Ø OBJECTIVES OF RESEARCH:

      GENERAL OBJECTIVE

a.     To compare the intraoperative hemodynamic stability of the three agents and their side effects.

         SPECIFIC OBJECTIVE

a.     To compare the onset of motor and sensory block of three agents.

b.     To compare the duration of motor and sensory block of three agents.

c.     To compare the regression of motor and sensory block of three agents.

 

Ø METHODOLOGY:

     

STUDY   TYPE:  Prospective interventional study

 

STUDY DESIGN:  Randomized and double blinded study

 

STUDY AREA:  The study will be conducted in IQ City Medical College and   

                                Hospital, Durgapur, West Bengal.

 

TIME PERIOD:

Study will be conducted for one year period from November 2022 to October 2023. The first 9 months will be used data collection and the last 3 months will be utilised for data analysis and writing of the thesis.

 

 STUDY POPULATION: 

All adult patients aged between 18-65 years who will be undergoing proximal femur nailing surgery under spinal anaesthesia.

 

 

 

 

 

 

 

SAMPLE SIZE:

Assuming p value less than 0.05 to be significant and considering effect to be two sided we get

 ð‘ð›¼ =1.96; assuming power of our study to be 80% we get 𝑍1−𝛽 = 0.84; considering an effect size (D = difference between the mean of Time (min) for the transition from Bromage score 3) of 4 (from previous study: Spinal anaesthesia: Comparison of plain ropivacaine, bupivacaine and levobupivacaine for lower abdominal surgery) we get the sample size

     

       n ≥ 2 ∗ (𝑍_𝛼 +𝑍_{1−𝛽})² ∗ 𝑆𝐷²

                                 D²

 where SD is the pooled standard deviation.

Thus, we have to take at least 25 patients in each group.

 

Group A (n = 25) – will receive 0.5% Hyperbaric Bupivacaine

Group B (n = 25) – will receive 0.5% Hyperbaric Levobupivacaine

Group C (n = 25) – will receive 0.75% Hyperbaric Ropivacaine

 

 

SAMPLING DESIGN: Simple random sampling

 

DATA COLLECTION AND INTERPRETATION:

·       The study will be conducted after patient allocation and getting permission from Institutional Ethics Committee and approved of the West Bengal University of Health Sciences.

·       We are using three drugs Hyperbaric Bupivacaine, Levobupivacaine, Ropivacaine which are Drug Controller General of India (DCGI) approved.

·       Patient aged between 18 to 65 years of physical status ASA grade 1,2 of either sex, undergoing proximal femur nailing surgery will be included in the study.

·       Preoperative evaluation of the patient will be done on the day before surgery and after explaining the procedure written and informed consent will be obtained.

·       On arrival in the anaesthetic room, routine monitoring with ECG, non-invasive arterial pressure and pulse oximetry will commence and venous access will be secured and an infusion of 500ml Ringer’s Lactated will be started. Spinal anaesthesia will be given in the sitting position using a mid-line approach at third lumbar interspace, that is between L₃ and L₄. A 25g Quincke needle will be inserted with the distal end facing laterally and the appropriate anaesthetic solution will be injected over 10-15sec.

·       Group A will receive 0.3 mg/kg of Hyperbaric Bupivacaine 0.5%, Group B will receive 0.3 mg/kg of Hyperbaric Levobupivacaine 0.5% and Group C will receive 0.3 mg/kg of Hyperbaric Ropivacaine 0.75%. All solutions will be prepared aseptically by the anaesthetist administering the spinal block immediately before injection. The patient will be turned to supine position immediately after injection, the time will be defined as ‘zero’. The principal researchers will not aware about the applying drug.

·       Assessment and monitoring will be done by the investigator who will not be aware of the drugs being administered to the patient.

·       Upper and lower limits of sensory block (analgesia to pinprick using the short bevel end of a 25g intramuscular needle) will be assessed. Caudate limit of sensory block assessment will be S2. The degree of motor block (Modified Bromage Scale: 0-no motor block, 1-inability to raise extended leg, able to bend knee, 2-inability to bend knee, can flex ankle and 3-no movement) will be assessed. Pulse rate and arterial blood pressure will be recorded at 2,5,10,15 and 30 mins and in hourly intervals thereafter.

·       Post operative assessment will be continued in the post operative recovery unit (PACU). Vitals (BP, Pulse rate and Spo2), regression of motor and sensory block and duration of analgesia will be observed and recorded at 30mins intervals until complete regression of motor and sensory block beyond S2 and adverse sequala will be noted and treatment provided. Patients will be encouraged to mobilize carefully under supervision.

 

              PARAMETERS TO BE OBSERVED

·       Pulse rate, systolic, diastolic, mean blood pressure and Spo2 will be recorded at 2, 5, 10, 15 and 30 mins and 1 and 2 hours for the intra operative period

·       Degree of motor block: Degree of motor block will be assessed by Modified Bromage score

                    0-Full movement.

                    1-Inability to raise extended leg, can bend knee.

                    2-Inability to bend the knee but can flex ankle.

                    3-No movements.

·       Duration of sensory block: Defined as the time from intrathecal injection to regression of pinprick sensation to T10 level.

·       Duration of motor block: Defined as the time from intrathecal injection to the regression of motor block to Modified Bromage score 0

·       Adverse effect: Any other adverse effects like hypotension, bradycardia, respiratory depression, drowsiness, nausea, vomiting, pruritis and post Dural puncture headache

S    STUDY VARIABLES: Independent variables                                                     

1.Age

2.Sex

3.BMI

4.Height

5.PT-INR

6.ASA classification

7.Modified Bromage score

8.Comorbidities

9.Intervention

   Bupivacaine, Levobupivacaine, Ropivacaine

 

Dependent Variables

 

1.Heart Rate

2.Blood Pressure

3.Saturation

4.Respiratory Rate

5.Onset

6.Duration

7.Regression

8.Adverse effect

 

INCLUSION CRITERIA:

A. American Society of Anaesthesiologists (ASA) physical status 1 and 2

B. Patient Age 18-65 years.

C. Patient posted for below knee orthopaedic surgery.

D. BMI <30kg/m²

E. Height 4.5 feet to 5.6 feet

EXCLUSION CRITERIA:

A. Patient refusal

B. ASA physical status 3 and 4

C. Immunocompromised patients

D. Local site infection

E. Known allergy to local Anaesthesia

F. Patient’s on anticoagulants medications

EXPECTED OUTCOME OF PROPOSED STUDY

The present study not only will give us a picture of the efficacy of the Hyperbaric Bupivacaine, Levobupivacaine and Ropivacaine after spinal anaesthesia in patients undergoing proximal femur nailing surgery, but will also reflect the intraoperative hemodynamic stability and adverse side effects of the three drugs. Moreover, it will tell us about the choice of local anaesthetic drug for intrathecal anaesthesia in lower limb surgeries.