A comparative study between spinal drug ropivacaine versus bupivacaine in planed surgery under spinal anaesthesia

Not yet recruiting

• Conditions: Measurement and Monitoring,

• Registration Number: CTRI/2022/08/044660
• Lead Sponsor: GCS Medical College hospital and researah centre

Brief Summary

A Comparative Evaluation of IntrathecalHyperbaricRopivacaineversus HyperbaricBupivacaine in Elective Surgery UnderSpinalAnaesthesia

Aims and Objective :

Tocompare the anaesthetic and analgesic efficacy of  Intrathecal Hyperbaric  Ropivacaine and Hyperbaric Bupivacaine in patients posted for surgeries underspinal anaesthesia. Primary objective is toevaluate the efficacyand safety of hyperbaricRopivacaine forNeuraxial  blockade compared to hyperbaric Bupivacaine and the secondary objective is tocompare the relative advantages and disadvantages of both the drugs, onset andduration of anaesthesia, perioperative hemodynamic and any adverse effects.

 Material and methods:

•ProspectiveRandomizedControlledStudy

•Total= 200 patients. ASAgrade I and II arerandomlyselected for the study and  dividedinto two groups of 100each.

•Twogroups Group B - receive3.5 ml of0.5% hyperbaric bupivacaine intrathecally.

•GroupR  - receive 3.5 ml of 0.75% hyperbaric ropivacaine intrathecally.

•Onsetand extent of sensory block, onset and duration of motor block, the maximum heightof sensory block, and duration of analgesia, hemodynamic parameters and adverseeffects if any are studied.

**conclusion:**

Ropivacainehas less cardio toxicity and neurotoxicity than Bupivacaine

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-04-08
• Study Start: 2022-05-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patient with informed consent Age between 18 to 75 Years BMI<30kg/m2 ASA I & II Infra umbilical Surgery <3 hours.

Exclusion Criteria

Patient who will not give consent BMI>30kg/m2 ASA III & IV Contraindication to spinal anaesthesia Known Allergy to Ropivacaine or any other local Anaesthetic Agent Duration of Surgery > 3hours Patients on chronic Anticoagulation or Antiplatelet drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess between Ropivacaine and Bupivacaine which has less cardiac and neurological complication	immediate after giving spinal anaesthesia

Secondary Outcome Measures

Name	Time	Method
To assess the Hemodynamics parameters and the regression of motor and sensory effects between ropivacaine and bupivacaine	After 4 hours of giving spinal anaesthesia

Trial Locations

Locations (1)

GCS Medical College hospital and research centre; 🇮🇳 Ahmadabad, GUJARAT, India

GCS Medical College hospital and research centre

🇮🇳Ahmadabad, GUJARAT, India

Dr Ankita Patel

Principal investigator

9712981484

drankitapatel30@gmail.com