Thish study will Compare the Efficacy of spinal anesthesia by Intrathecal Bupivacaine 0.5% versus Intrathecal 0.75% Ropivacaine in patients undergoing Lower Abdominal and Lower Limb Surgeries
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2022/09/045414
- Lead Sponsor
- Dr Rochana Bakhshi
- Brief Summary
This prospective randomised studywill be conducted in Dr D.Y.Patil hospital & medical college , Navi Mumbai,Department of Anesthesiology, after institutional ethics committee clearance.
The study population will berandomly divided into two groups.
Group 1(SR) ,n=45: will receive3.2ml of 0.75% Ropivacaine heavy
Group 2(SB), n=45: will receive3.2ml of 0.5% Bupivacaine heavy
The patients will be subjected to apreoperative anesthesia check.
Written informed consent willbe obtained before starting any study procedures.
Proper fasting guidelines will beexplained a day prior to surgery.
On the day of surgery Afterchecking the patient’s written informed consent and adequate NBM status, thepatient will be wheeled in operation theatre. The baseline preoperativeparameters would be recorded before inducing anaesthesia. ,intravenous cannula20gauge(G) or 18 gauge will be inserted on the upper extremity.Intravenous fluid ,ringer lactate will be started.
Routine IntraoperativeMonitoring such as
pulse oximeter (SpO2),
electrocardiogram (ECG),
non -invasive blood pressure(NIBP) will be done
Hypotension (20% decrease in MAP),if any, will be treated with intermittent boluses of intravenous ephedrine (6mg)
Bradycardia (HR < 50/ minute)will be treated with intravenous atropine 0.6 milligram (mg) or Glycopyrrolate0.2mg.
Patients will receive spinalanesthesia in sitting position, under aseptic precautions with 25G, Quincketip, spinal needle, by a qualified anesthesiologist.
Group 1 will receive intrathecal3.2 ml of 0.75% Ropivacaine and group 2 will receive intrathecal 3.2ml of 0.5% Bupivacaine.
Patients will be positioned supineimmediately.
Sensory block and level will bechecked using a 25 G hypodermic needle.
Heart rate (HR), systolic (SBP) , diastolic(DBP)and mean arterial pressure (MAP) will be measured every 2 mins from theonset of block for the first 20 mins, thereafter every 10 minutes till the endof the procedure.
**Onset of motor block**will be defined as time frominjection till motor paralysis equivalent to Bromage score 3.
**Duration of sensory block**will be defined as thetime between onset of sensory block to return of touch sensation at L1.
**Duration of motor block**will be defined as thetime between onset of motor block to complete return of motor power (Bromage 0).
**Duration of analgesia** will be defined as the timefrom commencement of block to time when patient first demand rescue analgesia(VAS > 4).
**Pain assessment** will be done by using visual analogue scale
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 90
Patients undergoing lower limb and lower abdominal surgeries 2.
- ASA III & IV 2.
- Patients not consenting for spinal anesthesia 3.
- Spine abnormalities in the patient 4.
- Coagulation disorders 5.
- Patients with recent history of raised intracranial pressure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Onset and duration of motor and sensory block Immediate (Every two minutes for 20 minutes after administration)
- Secondary Outcome Measures
Name Time Method Hemodynamic parameters (SBP, DBP, MAP, HR) Immediate (Every two minutes for 20 minutes after administration) Adverse events From time of administration till wearing off of spinal anesthesia
Trial Locations
- Locations (1)
D Y Patil Medical College and Hospital
🇮🇳Thane, MAHARASHTRA, India
D Y Patil Medical College and Hospital🇮🇳Thane, MAHARASHTRA, IndiaRochana BakhshiPrincipal investigator9323272151drrochana@yahoo.com