a clinical trial to compare efficacy of the analgesic activity of inj. Bupivacaine vs inj. Ropivacaine given at transverse abdominis block and also compare the safety parameters also.

Phase 4

Not yet recruiting

• Conditions: lower segment cesarean section indication

• Registration Number: CTRI/2017/08/009249
• Lead Sponsor: Department of Anaesthesiology

Brief Summary

Thisstudy is prospective, randomized, controlled, double blind study parallelgroup, comparing the safety and efficacy of bupivacaine and ropivacaine in transversusabdominis plane block after lower segment cesarean section.

Inthis study bupivaiane will be given in transversus abdominis plane block afterlower segment cesarean section in dose of 0.25% 15 ml bilataerally an in othergroup ropivacainewill be given in dose of 0.25% 15 ml bilataerally

Theprimary outcome is- To compare efficacy and safety of bupivacaine  and ropivacaine   for post operative pain relief in lowersegment cesarean section with Visual Analogue Score and total dose of rescueanalgesia.

 The secondary outcomes are- Effect on hemodynamic variables like Heart Rate(HR), Mean Arterial Pressure (MAP), Oxygen saturation (SpO2).

Sideeffects & Complications if any.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-02-08
• Study Start: 2017-09-20

Recruitment & Eligibility

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

Inclusion Criteria

• Informed written consent for participation in study.
• Age: 20-35 years Gender: Antenatal female patients scheduled for elective or non urgent lower segment cesarean section.
• ASA physical status I and II.
• Patients refusing consent.

Exclusion Criteria

• 1.Contraindications to Spinal Anaesthesia like, Local infection or sepsis at the site of Lumbar puncture Bleeding disorders, thrombocytopenia Space occupying lesions of the brain Anatomical disorders of the spine Hypovolaemia e.g. following massive haemorrhage 2.Allergy to local anaesthetic drugs and NSAIDS.
• 3.Patient on any form of analgesics therapy.
• 4.BMI ≥ 25 kg/m2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare efficacy and safety of bupivacaine and ropivacaine for post operative pain relief in lower segment cesarean section with Visual Analogue Score and total dose of rescue analgesia.	1st day of lower cesarean section(First 24 hours after lower segment cesarean section)

Secondary Outcome Measures

Name	Time	Method
Effect on hemodynamic variables like Heart Rate (HR), Mean Arterial Pressure (MAP), Oxygen saturation (SpO2).	Side effects & Complications if any.

Trial Locations

Locations (1)

Sit Takhtsinhji General Hospital; 🇮🇳 Bhavnagar, GUJARAT, India

Sit Takhtsinhji General Hospital

🇮🇳Bhavnagar, GUJARAT, India

Dr Ravikumar Parmar

Principal investigator

9099097807

ravirajparmar1@gmail.com