bupivacaine in LSCS under spinal anaesthesia	Post spinal, every 3 minutes for first 15 minutes, every 5 minutes till end of surgery

Secondary Outcome Measures

Name	Time	Method
The hemodynamic changes Pulse rate(PR), systolic blood pressure ( SBP), diastolic blood pressure (DBP) that are caused due to the hyperbaric Ropivacaine in lower segment caesarean section under spinal anaesthesia	Baseline,Pre-spinal,Post spinal every 2 minutes for first 10 minutes, 5 minutes till end of procedure

Trial Locations

Locations (1)

Tagore Medical college and Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Tagore Medical college and Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Janaki Rethna Sharon

Principal investigator

7904152162

janakirethnasharon@gmail.com