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Use of 2-chloroprocaine by adding fentanyl and dexmedetomidine in short duration orthopaedic surgeries

Comparison of the efficacy of fentanyl and dexmedetomidine as adjuvants to intrathecal 2-chloroprocaine for elective lower limb orthopaedic surgeries- a prospective, randomized, double blind study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026388
Enrollment
60
Registered
2020-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: S80-S89- Injuries to the knee and lower leg

Interventions

Intervention1: SPINAL ANAESTHESIA: 4ml of 2-chloroprocaine Control Intervention1: SPINAL ANAESTHESIA: 4ml of 2-chloroprocaine is added to 25 mcg of fentanyl and 5 mcg of dexmedetomidine

Sponsors

Sri Venkateswara Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of American society of Anesthesiologists physical status grade 1 and 2 2. Patients of age group between 20 to 65 years 3. patients posted for elective lower limb orthopaedic surgeries with duration of 1.5 to 2 hrs

Exclusion criteria

Exclusion criteria: 1. Patients who are not willing to participate in the study. 2. Patients who do not give consent for spinal anaesthesia. 3. H/o spinal surgeries. 4. H/o coagulation and bleeding disorders. 5. Local site infections. 6. H/o hypersensitivity to study drugs. 7. H/o uncontrolled HTN and DM & H/o CAD. 8. Increased serum creatinine and liver enzymes: 2-3 times of normal. 9. H/o neuropsychiatric disorders and communication problems 10. Patients who cannot understand visual analog scale (VAS) measurements. 11. Pregnant women and lactating mothers. 12. Height- 35 Kg/m2.

Design outcomes

Primary

MeasureTime frame
Duration of analgesiaTimepoint: Time of the first analgesic request

Secondary

MeasureTime frame
1.Onset of sensory block 2.Onset of motor block 3.Height of the sensory block 4.Duration of sensory block 5.Duration of motor block 6.Regression time below L1 7.VAS score of pain 8.VAS score of patient satisfaction 9.Adverse hemodynamic effects during the study period Timepoint: 0,3 min, 6 min, 9 min, 12 min, 15 min, 30 min, 45 min, 60 min, 2 hrs, 3 hrs and 4 hrs after injection of study drug.

Countries

India

Contacts

Public ContactMANOJ SANKALA

Sri Venkateswara Institute of Medical Sciences

subhadrapeyyety@gmail.com9493547655

Outcome results

None listed

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