injection of anesthetic medicine in fraction versus in single bolus for lower limb and lower abdominal surgeries
- Conditions
- patients posted for lower abdominal and lower limb surgeries
- Registration Number
- CTRI/2018/04/013184
- Lead Sponsor
- Shilpa Bhimasen Joshi
- Brief Summary
Afterethical committee approval and informed consent, patients will be recruited forthe study. Preoperative evaluation is doneand the subjects will be randomized via computergenerated table and allocated to one ofthe groups. Group B: 3.6 ml of 0.5% hyperbaric Bupivacaine,Group F : 3.6 ml of 0.5% hyperbaric Bupivacaine in fractionatedapproach. Demographic details (Age,sex, weight, ASA status, height) will be noted.
Asa standard practice, pre-operatively patients will be kept fasting for 6 hours.They will be routinely premedicated with Tab. Alprazolam 0.5 mg and Tab.Pantoprazole 40 mg on the night prior to surgery and on the morning ofsurgery.
Intraoperativelypatients will be monitored by electrocardiography, non-invasive blood pressureand pulse oximetry. In group B - Spinalanesthesia will be given with 3.6cc of 0.5% heavy Bupivacaine at L3-4interspace via 25 G spinal needle, with subject in the sitting position . In group F - Spinalanesthesia of 3.6cc of 0.5% heavyBupivacaine at L3-4 interspace via 25 G spinal needle will be given in afractionated approach where 2.4cc(2/3rd) will be given first andthen the remaining 1.2ml (1/3rd) will be given after 120sec.Thesubject will made to lie supinesoon after the injection. At 5 mins after theinjection, level of block –sensory by pinprick and motor by bromage scale willbe checked. This will be considered asonset of sensory and motor block. At20min, the peak level of sensory and motor block willalso be noted.
Theduration of spinal anesthesia is considered as two segment regression from the level of sensory block achieved at 20min(peak) of sensory block . At the endof surgery, both the sensory level and motor block will be rechecked. Vitalssuch as Heart rate (HR), Systolic blood pressure (SBP), Diastolicblood pressure (DBP), Mean arterial blood pressure (MAP), saturation (SpO2)will be measured at every 5 mins for 1sthourand then 10min till the end of surgery.
Anyside effects of the spinal anesthesia such as: Bradycardia (HR < 20% ofbaseline), Hypotension (BP < 25% of baseline), Respiratory depression,Sedation, Pruritis and Nausea/ Vomiting will be noted and treatedappropriately. Bradycardia will be treated with Injection Atropine 20mcg/kg IVand Hypotension by IV fluids/ injection Mephentermine 3 mg IV boluses.
Thedata will be collected in the study proforma and analyzed for statisticalsignificance with the statistician.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
ASA I-II patients undergoing lower abdominal or lower limb surgery under spinal anesthesia.
a)Patient refusal b)Allergy to Bupivacaine c)Body mass index (BMI) > 35 d)Intra-operative conversion to general anesthesia (GA) / inadequate or failed spinal block e)Pregnant and lactating mothers f)Known bleeding diathesis or with any coagulation abnormalities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the onset, peak and duration of sensory and motor block in fractionated and single bolus dose of spinal anesthesia with 0.5% heavy bupivacaine for lower abdominal and lower limb surgeries. 5,10,15,20,25,30,60,90,120,150,180,210 minutes after spinal injection
- Secondary Outcome Measures
Name Time Method 1)To compare the intraoperative hemodynamics heart rate, saturation,systolic blood pressure, diastolic blood pressure, mean blood pressure and any side effects
Trial Locations
- Locations (1)
St Johns Medical College
🇮🇳Bangalore, KARNATAKA, India
St Johns Medical College🇮🇳Bangalore, KARNATAKA, IndiaShilpa Bhimasen JoshiPrincipal investigator9901405136drshilpa.josh@gmail.com