Compare effect of fentanyl and tramadol with bupivacaine in spinal anaesthesia for lower abdominal surgeries

Comparative Study Of Efficacy Of Intrathecal Fentanyl Bupivacaine And Tramadol-Bupivacaine Combination With Bupivacaine Normal For Infraumbilical Surgeries: A Double Blind Randomized Control Trial - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070112

Enrollment

120

Registered

2024-07-05

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: O- Medical and Surgical

Interventions

Intervention1: Intrathecal fentanyl and tramadol with bupivacaine: Group F (second group) will undergo Spinal block with Bupivacaine Heavy and Fentanyl, Group T (third group) will undergo Spinal block

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients posted for elective infra-umbilical surgeries (with duration of surgery =2 hours). 2. Age of the patient between 15-70 years. 3. Weight of the patient between 30-70 kg. 4. Patients belonging to ASA class I and II.

Exclusion criteria

Exclusion criteria: 1. Duration of surgery more than 2 hours 2. Patients belonging to ASA class III and IV. 3. Patients with coagulation disorders. 4. Patients with infection at the site of block. 5. Patients with vertebral column deformities, spinal cord deformity, or any neurological deficit 6. Patients with psychiatric disorders. 7. Pregnant patients. 8. Patients with history of hypersensitivity to any of the drugs under study. 9. Patients with uncontrolled hypertension or any decompensated cardiovascular disease.

Design outcomes

Primary

Measure	Time frame
To compare onset and duration of sensory and motor blockade among the groupsTimepoint: as soon as sensory blockade using pin prick is achieved and motor blockade-grade 3 modified bromage scale is achieved	—

Secondary

Measure	Time frame
To compare analgesics in post-operative period over 24hrs in all the groupsTimepoint: till 24hrs after administration of spinal anaesthesia;To compare duration of post-operative analgesia in all the groups. Timepoint: till 24hrs after administration of spinal anaesthesia;To compare the time of first rescue analgesiaTimepoint: till 24hrs after administration of spinal anaesthesia;To observe side effects if any and compare amongst the groups.Timepoint: till 24hrs after administration of spinal anaesthesia	—

Measure

Time frame

To compare analgesics in post-operative period over 24hrs in all the groupsTimepoint: till 24hrs after administration of spinal anaesthesia;To compare duration of post-operative analgesia in all the groups. Timepoint: till 24hrs after administration of spinal anaesthesia;To compare the time of first rescue analgesiaTimepoint: till 24hrs after administration of spinal anaesthesia;To observe side effects if any and compare amongst the groups.Timepoint: till 24hrs after administration of spinal anaesthesia

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Countries

India

Contacts

Public ContactDr Geeta Bhandari

Government Medical College, Haldwani

dr.geetabhandari@gmail.com8650655556

Outcome results

None listed

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