Skip to content

A study to compare the pain reduction effect between two drugs via an injection through the backbone while delivering baby by a cut in the lower abdomen of the mother.

Comparison of hemodynamic disturbances and postoperative analgesia between intrathecal bupivacaine with buprenorphine as adjuvant and intrathecal bupivacaine alone in lower segmental caesarean section: A randomised controlled study - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081915
Enrollment
82
Registered
2025-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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. Buprenorphine Hydrochloride (0.3mg/ml) (preservative free): Intrathecally 10mg [2.0ml] Inj. Bupivacaine Hydrochloride (0

Sponsors

Dr Koushik Baran Roy
Lead Sponsor

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 and buprenorphine, 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, Less than 18 years or more than 35 years of age, ASA grade III and above, Failed spinal anaesthesia, Antepartum haemorrhage, Morbid obese (BMI more than equals to 40)

Design outcomes

Primary

MeasureTime frame
Duration of postoperative analgesiaTimepoint: From the time of end of surgery till the first demand of rescue analgesic.

Secondary

MeasureTime frame
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 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 (till 2 segment regression from maximum level);Modified Bromage Score (Level of motor block)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;PruritusTimepoint: From the time of intrathecal injection till 24 hours after surgery.;NauseaTimepoint: From the time of intrathecal injection till 24 hours after surgery.;VomitingTimepoint: From the time of intrathecal injection till 24 hours after surgery.;Total amount of vasopressor requiredTimepoint: From the time of intrathecal injection till 24 hours after surgery.;Total no. of topup rescue analgesic requiredTimepoint: From the time of intrathecal injection till 24 hours after surgery.;ShiveringTimepoint: From the time of intrathecal injection till 24 hours after surgery.;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 ever

Countries

India

Contacts

Public ContactDr Arup Dasgupta

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: Sep 19, 2026