A prospective study to compare the efficacy of bolus dose versus fractionated dose injection of hyperbaric bupivacaine with dexmedetomidine in spinal anaesthesia among adult patients undergoing lower limb surgery

A PROSPECTIVE STUDY TO COMPARE THE EFFICACY OF BOLUS DOSE VERSUS FRACTIONATED DOSE INJECTION OF HYPERBARIC BUPIVACAINE WITH DEXMEDETOMIDINE IN SPINAL ANAESTHESIA AMONG ADULT PATIENTS UNDERGOING LOWER LIMB SURGERY

Aim

To compare the efficacy of bolus dose versus fractionated dose injection of hyperbaric bupivacaine with dexmedtomidine in spinal anaesthesia among adult patients undergoing lower limb surgery.

OBJECTIVES

1.  To compare the onset of sensory and motor blockade in fractional spinal anaesthesia and conventional spinal anaesthesia and the highest level of sensory block achieved in both groups.

 2.    To compare the duration of sensory and motor block in both the groups

 3  .  To compare the changes in Heart Rate,Blood Pressure & Saturation between the groups.

 4.   To compare duration of analgesia in both the groups

INCLUSION CRITERIA:·       Patient willing to sign the written informed consent.

·       Patients belonging to American Society of Anaesthesiologists (ASA) Grade I or II.

·       Male or female patients between age range of 18- 60 years.

·       Patients undergoing elective lower limb surgeries under spinal anaesthesia

 EXCLUSION CRITERIA:·      Patients unwilling to participate in the study.

·      Patient having arryhthmia or heart block.

·      Patients with renal, hepatic, cardiovascular and respiratory diseases.

·      Patients belonging to ASA Grade III or more.

·      Pregnant or lactating women.

·      History of known allergy to study drug.

·      Patients who needs supplementation of general anaesthesia.

·             Any contraindication  to spinal anaesthesia (local site infection , coagulation disorder , raised intracranial pressure , hemodynamic instability, neurological disorders).

Patients will be randomly allocated using computer generated random numbers into 2 groups ; Group B And Group F of 30 patients each . In both groups the total volume of drug administered during spinal anaesthesia will be 3.8ml [3.7ml (18.5mg) of 0.5% hyperbaric bupivacaine + 0.1ml (10mcg) of dexmedetomidine.]

Group B:- Patients will be administred single bolus dose of 3.8ml Of spinal drug.

Group F:- Patients will be administered fractionated dose Of 3.8ml i.e 2/3 rd of total dose - 2.5ml will be given initially and

after 90sec remaining 1/3rd of total dose i.e. 1.3ml will be given.

All patients of both groups will be monitored for:

HR, SBP, DBP, MAP, SPO2, , will be monitored at 1min, 3min, 5 min, 10 min,

15 min and thereafter every 15 minutes upto 90 minutes and then every 30 minutes till the end of surgery.

Sensory block will be assessed at 2 minute interval until two consecutive levels of sensory block will be identical (i.e fixation of the level); which will be taken as the highest level of sensory block. After this, assessment of sensory block will be

done every 30 minutes till level regresses to L1.

Onset of motor block of drug (time from intrathecal injection till achievement of Bromage Score 1) and duration of motor block

(time from intrathecal injection of drug to return of Bromage Score to 0) will be recorded.

VAS will be assessed every 30min for 2 hours and then every hourly till VAS becomes ≥4

Site of Study: Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat.

Study Duration- The study will be completed within 18 months after obtaining the approval from institutional ethics committee .

Study Design**-** Prospective, Observational Study.

statistical method - data collected will be tabulated. Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percent. As regard to numerical variables; tests like unpaired student – t test and or ANOVA will be used whenever appropriate for between- groups comparisons, while for categorical variables; chi – square test will be used. p value<0.05 will be considered statistically significant.

LIKELY OUTCOME/BENEFITS OF STUDY The study will help us to know which method of spinal anaesthesia,will provide better hemodynamical stability,longer duration of sensory and motor block and provides longer post operative analgesia in patient undergoing lower limb surgery.