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

Sponsor
Hamdard University (Other)
Overall Status
Completed
CT.gov ID
NCT05285800
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
5.9
Actual Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.5% Hyperbaric Bupivacaine
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
In Both the groups after injecting 0.5% hyperbaric Bupivacaine intrathecally the outcomes are monitored and compared.In Both the groups after injecting 0.5% hyperbaric Bupivacaine intrathecally the outcomes are monitored and compared.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP
Actual Study Start Date :
Sep 6, 2021
Actual Primary Completion Date :
Mar 6, 2022
Actual Study Completion Date :
Mar 6, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Vasopressor usage [Blood pressure is taken from 0minute (as the patient takes supine position) at every āµminutes 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Muhammad Wajid Iqbal Karachi Sindh Pakistan 74600

    Sponsors and Collaborators

    • Hamdard University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Muhammad Wajid Iqbal, Resident medical officer, Anesthesiology, Hamdard University
    ClinicalTrials.gov Identifier:
    NCT05285800
    Other Study ID Numbers:
    • W0333
    First Posted:
    Mar 18, 2022
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bupivacaine

    Study Results

    No Results Posted as of Mar 31, 2022