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A CLINICAL TRIAL TO COMPARATIVELY STUDY HYPERBARIC ROPIVACAINE 0.75% AND HYPERBARIC BUPIVACAINE 0.5% FOR SPINAL ANAESTHESIA

COMPARATIVE STUDY OF HYPERBARIC ROPIVACAINE 0.75% AND HYPERBARIC BUPIVACAINE 0.5% FOR SPINAL ANAESTHESIA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048607
Enrollment
60
Registered
2022-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes

Interventions

Intervention1: 0.75% Hyperbaric Ropivacaine: Patients will receive 3ml of intrathecal drug which will include 2.5ml of 0.75% hyperbaric ropivacaine and 25µg (0.5 ml) fentanyl in subarachnoid block for

Sponsors

Dayanand Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18-65 years of either gender scheduled for lower limb surgery under spinal anaesthesia. 2. American Society of Anaesthesiologists (ASA) grade I, II and III.

Exclusion criteria

Exclusion criteria: 1. Patient refusal for subarachnoid block. 2. Allergy to local anaesthetic drugs or any history of anaphylactic reaction to the drugs used. 3. Frank coagulopathy evidenced by history and laboratory investigations. 4. Infection at injection site. 5. Patients with spinal deformities like kyphoscoliosis and scoliosis etc. 6. Patients with history of pre-existing neurological disease. 7. Unable to comprehend sensory and motor block.

Design outcomes

Primary

MeasureTime frame
Duration of sensory block (minutes) measured as the period from intrathecal injection till two dermatome regression.Timepoint: Every 2 minutes for the first 10 minutes and then every 15 minutes till two segment regression

Secondary

MeasureTime frame
1. The onset of sensory block (minutes) - The onset of sensory block will be defined as the time between injection of intrathecal anaesthetic and the absence of pain at T10 dermatome assessed by pinprick testTimepoint: Time to onset of sensory block;2. Maximum level of sensory blockTimepoint: Time to maximum sensory level;3. Time required to achieve maximum level of sensory block (minutes)Timepoint: Time to maximum sensory level;4. Time required for onset of motor block (minutes) - Time for onset of motor block will be defined as the period from intrathecal injection till the MBS is grade 3.Timepoint: Time to onset of motor block;5. Total duration of motor block (minutes) – It is defined as the period from intrathecal injection till complete motor block recovery (MBS- grade 0).Timepoint: Total duration of motor block

Countries

India

Contacts

Public ContactDr Purnima Bhanot

Dayanand Medical College and Hospital

1996purn@gmail.com8146997990

Outcome results

None listed

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