A comparative study of the effect of intrathecal Fentanyl and Buprenorphine as an adjuvant to 0.5% Hyperbaric Bupivacaine for infraumbilical surgeries under spinal anaesthesia: A Randomised Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- To compare the duration of analgesia between the study groups
Study Overview
Brief Summary
This prospective, randomized, double blinded study study will be conducted in the Department of Anesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur. The study will involve 120 patients scheduled for infraumbilical surgeries with intrathecal injection of either 3ml of 12.5 milligram of 0.5 percent hyperbaric bupivacaine with fentanyl 25 microgram or 3ml of 12.5 milligram of hyperbaric bupivacaine with 150 microgram of Buprenorphine. The patients will be randomly divide into two groups of 60 each. Group BF will receive 3ml of 12.5 mg of 0.5 percent hyperbaric bupivacaine with Fentanyl of 25 microgram and Group BB will receive 3ml of 12.5 milligram of 0.5 percent hyperbaric Bupivacaine with 150 microgram of Buprenorphine injected intrathecally. The quality of surgical anesthesia, motor and sensory blockades, hemodynamic changes, duration of the analgesia as well as the side effects will be noted for the two groups. All the findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analyzed and inference will be drawn to evaluate and compare the two drugs with their clinical advantages and side effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 18 to 60 years of either sex undergoing spinal anaesthesia for elective infraumbilical surgeries, such as surgical procedures on lower abdomen, genitourinary region including gynaecological and urological surgeries
- •Patients of American Society of Anaesthesiologists (ASA) grade 1 or 2
- •Either sex.
Exclusion Criteria
- •Pregnancy and lactation
- •Uncooperative patient and patient refusal to give consent
- •Patient with history of allergy to the drugs(hyperbaric Bupivacaine, Fentanyl, Buprenorphine)
- •Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled thyroid disorder, height more than 180 cm or height less than 140 cm and weight more than 110 kgs or weight less than 45 kgs
- •Patients with cardiovascular, respiratory, renal, hepatic or neurological disease
- •Patients contraindicated for spinal anesthesia such as local site infection, spinal deformity, patient with bleeding disorder-platelet count more than 50000/microliter, prothrombin time ore than 14 seconds, INR more than 1.5.
Outcomes
Primary Outcomes
To compare the duration of analgesia between the study groups
Time Frame: After the intrathecal injection, parameters as per the protocol will be recorded every 2 minutes for the first 10 minutes and every 5 minutes till 30 minutes and every 10 minutes till 60 minutes and every 30 minutes till 180 minutes
Secondary Outcomes
- 1. To compare the onset time of sensory & motor block between the the two groups(2. To assess the duration of sensory & motor block achieved with each adjuvant)
Investigators
Takhellambam Shamananda Singh
Regional Institute of Medical Sciences