Comparing the effects between two different medicine to reduce pain by giving an injection through the backbone while delivering baby by a cut made in mother’s abdomen

A comparative study between low dose intrathecal morphine and fentanyl combined with (0.5 percent) hyperbaric bupivacaine for postoperative analgesia in elective caesarean section - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072938

Enrollment

Registered

2024-08-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Inj. Bupivacaine Hydrochloride (0.5 percent) (hyperbaric), Inj. Morphine Sulphate (15mg/ml) (preservative free), 0.9% Sodium Chloride: Intrathecally 10mg [2.0ml] Inj. Bupivacaine Hydroc

Eligibility

Inclusion criteria

Inclusion criteria: Term (more than 37 weeks) pregnant women, Pregnant women (ASA grade II including women with mild PIH and controlled gestational diabetes) posted for elective caesarean section under spinal anaesthesia, Patients willing for elective caesarean section, Those who can give valid informed written consent for participation.

Exclusion criteria

Exclusion criteria: Patients not willing to give consent, Known allergy to amide local anaesthetics, fentanyl citrate and morphine sulphate, Patients with contraindications to subarachnoid block, patients with cardiovascular disease, severe preeclampsia, uncontrolled gestational diabetes, preexisting neurological disease, Deformities of spinal column in severe degree, Emergency LSCS, ASA grade III and above, Failed spinal anaesthesia, Antepartum haemorrhage, Morbid obese (BMI more than equals to 40), Incomplete medical record data.

Design outcomes

Primary

Measure	Time frame
Duration of postoperative analgesia.Timepoint: From the time of end of surgery till the first demand of rescue analgesic.	—

Secondary

Measure	Time frame
Heart RateTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours. ;Systolic Blood PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Diastolic Blood PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Mean Arterial PresureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Oxygen Saturation (SPO2)Timepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Respiratory RateTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;APGAR Score (Neonatal status)Timepoint: At 1 min,then 5 min after delivery;Visual Analogue Score (Level of pain)Timepoint: Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then 6 hourly thereafter till 24 hours.;Ramsay Sedation Score (Level of sedation)Timepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Pinprick method (Level of sensory block)Timepoint: Intraoperatively every 5 min for first 30mi	—

Measure

Time frame

Heart RateTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours. ;Systolic Blood PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Diastolic Blood PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Mean Arterial PresureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Oxygen Saturation (SPO2)Timepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Respiratory RateTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;APGAR Score (Neonatal status)Timepoint: At 1 min,then 5 min after delivery;Visual Analogue Score (Level of pain)Timepoint: Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then 6 hourly thereafter till 24 hours.;Ramsay Sedation Score (Level of sedation)Timepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Pinprick method (Level of sensory block)Timepoint: Intraoperatively every 5 min for first 30mi

—

Countries

India

Contacts

Public ContactDr Arup Dasgupta

ICARE ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital

arupdg55@gmail.com9831009434

Outcome results

None listed

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