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

Phase 3

Completed

• Conditions: Haemodynamic Instability
• Interventions: Drug: 0.5% Hyperbaric Bupivacaine

• Registration Number: NCT05285800
• Lead Sponsor: Hamdard University

Brief Summary

To determine the effectiveness of saddle block vs spinal anesthesia in TURP.

Detailed Description

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

Study Timeline

• Study Start: 2021-09-06
• Status Verified: 2022-03
• Primary Completion: 2022-03-06
• Study Completion: 2022-03-06
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-18
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saddle group	0.5% Hyperbaric Bupivacaine	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
Spinal group	0.5% Hyperbaric Bupivacaine	After administration of 12mg of 0.5% Hyperbaric Bupivacaine intrathecally, Patient is advised to take Supine position immediately.

Primary Outcome Measures

Name	Time	Method
Haemodynamic status	Haemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery.	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.
Vasopressor usage	Blood pressure is taken from 0minute (as the patient takes supine position) at every ⁵minutes interval till the end of surgery	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.

Trial Locations

Locations (1)

Dr. Muhammad Wajid Iqbal; 🇵🇰 Karachi, Sindh, Pakistan