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Comparison of Sensory and Motor Block Efficacy at Different Reverse Trendelenburg Angles in Patients Undergoing Spinal Anesthesia with Heavy Marcain

Protocol summary

Study aim
In this study, the sensory and motor blockade effects of hyperbaric bupivacaine applied to patients undergoing anorectal surgery were compared in reverse trandelenburg position at 0, 10, 30, 50, 70 and 90 degree back angles.
Design
Heavy bupivacaine is frequently used in the surgical field for subarochnoid block. While bupivacaine is the 0.5% plain form that does not contain dextrose, the hyperbaric form is the form that emerges with the addition of glucose (80 mg/ml) to plain bubivacaine. The effectiveness of hyperbaric bupivacaine has been studied in many studies, and the sensory block pattern has been observed to be more predictable in hyperbaric bupivacaine than in bupivacaine. Another difference between hyperbaric and plan bupivacaine is the nature and duration of motor block.
Settings and conduct
All patients were given 7 ml/kg 0.9% NaCl preoperatively. During the operation, patients underwent electrocardiography, non-invasive blood pressure and pulse-oximetry monitoring. With spinal anesthesia in a sitting position, a 25-gauge (G) pencil-tipped spinal needle (BD Quincke) was administered to the lumbosacral region and 2 cc (10 mg) hyperbaric bupivacaine was administered to the subarachnoid space from the L3-4 space.
Participants/Inclusion and exclusion criteria
ASA (American Society of Anesthesiologists) I-II patients, aged between 18-50, who were planned for elective anorectal surgery, were included in the study. Patients who were morbidly obese, used anticoagulants or salicylates, had coagulation disorders, or had psychiatric or neurological problems were not included in the study.
Intervention groups
6 groups, 150 patients
Main outcome variables
In this study, the sensory and motor blockade effects of hyperbaric bupivacaine applied to patients undergoing anorectal surgery were compared in reverse trandelenburg position at 0, 10, 30, 50, 70 and 90 degree back angles.

General information

Reason for update
Acronym
Comparison of Sensory and Motor Block Efficacy
IRCT registration information
IRCT registration number: IRCT20240204060903N1
Registration date: 2024-02-24, 1402/12/05
Registration timing: retrospective

Last update: 2024-02-24, 1402/12/05
Update count: 0
Registration date
2024-02-24, 1402/12/05
Registrant information
Name
yücel özgür
Name of organization / entity
Istanbul Bahcelievler State Hospital
Country
Turkey
Phone
+90 505 524 21 40
Email address
yucelozgur19@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-10, 1402/11/21
Expected recruitment end date
2024-02-12, 1402/11/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sensory and Motor Block Efficacy at Different Reverse Trendelenburg Angles in Patients Undergoing Spinal Anesthesia with Heavy Marcain
Public title
Comparison of Sensory and Motor Block Efficacy at Different Reverse Trendelenburg Angles in Patients Undergoing Spinal Anesthesia with Heavy Marcain
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
ASA (American Society of Anesthesiologists) I-II, 150 patients between the ages of 18-55 who are scheduled for elective anorectal surgery will be included in the study.
Exclusion criteria:
Patients who do not want to participate in the study will not be included in the study. Patients who use blood thinners and are pregnant will not be included in the study.
Age
From 18 years old to 55 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 150
More than 1 sample in each individual
Number of samples in each individual: 25
10 mg heavy bupivacaine will be administered to all groups in the subarochnoid space. There will be different angles in 6 groups
Randomization (investigator's opinion)
Randomized
Randomization description
People will be randomly divided into 6 groups. Working in groups will be done according to the plan according to the selected angle. Patients are randomly divided into groups. While patients are included in the groups, a blind evaluation will be made.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
People will be randomly divided into 6 groups. A study is planned in 150 patients.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bakırkoy Dr. Sadi Konuk Traınıng And Research Hospıtal| Clınıcal Studıes Ethıcs Commıttee Decısıon
Street address
Bahçelievler Mah Saklıvadi Sok. Ağaoğlu Mycity 30B2 D29
City
Bahçelıevler
Postal code
34180
Approval date
2023-06-05, 1402/03/15
Ethics committee reference number
245

Health conditions studied

1

Description of health condition studied
Istanbul Bahcelievler State Hospital
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
As a result of spinal anesthesia, block levels will vary depending on the patient's back angle.
Timepoint
Results will be collected from patients within 2 hours.
Method of measurement
The level of spinal block will be evaluated by cold test and pinprick test.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Patients in this group will be at 10, 30, 50, 70 and 90 degrees. 10 mg heavy marcain will be administered into the spinal space. Heavy bupivacaine is frequently used in the surgical field for subarachnoid block. While bupivacaine is a 0.5% plain form that does not contain dextrose, the hyperbaric form is the form that occurs with the addition of glucose (80 mg/ml) to plain bubivacaine. The effectiveness of hyperbaric bupivacaine has been studied in many studies, and the sensory block pattern has been observed to be more predictable in hyperbaric bupivacaine than in bupivacaine. Another difference between hyperbaric and plan bupivacaine is the nature and duration of the motor block. Hyperbaric bupivacaine generally has a safer level of effectiveness than bupivacane. In studies, the effectiveness of hyperbaric bupivacaine and other local anesthetic agents has been compared at different doses and in different surgeries, but no study comparing their effectiveness according to different angles in the supine reverse trandelenburg position of the patient has been found in the literature.The standard spinal anesthesia approach in anorectal surgery is performed in a sitting position and frequently with the application of hyperbaric bupivacaine. The applied doses are generally between 5-10 mg. Hyperbaric bupivacaine provides long-term pain relief in the postoperative period.
Category
Treatment - Surgery

2

Description
Control group: Patients in this group will be at 0 degrees. 10 mg heavy marcain will be administered into the spinal space.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Istanbul Bahçelievler State Hospital, Türkiye
Full name of responsible person
Yücel Özgür
Street address
Bahçelievler District
City
Istanbul
Postal code
34180
Phone
+90 505 524 21 40
Email
anstz@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Istanbul Bahçelievler State Hospital, Türkiye
Full name of responsible person
yücel özgür
Street address
Bahçelievler District
City
ıstanbul
Postal code
34180
Phone
+90 505 524 21 40
Email
anstz@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Istanbul Bahçelievler State Hospital, Türkiye
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Istanbul Bahçelievler State Hospital
Full name of responsible person
Yücel Özgür
Position
Anesthesiology and Reanimation Clinic
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahçelievler District Saklıvadi Street Ağaoğlu Mycity 30B2 D29
City
Bahçelievler
Province
Istanbul
Postal code
34180
Phone
+90 505 524 21 40
Email
anstz@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Istanbul Bahçelievler State Hospital
Full name of responsible person
Şenel Altun
Position
Cardiovascular Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Bahçelievler District
City
Bahçelievler
Province
İstanbul
Postal code
34180
Phone
+90 505 524 21 40
Email
altunsenel@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Istanbul Bahcelievler State Hospital
Full name of responsible person
Yücel özgür
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahçelievler mah saklıvadi sok. ağaoğlu mycity 30B2 D29
City
Bahçelievler
Province
İstanbul
Postal code
34180
Phone
+90 505 524 21 40
Fax
Email
yucelozgur19@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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