Comparison of effectiveness and hemodynamic stability of saddle block versus spinal anaesthesia using Levobupivacaine with Fentanyl as an adjuvant in Transurethral resection of prostate surgery A randomised comparative study

AIM OF STUDY

Comparison of effectiveness & hemodynamic parameters (Pulse, Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP)) between saddle block and spinal anaesthesia in transurethral resection of prostate (TURP).

 OBJECTIVES

Primary Objectives:

•        Evaluate and compare the hemodynamic parameters between spinal block and saddle block.

Secondary Objectives:

•        Vasopressor requirement on administering either subarachnoid block or saddle block

•        Time to achieve maximum level of sensory blockade

•        Time to achieve maximum level of motor blockade

•        Post operative pain assessment (NRS-Numerical rating scale)

•        To observe any complication (Bradycardia, Hypotension, Shivering, Nausea, Vomiting, Pruritus, Urinary retention)

 STUDY PROTOCOL

Ethical consideration: This study will be conducted after getting approval from local ethical committee of GMERS Medical College and Hospital, Gotri, Vadodara. It will be registered with Clinical Trial Registry of India(CTRI). Written and Informed consent will be taken from all participants. Data collected will be kept confidential. The study will be conducted following the principles of Helsinki declaration.

Study design: Randomized controlled study

Study setting: Tertiary care teaching hospital (GMERS Medical college and Hospital, Gotri, Vadodara)

Study duration: Approx. 6 months

Study population: patients posted for Transurethral Resection of Prostate(TURP) in surgical unit.

Inclusion criteria

•        Age:60-80 years

•        Weight:50-80 Kg

•        Height:150-170cm

•        American society of anaesthesia grading (ASA): I, II, III,

•        prostatic volume of 30-80 cc

•        Surgical duration-60-90 mins

 Exclusion criteria

•        Refusal to enrol in study

•        Local site infection

•        H/o allergy to local anaesthetic

•        Psychiatric or neurologic illness (Alzheimer’s, Schizophrenia, etc.)

•        Deformity of vertebral column

•       Coagulation disorder

METHODOLOGY

Pre-operative assessment and selection of Patients: A thorough pre-operative assessment of the patients posted for TURP surgery under spinal anaesthesia will be carried out and the details will be recorded in the proforma.

History will be taken regarding present and past complaints, personal history, medication history, history of previous anaesthesia exposure, blood transfusions, jaundice, pedal edema, convulsion etc.

General and systemic examination will be done.

Routine investigations will be sent according to standard guidelines and specific investigations will be carried out as and when indicated.

On arrival in the operating room, each patient will be identified and then placed on a tilting operating table, routine non-invasive monitor will be applied. Baseline pulse rate, ECG, respiratory rate, blood pressure (SBP, DBP & MAP) and oxygen saturation will be recorded.

After securing 18 G or 20 G intra venous line, intravenous fluid (Inj.NS) will be started.

Under all aseptic & antiseptic precautions spinal anaesthesia will be given in L3–L4 intervertebral space in sitting position in all cases. 23G Quincke’s spinal needle will be inserted. Both Groups will receive 2 cc of Inj Levobupivacaine heavy 0.5%(10mg) + 0.5 cc of Inj Fentanyl(25 mcg).Drugs will be given after free and clear flow of Cerebrospinal Fluid.

Group SAB-Immediately after the injection, patients will be positioned supine        with one pillow beneath their head.

Group SB-After administering the drug, patients will be kept in the sitting position for the next 10 min and then will be positioned supine with one pillow beneath their head.

Data Collection

•        Time of complete drug administration in the Subarachnoid space will be taken as T0.

•        Hemodynamic parameters like pulse, SBP, DBP, MAP will be recorded every 3 min for the first 15 min, every 5 min for next 15 min, and then every 10 min until the end of surgery.

•        Clinically relevant hypotension (decrease in MAP >20% of baseline) will be treated with a bolus of 6 mg Mephentermine.

•        The level of sensory blockade will be measured bilaterally using pin prick test at 3, 5, 10, 30, 45, 60, and 120 min after injection.

•        The level of motor blockade will be assessed using the Modified bromage scale. The assessment of the motor blockade will be done at 10 and 120 min after injection.

•        Modified Bromage Scale

Bromage 1 = Complete block (unable to move feet or knees)

Bromage 2 = Almost complete block (able to move feet only)

Bromage 3 = Partial block (just able to move knees)

Bromage 4 = Detectable weakness of hip flexion (between score 3 and 5)

Bromage 5 = No detectable weakness of hip flexion while supine (full flexion of knees)

Bromage 6 = Able to perform partial knee bend

•        Time to reach maximum sensory block, maximum motor block, operation time and perioperative complications if any, will also be recorded.

•        The inability to achieve a sensory blockade up to T10 dermatome will be considered as a failed block and will be excluded from study.

•        in case of a failed block with no sensory or motor blockade patient will be then induced under general anaesthesia as per institutional protocol.

  STATISTICAL ANALYSIS

Data will be analyzed using appropriate statistical tests to determine signiificant differences between the two groups. A p-value of <0.05 will be considered statistically significant.

 OUTCOME MEASURES

Primary outcome

•        Comparison of hemodynamic parameters (pulse, SBP, DBP, MAP) in between the two groups

Secondary outcome

•        Difference in time to achieve level of sensory block in both the groups

•        Difference in time to achieve level of motor block in both the groups

•        Duration of analgesia

•        Record any complications