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A study to compare the characteristics of two durgs (hyperbaric (0.5%) Bupivacaine and hyperbaric (0.75%) Ropivacaine ) which is used for loss of pain sensation over lower half of body by giving injection in lower vertebral canal in Cesarean Section.

Not yet recruiting
Conditions
Pregnancy, childbirth and the puerperium,
Registration Number
CTRI/2022/05/042898
Lead Sponsor
DR PRATIBHA JAIN SHAH
Brief Summary

In this study we give one of the our study drug to pregnant  patients for lscs in spinal anaesthesia.We use double blindtechnique .in which patient and investigator will be blind to study drug whichwill be given to patient .The drug will be prepared by an anaesthesiologistother than the principal investigator, who will be blinded to the studyprotocol and will not be involved in further data collection and assessment ofpatient . All patients will be informed and explained about the procedure .themultipara monitor will be attached to patients in supine position and baselinevital parameters such as BP, HR , RR and SpO2 will be recorded. An intravenousline will be established with 18 g cannula to preload the patient with ringerlactate solution at 10 ml /kg before the initiation of spinal block. Thenpremedication will be done with inj ondansetron 4mg iv .spinal anaesthesia willbe given at sitting position at the L3-L4 level identified by land marktechnique . with a 25-g Quincke’s spinal needle .our primary outcome is onsetof sensory block at the t10 level and secondary outcome are onset  ofmotor block, duration  of sensory & motor block.grade of sensory &motor block,duration of analgesia ,hemodynamic changes( BP ,HR ,RR, SpO2). sideeffects and complications(nausea, vomiting, hypotension, shivering ,respiratorydistress ) .

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
80
Inclusion Criteria
  • 1 ASA grade 2 Age between 18 to 40 yrs .
  • 3 BMI <30 KG/M2 4 Height 150-170 cm.
  • 5 Elective cesarean section under spinal anaesthesia.
Exclusion Criteria
  • 2 Any neurological condition like demylinating lesions,increased intracranial tension, and head injuries .
  • 3 Diabetes mellitus,hypertension,renal,hepatic ,pulmonary or pre-existing cardiac diseases(severe mitral stenosis or severe aortic stenosis).
  • 4 Contraindication to spinal anaesthesia.
  • 5 Chronic pain medication.
  • 6 bleeding or coagulation disorders and those on anticoagulant therapy.
  • 7 History to allergy of study drug.
  • 8 Partial or failed Spinal anaesthesia .

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1 Onset of sensory block at the T10 levelWITHIN 30 MIN after spinal anaesthesia for LSCS.
Secondary Outcome Measures
NameTimeMethod
1 Onset of motor block.2 Duration of sensory & motor block.

Trial Locations

Locations (1)

Dr Bhim Rao Ambedkar Memorial Hospital ,Raipur

🇮🇳

Raipur, CHHATTISGARH, India

Dr Bhim Rao Ambedkar Memorial Hospital ,Raipur
🇮🇳Raipur, CHHATTISGARH, India
Dr Mohammed Firoz Sheikh
Principal investigator
8319824046
firozsheikh78@gmail.com

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