A study to compare the effect of low dose versus conventional dose intrathecal fentanyl with hyperbaric bupivacaine on the block characteristics in parturient undergoing caesarean section under spinal anaesthesia

Not yet recruiting

• Conditions: Encounter for cesarean delivery without indication,

• Registration Number: CTRI/2021/08/035932
• Lead Sponsor: Lairikyengbam Sheityajit Roy

Brief Summary

The study is a prospective randomizeddouble-blinded trial to assess and compare the effects of intrathecaladministration of low dose 12.5µgm and conventional25µgm fentanyl citrate with 0.5% bupivacaine (2 ml, heavy) in parturientundergoing LSCS procedures under subarachnoid block which will be conducted in the Department of Anaesthesiology, regional Institute of Medical Sciences, Imphal, Manipur. Atotal of 60 parturient will be selected for the study and divided into 2 groupsof 30 patients each viz. Group A (n-30) and Group B (n-30) .According to a computer generated randomizationtable, patients in group A will be administered 2 ml of 0.5% bupivacaine heavyplus 0.5ml (12.5µgm) fentanyl citrateand group B willbe administered 2 ml of 0.5% bupivacaine heavy plus 0.5ml (25 µgm)  fentanyl citrate in the subarachnoid spaceL3-L4 In both the groups,the study drugs will be administered at a rate of 0.2 ml/min. in thesubarachnoid space L3-L4.  The time to first rescue analgesia, blockcharacteristics along with regression of the blockade, side effects (if any)and the hemodynamic changes will be observed, assessed and recorded by blindedinvestigator using the VAS, sedation scale, modified Bromage scale.The data collected will be collected and analysedusing Student‘t’ test  for continuousdata  and Chi-square test  for categorical data as and where appropriate.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-08-24
• Study Start: 2021-08-26

Recruitment & Eligibility

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

Inclusion Criteria

(ASA) physical status I or II undergoing lower segment caesarean section under spinal anaesthesia.

Exclusion Criteria

1.History of allergy to study drugs 2.Bleeding disorder-platelet count <50,000/micro litre, prothrombin time>14sec,International normalised ratio(INR)->1.5 3.Local site infection 4.Cardiac, respiratory diseases and kidney disorder, neurological deficit 5.Spinal deformity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of analgesia [Time (minutes) to demand of first rescue analgesic assessed by visual analogue scale]	From time of intrathecal injection (baseline) to the time when patient first demands rescue analgesia (minutes)

Secondary Outcome Measures

Name	Time	Method
1.Hemodynamic profile- pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), Oxygen saturation (SpO2)	2.Time of sensory block at onset T 10(secs)

Trial Locations

Locations (1)

Regional Institute of Medical Sciences, Imphal; 🇮🇳 West, MANIPUR, India

Regional Institute of Medical Sciences, Imphal

🇮🇳West, MANIPUR, India

Lairikyengbam Sheityajit Roy

Principal investigator

7005155846

thoithoi2402@gmail.com