Comparison of Intrathecal Injection of same dose of Fentanyl at Different Rates in Patients undergoing Elective LSCS

A prospective randomized controlled double blinded interventional study to compare postoperative analgesia using sequential intrathecal injection of fentanyl at different rates with hyperbaric bupivacaine in lower segment caesarean sections at SMS Medical College, Jaipur during 2021-2023

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042039

Enrollment

Registered

2022-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: inj fentanyl: Rapid intrathecal injection(1-2sec) of Fentanyl 0.5ml with an insulin syringefollowed by slow injection of 2ml of hyperbaric bupivacaine with a 5ml syringe Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing Elective LSCS under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1)ASA Grade 3&4,2)Parturients with complicated pregnancies such as those with pre-eclampsia,pregnancy induced hypertension,gestational diabetes,abnormal placenta(placenta previa),multiple gestation,BMI >35 or 3)Parturients with a need for emergency CS. 4)Parturientswho are allergic to drugs used in this study 5)Parturients contraindicated for spinal anaesthesia 6)Parturients who refused spinal anaesthesia.

Design outcomes

Primary

Measure	Time frame
Total duration of post operative analgesiaTimepoint: until 6hrs postoperatively	—

Secondary

Measure	Time frame
Dose of rescue analgesia usedTimepoint: postoperatively every 30 min until 6hrs;duration of motor blockTimepoint: time taken to return to a bromage score of 0;Haemodynamic Parameters (systolic BP,Diastolic BP, Mean arterial pressure, Heart Rate,spo2)Timepoint: baseline,2min,4min,6min,8min ,10 min,15min, 20 min and then every 10 min till 60 min;Intensity of Post operative Pain assesesd by VAS ScoreTimepoint: postoperatively every 30 min until 6 hrs;Intra operative HypotensionTimepoint: intraoperatively;onset of motor blockTimepoint: time taken to achieve a Bromage score of 3;onset of sensory block and highest level of sensory blockTimepoint: after 10 min;Spinal anaesthesia related complicationsTimepoint: intraoperatively	—

Measure

Time frame

Dose of rescue analgesia usedTimepoint: postoperatively every 30 min until 6hrs;duration of motor blockTimepoint: time taken to return to a bromage score of 0;Haemodynamic Parameters (systolic BP,Diastolic BP, Mean arterial pressure, Heart Rate,spo2)Timepoint: baseline,2min,4min,6min,8min ,10 min,15min, 20 min and then every 10 min till 60 min;Intensity of Post operative Pain assesesd by VAS ScoreTimepoint: postoperatively every 30 min until 6 hrs;Intra operative HypotensionTimepoint: intraoperatively;onset of motor blockTimepoint: time taken to achieve a Bromage score of 3;onset of sensory block and highest level of sensory blockTimepoint: after 10 min;Spinal anaesthesia related complicationsTimepoint: intraoperatively

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Countries

India

Contacts

Public ContactDr Nelwin Jerald Sabu

Sawai Man Singh Medical College and Attached Hospitals

rupihar@gmail.com9899785993

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026