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TO COMPARE FRACTIONATED WITH SINGLE DOSE OF SPINAL ANAESTHESIA IN PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES

Not yet recruiting
Conditions
Diseases of the musculoskeletal system and connective tissue,
Registration Number
CTRI/2025/06/088821
Lead Sponsor
Sakshi Dhingra
Brief Summary

This study is a comparative randomised double blind study of fractionated with bolus dose of 0.5% hyperbaric bupivacaine with 25 mcgs Fentanyl in spinal anaesthesia for patients undergoing lower limb orthopaedic surgeries. The objective of the study is to compare the haemodynamic changes at different time intervals , onset and duration of sensory and motor block , duration of analgesia till the first request for rescue analgesics and side effects seen among the two groups . Total 60 patients will be randomly selected which belongs to ASA I-III . 60 patients will be divided into two groups 30 in each group by using sealed envelope technique . One group will recieve drug as bolus and other will recieve drug in fractionated manner. The drug will be given to all patients using 25 G Quincke’s spinal needle in sitting position.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria
  1. Physical status I-III according to American Society of Anesthesiologists 2) Willing for spinal anaesthesia 3) Patients undergoing lower limb orthopaedic surgeries 4) BMI less than 35.
Exclusion Criteria
    1. Absolute contraindications of spinal anaesthesia such as localized infection at injection site, patient’s inability to position during the procedure , patient’s refusal, allergy to anaesthetic drugs, increased intracranial pressure 2) Relative contraindication to spinal anaesthesia such as myelopathy or peripheral neuropathy, spinal stenosis, history of spinal surgery, spinal deformities, multiple sclerosis, spina bifida, aortic stenosis , altered mental status & coagulopathies.
    1. BMI equal to or more than 35 4) Ineffective block with conversion to general anaesthesia.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Haemodynamic changes [Mean Arterial Pressure (MAP), Non Invasive Blood PressureThe heart rate and blood pressure will be monitored at base line, just before subarachnoid block then at 5,10,15,20,40,60,80,100,120 mins and thereafter every | 20 mins till the duration of surgery after giving spinal anaesthesia.
(NIBP) & Heart Rate (HR)] at different time intervals.The heart rate and blood pressure will be monitored at base line, just before subarachnoid block then at 5,10,15,20,40,60,80,100,120 mins and thereafter every | 20 mins till the duration of surgery after giving spinal anaesthesia.
Secondary Outcome Measures
NameTimeMethod
1)Onset and duration of sensory and motor block using pinprick test and modified Bromage scale2)Duration of analgesia till the first request for rescue analgesic using VAS pain score

Trial Locations

Locations (1)

SGT HOSPITAL

🇮🇳

Gurgaon, HARYANA, India

SGT HOSPITAL
🇮🇳Gurgaon, HARYANA, India
Dr Sakshi Dhingra
Principal investigator
9711355379
dhingrasakshi2@gmail.com

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