Effect of different doses of local anaesthetics in cesarean section on mother and newborn under spinal Anesthesia

A study to evaluate fetomaternal outcome with varying doses of hyperbaric levobupivacaine and fentanyl as an adjuvant in cesarean section under spinal anaesthesia - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056622

Enrollment

105

Registered

2023-08-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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: Spinal Anaesthesia: Group A will be receiving 7.5 mg hyperbaric levobupivacaine 0.5% plus 25Î¼g of fentanyl intrathecally diluted upto 2.5ml. Group B will be receiving 8.5 mg hyperbaric

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective LSCS. 2. Patients American Society of Anaesthesiology(ASA) Grade II. 3. Patients having height >150cm 4. Patients having period of gestation equal to or above 35 weeks, with a live singleton foetus.

Exclusion criteria

Exclusion criteria: 1. Patient given refusal for study 2. Patient with absolute contraindication for subarachnoid block (spinal deformity, local sepsis). 3. Patient with Cardiorespiratory problems. 4. Patient with Coagulation disorder. 5. Patient with Neurological disease 6. Patient with Psychological disease 7. Patient with Endocrine disease and allergy to used drugs

Design outcomes

Primary

Measure	Time frame
To compare the mean arterial pressure in parturient & apgar score in neonate following the administration of varying doses of hyperbaric levobupivacaine along with fentanyl as an adjuvant intrathecally. Timepoint: from the time of giving spinal anaesthesia till 24 hours postoperatively	—

Secondary

Measure	Time frame
To evaluate : 1 Onset, duration of sensory & motor blockade 2 Neonatal outcome using cord blood pH 3 Patientâ??s & surgeonâ??s satisfaction score. 4 Duration of postoperative analgesia 5 Doses of rescue analgesia required in 24 hours. 6 Time to breastfeeding & ambulation 7 Any complications related to procedures or side effect of any drug. Timepoint: from the time of giving spinal anaesthesia till 24 hours postoperatively	—

Measure

Time frame

To evaluate : 1 Onset, duration of sensory & motor blockade 2 Neonatal outcome using cord blood pH 3 Patientâ??s & surgeonâ??s satisfaction score. 4 Duration of postoperative analgesia 5 Doses of rescue analgesia required in 24 hours. 6 Time to breastfeeding & ambulation 7 Any complications related to procedures or side effect of any drug. Timepoint: from the time of giving spinal anaesthesia till 24 hours postoperatively

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Countries

India

Contacts

Public ContactDr Gagnjot Kaur

Sri Guru Ram Das Institute of Medical Sciences and Research

geetsaini7997@gmail.com9877181967

Outcome results

None listed

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