To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP

Study Overview
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Brief Summary
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To determine the effectiveness of saddle block vs spinal anesthesia in TURP.

Detailed Description
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This study is being conducted to determine the effectiveness of saddle block vs spinal anesthesia in terms of haemodynamic stability and Vasopressor usage.

Official Title
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To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP

Conditions
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Haemodynamic Instability

Intervention / Treatment
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* Drug: 0.5% Hyperbaric Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with absolute contraindication of general anaesthsia Patients who gave consent and willing to be included in study Patient's having age range between 45 years to 65years Well controlled diabetes and hypertension ASA grade I & II Exclusion Criteria: Patients with absolute contraindications of regional anesthesia, Deformity of vertebral column, Thyroid disorder, Psychiatric illness, Neurological diseases, Alcohol addiction, Smoking, Ischemic heart diseases and Not willing to participate

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In Both the groups after injecting 0.5% hyperbaric Bupivacaine intrathecally the outcomes are monitored and compared.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saddle group<br>After administration of 12mg of 0.5 % Hyperbaric Bupivacaine intrathecally, Patient is advised to remain in Sitting position for the next 5minutes and then take supine position | Drug: 0.5% Hyperbaric Bupivacaine<br>* In both groups 0.5% Hyperbaric Bupivacaine is given intrathecally and then saddle group is advised to stay in sitting position for next 5minutes so that drug can block only lower segments of nerves, Lumber 5th to Sacral dermatomes level. The spinal group is advised to take supine position immediately so that drug distribution be uniform uptill T10 level of spinal dermatome. Then outcomes regarding haemodynamic status and vasopressor usage are recorded<br>* Other names: Hyperbaric Bupivacaine;|
| Active Comparator: Spinal group<br>After administration of 12mg of 0.5% Hyperbaric Bupivacaine intrathecally, Patient is advised to take Supine position immediately. | Drug: 0.5% Hyperbaric Bupivacaine<br>* In both groups 0.5% Hyperbaric Bupivacaine is given intrathecally and then saddle group is advised to stay in sitting position for next 5minutes so that drug can block only lower segments of nerves, Lumber 5th to Sacral dermatomes level. The spinal group is advised to take supine position immediately so that drug distribution be uniform uptill T10 level of spinal dermatome. Then outcomes regarding haemodynamic status and vasopressor usage are recorded<br>* Other names: Hyperbaric Bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic status | Haemodynamic status includes pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation. Pulse rate ranges between 60-100 beats/ minute. Pulse above 100 is called tachycardia and below 60 is called bradycardia Systolic blood pressure more than 140mmhg is called systolic hypertension and lower than 90mmhg is known as systolic hypotension. Diastolic blood pressure more than 90mmhg is called diastolic hypertension and lower than 60mmhg is called diastolic hypotension. Mean arterial pressure ranges between 70-110. More than 110 labeled as hypertension and below 70 means hypotension. Spo2 level below 94% is labeled as hypoxia. | Haemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery. | 
| Vasopressor usage | The main side effect of intrathecal 0.5 % hyperbaric Bupivacaine is hypotension. That is countered by using vasopressor drug e.g inj. Ephedrine. Critically low blood pressure e.g systolic bp below 90mmhg, diastole c blood pressure below 60mmh and MAP below 60 is an indication for vasopressor introduction. | Blood pressure is taken from 0minute (as the patient takes supine position) at every ⁵minutes interval till the end of surgery |