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A clinical trial to compare the effect of post operative pain relief of two different drugs fentanyl and dexmeditomidine as a supplement with bupivacaine in spinal anaesthesia in lower limb ilizarove(reconstructive) surgery.

Comparative study of analgesic effect of intrathecal administration of dexmeditomidine and fentanyl as adjuvants to bupivacaine in lower limb Ilizarov surgeries.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052173
Enrollment
60
Registered
2023-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: M849- Disorder of continuity of bone, unspecified Health Condition 2: M848- Other disorders of continuity of bone

Interventions

Intervention1: Fentanyl: In this group of patients, bupivacaine 15mg (3ml)+ fentanyl 25mcg will be given. Control Intervention1: Dexmeditomidine: In this group of patients, bupivacaine 15mg(3ml) + dex

Sponsors

Dr Dipti Desai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 patient posted for femur/tibia ilizarove surgery for deformity correction,treatment of nonunion,ilizarov in open fracture under spinal anaesthesia only. 2 patient giving verbal conscent. 3 asa 1,2 and 3. 4 both elective and emergency surgery unless contraindicated.

Exclusion criteria

Exclusion criteria: 1 Patients with poor GCS, 2 Patients with renal and liver diseases, 3 Patients with bleeding tendencies and coagulopathy, 4 Patients with known neuropathy, 5 Patients with skin lesions at local site, 6 Patients with local anesthetic allergy, 7 Patients requiring general anaesthesia

Design outcomes

Primary

MeasureTime frame
Comparison of efficacy of both drugsTimepoint: 2hr,4 hr,6hr, 8hr, 10hr,14hr,18hr and 24 hours—

Secondary

MeasureTime frame
To compare safety and haemodynamic stability of both drugsTimepoint: 24 hours—

Countries

India

Contacts

Public ContactDr Dipti Desai

GMERS Medical College Junagadh

drdiptivasani50@gmail.com

Outcome results

None listed

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