Comparision of 2 drugs( hyperbaric bupivacaine and hyperbaric ropivacaine) used in spinal anaesthesia for caeserean section in patients with pregnancy induced hypertension


Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/11/060021
• Lead Sponsor: RAJESHKUMAR N

Brief Summary

Spinal anaesthesia or sub-arachnoid block (SAB), is commonly employed for caesarean sections. It is associated with various complications like hypotension and delayed ambulation. Presently Inj.0.5% hyperbaric bupivacaine is the most widely used drug for spinal anaesthesia. Though Inj. Hyperbaric Bupivacaine is widely used and very effective in Spinal Anaesthesia, it has the propensity to cause adverse hemodynamic effects. It is more lipophilic causing both sensory and motor blockade for prolonged duration. In today’s world, where minimal side effects and early ambulation are the demands of the hour, studies done with 0.5% ropivacaine made hyperbaric by addition of 25% dextrose have found it to be an alternative for Inj. Hyperbaric bupivacaine causing less cardiac side effects and providing early ambulation due to its sensorimotor dissociation and early regression.

Literature search shows studies have so far been done with prepared hyperbaric ropivacaine by anaesthesiologist under aseptic conditions. Commercially available Inj. 0.75% Hyperbaric Ropivacaine has been recently introduced in India and it has not been studied in PIH parturients.

Commercially available Inj. 0.75% Hyperbaric Ropivacaine provides reliable Spinal Anaesthesia as Inj. Hyperbaric Bupivacaine. Based on the results of the study, Inj. 0.75% Hyperbaric Ropivacaine can be a safer alternative to Inj.0.5% hyperbaric Bupivacaine in providing better hemodynamic profile and early ambulation.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-11-17
• Study Start: 2023-11-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

Hypertensive disorders of pregnancy planned for elective caesarean section under Spinal Anaesthesia.

Exclusion Criteria

Hypersensitivity to any of the study drugs, Patients with spinal deformity, Patients with coagulopathy, Short stature (less than 140 cms), Elderly primigravida, Precious pregnancy, Other comorbidities like Diabetes Mellitus, CAD, Congenital heart diseases, Valvular heart diseases etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the incidence of hypotension with Inj. 0.75% Hyperbaric Ropivacaine as compared to Inj. 0.5% Hyperbaric Bupivacaine during Spinal Anaesthesia for Caesarean Section in PIH	Untill patient is shifted to recovery room

Secondary Outcome Measures

Name	Time	Method
1)To compare the onset and regression of sensory block up to T10 between 2 groups.	2)To compare the onset and regression of motor block between 2 groups.

Trial Locations

Locations (1)

Jawaharlal Institute of Postgraduate Medical Education and Research; 🇮🇳 Pondicherry, PONDICHERRY, India

Jawaharlal Institute of Postgraduate Medical Education and Research

🇮🇳Pondicherry, PONDICHERRY, India

Dr RAJESHKUMAR N

Principal investigator

9488997201

drnrajeshkumar@gmail.com