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Comparison of Levobupivacaine and fentanyl when given in fractionated dose versus when given sequentially for spinal anaesthesia

Intrathecal fentanyl with hyperbaric levobupivacaine 0.5% in fractionated versus sequential dose spinal anaesthesia: Randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068959
Enrollment
70
Registered
2024-06-14
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: PCS- Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Intrathecal fentanyl with hyperbaric levobupivacaine 0.5 % in sequential dose spinal anaesthesia: Drug 2.5 ml of Hyperbaric Levobupivacaine with 25 mcg Intrathecal Fentanyl in sequentia

Sponsors

Rohilkhand Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American society of Anaesthesiologist (ASA) grade I or II 2. Patient undergoing elective infra umbilical surgeries

Exclusion criteria

Exclusion criteria: 1. Patient refusal for the procedure 2. Infection at the site 3. Any abnormality of spine 4. Allergy to local anaesthetics 5. Coagulopathy

Design outcomes

Primary

MeasureTime frame
1. Onset of sensory & motor blockade 2. Highest level of sensory block 3. Time for two segment regression of sensory block 4. Duration of motor blockade 5. Time for first rescue analgesic 6. Incidence of post-operative nausea, vomiting and post spinal shivering. Timepoint: Sensory block will be assessed after 1 minute of injection every 1min until the level is established for four consecutive tests, after that assessment will continue every 10 min until 2 segment regression occurs. The time for motor block from bromage 3 to bromage 2 will be considered as the duration of motor blockade.

Secondary

MeasureTime frame
Hemodynamic parameters (Heart rate, systolic and diastolic blood pressure, mean arterial pressure)Timepoint: During the surgery the patient’s heart rate, Systolic and Diastolic blood pressure, Mean Arterial Pressure, arterial oxygen saturation will be recorded every 5 mins for 30 minutes and then every 10 minutes until completion of the surgery.

Countries

India

Contacts

Public ContactDr Rajat Kumar Agrawal

Rohilkhand Medical College and Hospital

docneehars@gmail.com8077104070

Outcome results

None listed

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