comparsion of bupivacine heavy with fentanyl and ropivacine heavy with fentanyl for spinal anaesthesia

Not yet recruiting

• Conditions: ASA 1 & 2 patients undergoing orthopedic lower limb surgeries

• Registration Number: CTRI/2023/04/051449
• Lead Sponsor: Dr Meenakshi Telang

Brief Summary

A randomised prospective study for clinicalcomparison of intrathethecal Hyperbaric Bupivacaine with Fentanyl versusintrathecal Hyperbaric Ropivacaine with fentanyl for patients undergoingorthopedic lower limb surgeries.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-30
• Study Start: 2023-10-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

ASA GRADE 1 & 2, WEIGHING 55-85 KG SCHEDULED FOR ELECTIVE ORTHOPEDIC LOWER LIMB SURGERY.

Exclusion Criteria

• 1.Uncooperative patient.
• 2.Refusal to technique or enrolment for study.
• 3.Known hypersensitivity to study drugs or using any drug that modifies pain perception.
• 4.Deformity/Abnormality of spinal column.
• 5.Infection at site of lumbar puncture.
• 6.Patients with physical status of ASA grade III or greater.
• 7.Patients with history of severe cardiac or pulmonary disease, poorly controlled hypertension.
• 8.Morbidly obese patients, neurologic or psychological disease, hepatic or renal dysfuction, endocrinal or metabolic disorders.
• 9.Bleeding or coagulation disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To evaluate and compare the onset and duration of sensory and motor blockade after intrathecal bupivacaine heavy with fentanyl and intrathecal ropivacaine heavy with fentanyl.	immediate postop, | 1st 30 mins postop, | 1 hour postop, | 2 hours postop, | 3 hours postop, | 4 hours postop, | 5 hours postop, | 6 hours postop
4.To evaluate and compare the hemodynamic changes of systemic BP and HR.	immediate postop, | 1st 30 mins postop, | 1 hour postop, | 2 hours postop, | 3 hours postop, | 4 hours postop, | 5 hours postop, | 6 hours postop
2.To evaluate and compare the time taken for two dermatome sensory regression to S1 after intrathecal administration of bupivacaine with fentanyl and ropivacaine with fentanyl.	immediate postop, | 1st 30 mins postop, | 1 hour postop, | 2 hours postop, | 3 hours postop, | 4 hours postop, | 5 hours postop, | 6 hours postop
3.To compare the post op analgesia.	immediate postop, | 1st 30 mins postop, | 1 hour postop, | 2 hours postop, | 3 hours postop, | 4 hours postop, | 5 hours postop, | 6 hours postop

Secondary Outcome Measures

Name	Time	Method
1.To determine any side effects due to Bupivacaine, Ropivacaine or Fentanyl during the study period.	1 hour post operatively

Trial Locations

Locations (1)

CHHATRAPATI SHIVAJI SUBHARTI HOSPITAL; 🇮🇳 Meerut, UTTAR PRADESH, India

CHHATRAPATI SHIVAJI SUBHARTI HOSPITAL

🇮🇳Meerut, UTTAR PRADESH, India

Dr Meenakshi Telang

Principal investigator

9977769160

telang.meenakshi@gmail.com