To assess the time of onset and efficacy of sensory and motor blockade and post operative pain when two different Adjuvants are added to hyperbaric levobupivacaine for spinal anaesthesia to pregnant patients undergoing caesarean section

Efficacy of Fentanyl and Butorphanol as adjuvant with 0.5% Hyperbaric Levobupivacaine in caesarean section A Randomised Controlled Double Blind Study - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068208

Enrollment

160

Registered

2024-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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 Health Condition 2: Z331- Pregnant state, incidental

Interventions

Intervention1: Butorphanol: Frequency-A single dose Dose-0.5mL(0.5mg)Butorphanol is added to 2ml of 0.5% hyperbaric Levobupivacaine Route-Intrathecal duration of intervention- The assessment of effec

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant females posted for LSCS under spinal anaesthesia ASA-II

Exclusion criteria

Exclusion criteria: Patients not willing to be part of study Contraindications of subarachnoid block Allergy to local anaesthesia Twin pregnancies Polyhydramnios

Design outcomes

Primary

Measure	Time frame
Sensory block(In seconds)Timepoint: The onset of sensory block will be assessed with a pinprick test (using a blunt 25-gauge needle along the mid-clavicular line bilaterally) every 15 seconds from time of subarachnoid block until T6 level achieved.	—

Secondary

Measure	Time frame
1.2 segment regression (in minutes) 2.Duration of sensory block(in minutes) 3.Post operative analgesia(in minutes)Timepoint: 1.The time taken for sensory level to regress to 2 segment below(T8) highest level(T6) will be considered as 2 segment regression for the patient. 2.Duration of sensory block defined as time taken for sensory block to regress 2 segments below from time of subarachnoid block 3.Pain will be assessed by using visual analogue scale (VAS); at 15 minutes 30 minutes and thereafter every 30 minutes till two hours postoperatively and then every hourly, till six hours postoperatively	—

Measure

Time frame

1.2 segment regression (in minutes) 2.Duration of sensory block(in minutes) 3.Post operative analgesia(in minutes)Timepoint: 1.The time taken for sensory level to regress to 2 segment below(T8) highest level(T6) will be considered as 2 segment regression for the patient. 2.Duration of sensory block defined as time taken for sensory block to regress 2 segments below from time of subarachnoid block 3.Pain will be assessed by using visual analogue scale (VAS); at 15 minutes 30 minutes and thereafter every 30 minutes till two hours postoperatively and then every hourly, till six hours postoperatively

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Countries

India

Contacts

Public ContactDr Pramod Patra

Kalinga Institute Of Medical Sciences

pramod.patra@gmail.com9439616053

Outcome results

None listed

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