A comparative study of intrathecal hyperbaric bupivacaine and isobaric levobupivacaine in urological surgeries.
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Onset, Duration, and level of motor and sensory block, motor and sensory regression period.
Study Overview
Brief Summary
After obtainingethical clearance 100 in-patients of Indira Gaandhi Institute of MedicalSciences, Patna belonging to ASA I and II posted for elective urologicalsurgeries will be included in this study.
Pre-anaestheticcheckup will be done for all patients and written informed consent will betaken. On the day of surgery, patients will be shifted to the operation theatre with an 18 G IV cannula secured and theywill be preloaded with Ringer Lactate 10ml/kg approximately 20 minutes prior tothe administration of spinal anaesthesia.
Non invasiveblood pressure monitor, pulse oximeter and ECG leads will be connected for allpatients and baseline values will be recorded. Supplementary oxygen will beprovided at the rate of 5 litres/min via a face mask.
Under strictaseptic precautions 2.5ml of the study drug will be loaded by ananaesthesiologist not involved in the study. Therefore, the patient and theanaesthesiologist performing the spinal block and recording the intraoperativeand postoperative data will be blinded. The study drug will be injected intoL3-L4 sub arachnoid space using 26G whitacre spinal needle after confirming freeflow of cerebrospinal fluid and the time of injection will be recorded as 0minutes. Following this the patients will be made to lie supine immediately .Surgery will commence after loss of sensation to pinprick at T6 level.
Followingparameters will be noted:
Onset of sensory block–Time taken from injection of study drug ( 0 minutes) to loss of sensation to pin-prick at T6 level. It will be tested using ablunted 24G hypodermic needle bilaterally in the mid-clavicular line every 2minutes.
Maximum sensory block attained– Timetaken from injection of study drug (0 minutes ) till the patient attains lossof sensation at the highest dermatome in 10 minutes.It will be tested every 2minutes using a blunted 24 g hypodermic needle bilaterally in mid-clavicularline for the first 10 minutes.Time taken to reach the highest level of blockwill be recorded.
Duration of sensory block– Timetaken from maximum block height attained till regression of block to T10dermatome. It will be tested at the end of surgery using a 24G hypodermicneedle bilaterally in mid-clavicular line.
Onset of motor block–Timetaken from injection of study drug ( 0 minutes ) till the patient attainsBromage 2.It will be tested using modified Bromage scale every 2 minutes.
Maximum motor block attained– Timetaken from injection of drug ( 0 minutes ) till the patient attains maximummotor block.It will be tested every 2 minutes for the first 10 minutes.Timetaken to attain the maximum motor block score in 10 minutes will be recorded.
Duration of motor block– Timetaken from maximum Bromage score attained to Bromage 0.It will be tested at theend of surgery using modified Bromage scale.
Hemodynamicchanges- Heart rate, systolic and mean arterial pressure andoxygen saturation will be recorded every 5 minutes till the completion ofsurgery and every 10 minutes postoperatively till the regression of sensory and motor block.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients undergoing elective urological surgery under spinal anaesthesia.
- •Aged between 30-60 years.
- •ASA grade 1 &
- •Those who are willing to give written consent.
Exclusion Criteria
- •persons with pre existing renal, cardiovascular,hepatic or other systemic diseases.
- •bleeding diathesis.
- •infection at the site of block 4)abnormalities of spine 5)Aspirin ingestion in preceeding week.
Outcomes
Primary Outcomes
Onset, Duration, and level of motor and sensory block, motor and sensory regression period.
Time Frame: time to reach t-9 sensory level will be taken as onset time.time to 1st rescue analgesic after surgery will give duration of analgesia. level of block will be assessed every 5 minutes till 30 minutes after block. motor and sensory regression will be assessed every 15 minutes post-operatively.
Secondary Outcomes
- any adverse effect like nausea, vomiting, hypotension, bradycardia or breathing difficulty.(hypotension, bradycardia will be assessed every 5 minutes intra-operatively and every 15 minutes post-operatively. other adverse effects will be recorded if occurs any time intra operatively and post operatively till the regression of sensory block.)