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A Study comparing the hemodynamic and spinal block characteristics of isobaric ropivacaine with hyperbaric bupivacaine for caesarean delivery in patients with pregnancy induced hypertension

A randomized controlled trial to compare intrathecal isobaric ropivacaine with hyperbaric bupivacaine for caesarean delivery in patients of pregnancy induced hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018310
Enrollment
104
Registered
2019-03-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O16- Unspecified maternal hypertension

Interventions

Intervention1: Group BM & Group RM: Group BM- 2ml of 0.5% hyperbaric bupivacaine + 0.15mg preservative free morphine (0.5ml) Group RM- 2ml of 0.75% isobaric ropivacaine + 0.15mg preservative free mo

Sponsors

Lady Hardinge Medical College Associated Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Parturients with PIH posted for caesarean delivery under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1.ASA physical status III & IV and eclampsia 2.Refuse spinal anaesthesia 3.Any contraindication to spinal anaesthesia 4.Patients with obstetric complications like placenta previa, or placental abruption or cord prolapse SAMPLE

Design outcomes

Primary

MeasureTime frame
The mean difference in the hemodynamic effects of intrathecal isobaric ropivacaine and hyperbaric bupivacaine used for caesarean delivery in patients of pregnancy induced hypertension.Timepoint: before giving subarachnoid block,after giving spinal,every 2 min before delivery of baby and then after every 5 min .post operative after every 2 hours till 6hrs after section—

Secondary

MeasureTime frame
Maternal sedationTimepoint: every 15 mins till the end of procedure and postoperatively at 30 mins interval for the first 2 hours and thereafter 2 hourly for 6 hours;Duration of motor blockTimepoint: time to reach modified Bromage scale reaches 1;Duration of postoperative analgesiaTimepoint: post-operative period;Duration of sensory blockTimepoint: regression of anaesthesia below T12 dermatome;Neonatal outcome in terms of Apgar scoreTimepoint: at 1 min and 5 mins after birth;quality of abdominal muscle relaxationTimepoint: at the end of procedure;Respiratory depression, nausea, vomiting and sedationTimepoint: intra-operative and post-operative period;Scale of patient satisfactionTimepoint: end of procedure;time of onset of motor blockTimepoint: every 1 min till complete motor block and then every 15 mins till return of motor function to modified Bromage scale 1.;Time to onset of sensory blockTimepoint: every 1 min till T4/T5 level is achieved, and then every 15 mins during surgery.—

Countries

India

Contacts

Public ContactRuby

Lady Hardinge Medical College & Assosciated Hospitals

ranjusingh1503@yahoo.com9811151285

Outcome results

None listed

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