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

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

Study Overview

• Status: Completed
• Conditions: Haemodynamic Instability
• Intervention / Treatment: Drug: 0.5% Hyperbaric Bupivacaine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74600
      • Dr. Muhammad Wajid Iqbal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Saddle group; 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; 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; Other Names: Hyperbaric Bupivacaine
Active Comparator: Spinal group; After administration of 12mg of 0.5% Hyperbaric Bupivacaine intrathecally, Patient is advised to take Supine position immediately.	Drug: 0.5% Hyperbaric Bupivacaine; 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; Other Names: Hyperbaric Bupivacaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hamdard University
• Investigators: Principal Investigator: Dr. Wajid Iqbal, MBBS, MCPS, Hamdard University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): March 6, 2022
• Study Completion (Actual): March 6, 2022

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: W0333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the study protocol and outcome data will be shared with other researchers in private if the need

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No