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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Duration of analgesia
Study Overview
Brief Summary
This study is to compare the efficacy of fentanyl and dexmedetomidine as an adjuvants to intrathecal 2-chloroprocaine among the patients posted for elective lower limb orthopaedic surgeries.
4ml of 2-chloroprocaine is the study drug in which 25 mcg of preservative free fentanyl is added as an adjuvant in one group and 5 mcg of dexmedetomidine is added in another group.
Study ends when patient complains pain after giving the drug.
onset,duration of sensory and motor block ,height of the sensory block, regression time of L1 dermatome is studied.
Visual Analog Scale(VAS), and Visual analogue Scale of patient satisfaction (VAS scores of patient satisfaction) is used to assess the pain and satisfaction at the drug in patient.
Adverse effects of the study drugs will be studied and manageed during study period .
Our study intends to prove that 2-chloroprocane can be used by adding adjuvants such as fentanyl and dexmedetomidine in short duration lower limb orthopaedic surgeries.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of American society of Anesthesiologists physical status grade 1 and 2
- •Patients of age group between 20 to 65 years
- •patients posted for elective lower limb orthopaedic surgeries with duration of 1.5 to 2 hrs.
Exclusion Criteria
- •Patients who are not willing to participate in the study.
- •Patients who do not give consent for spinal anaesthesia.
- •H/o spinal surgeries.
- •H/o coagulation and bleeding disorders.
- •Local site infections.
- •H/o hypersensitivity to study drugs.
- •H/o uncontrolled HTN and DM & H/o CAD.
- •Increased serum creatinine and liver enzymes: 2-3 times of normal.
- •H/o neuropsychiatric disorders and communication problems
- •Patients who cannot understand visual analog scale (VAS) measurements.
- •Pregnant women and lactating mothers.
- •Height-<140 cm & BMI > 35 Kg/m2.
Outcomes
Primary Outcomes
Duration of analgesia
Time Frame: Time of the first analgesic request
Secondary Outcomes
- 1.Onset of sensory block(2.Onset of motor block)