Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000061538p
Ethics application status
Not yet submitted
Date submitted
26/05/2023
Date registered
25/01/2024
Date last updated
25/01/2024
Date data sharing statement initially provided
25/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Hyperbaric bupivacaine dose according to Modified Harten’s chart v.s a fixed dose of Hyperbaric bupivacaine for spinal anesthesia in non pregnant patients
Scientific title
RCT: a Comparison between a fixed intrathecal dose of 0.5% Hyperbaric Bupivacaine, and tailored intrathecal dose of 0.5% Hyperbaric Bupivacaine based on a modified Harten's Chart in non pregnant patients.
Secondary ID [1] 309740 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal anaesthesia for surgical procedures 330588 0
Condition category
Condition code
Anaesthesiology 327016 327016 0 0
Anaesthetics
Anaesthesiology 327017 327017 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After securing informed consent, each patient will be allocated to either group: Arm 1 (Controls group with fixed dose of 0.5% Hyperbaric Bupivacaine (FD Group)), and Arm2: (Cases group with modified dose of 0.5% Hyperbaric Bupivacaine (MD Group)), using the two sides of a coin, where Head is for Arm1 and Tails for Arm2.

Arm 2 (MD Group): Spinal Anesthesia with dose of 0.5% hyperbaric Bupivacaine chosen accorded to height and weight following a modified Harten’s chart table + 25 micrograms of Fentanyl.
- the dose administered will be: 0.5% Hyperbaric Bupivacaine according to Harten’s chart + 1 ml 0.5% Hyperbaric Bupivacaine + 25 micrograms Fentanyl, will be administered intrathecally immediately after placing the standard anesthesiology monitors (blood pressure cuff for blood pressure, pulse oximeter for heart rate and oxygen saturation) and before the operation room timeout for surgery.
- the duration of administration: once before starting the surgery.
- the mode of administration: intrathecally (Spinal Anesthesia).
 an experienced anesthesiologist will give spinal anaesthesia (injecting the previously mentioned mixture intrathecally) using a 25 G pencil point needle, at level of L2-L3 or L3-L4. The needle bevel must be directed upward during injection and rate of injection will be 0.2 ml per second.
- the mode of delivery: face to face.
- the number of times: once over 1 minute.
- the location: in the operation room of a tertiary hospital: Prince Mohammed bin Abdulaziz Hospital in Riyadh Saudi Arabia.
- To reduce complications : the chosen volume (dose) of intrathecal medications is within the known commonly used doses, and the patient's blood pressure, heart rate, Oxygen saturation will be monitored continuously (every five minutes) during and after spinal anesthesia.
Intervention code [1] 326178 0
Prevention
Intervention code [2] 326459 0
Treatment: Other
Comparator / control treatment
Arm 1 (FD Group): Spinal Anesthesia with a fixed dose of 2.5 ml of 0.5% hyperbaric Bupivacaine + 25 micrograms Fentanyl, will be administered intrathecally immediately after placing the standard anesthesiology monitors (blood pressure cuff for blood pressure, pulse oximeter for heart rate and oxygen saturation) and before the operation room timeout for surgery.
- the duration of administration: once before starting the surgery.
- the mode of administration: intrathecally (Spinal Anesthesia).
 an experienced anesthesiologist will give spinal anaesthesia (injecting the previously mentioned mixture intrathecally) using a 25 G pencil point needle, at level of L2-L3 or L3-L4. The needle bevel must be directed upward during injection and rate of injection will be 0.2 ml per second.
- the mode of delivery: face to face.
- the number of times: once over 1 minute.
- the location: in the operation room of a tertiary hospital: Prince Mohammed bin Abdulaziz Hospital in Riyadh Saudi Arabia.
- To reduce complications : the chosen volume (dose) of intrathecal medications is within the known commonly used doses, the patients blood pressure, heart rate, Oxygen saturation will be monitored continuously (every five minutes) during and after spinal anesthesia.
Control group
Dose comparison

Outcomes
Primary outcome [1] 334876 0
Adequate surgical anesthesia that covers the entire duration of surgery assessed by 4 aspects:

1. Patient complaining of pain during the forceps skin test which is performed before the surgical incision, or patient complaining of pain during the time of surgery, pain would indicate inadequate anesthesia.

2. Frequent Neurological examination using Gormley, et al 3 points scale for sensory block evaluation over the Lower half of the body, following the dermatological distribution, where
(0) is equal to normal sensation (1) blunted sensation; (2) no sensation.

3. Frequent Neurological examination using Bromage scale for motor examination. where (0) means: NO motor block, (1) Inability to raise extended leg, able to move knees and feet, (2) Inability to raise extended leg able to move feet. And (3): complete block for motor limb.

4. vital signs: Hypertension (measured with non invasive blood pressure cuff) and heart rate (measured by 3 leads ECG "the electrodes will be over the right and left collar bone and the last one over the apex of the heart: on the left side of the anterior or posterior chest, lower half, laterally", also pulse oximeter will be used in monitoring the heart rate).
in case of inadequate anesthesia patient will experience Hypertension and tachycardia,

Hypertension is defined as: blood pressure (systolic and diastolic) 20% higher than the base line.
Tachycardia is defined as heart rate more than 100 beat per minute.
Timepoint [1] 334876 0
end of surgery.
Secondary outcome [1] 422315 0
Time of recovery of Motor function of lower limbs assessed by Bromage score,
Timepoint [1] 422315 0
expected motor blockade duration is 2 hours.
Secondary outcome [2] 422316 0
time of recovery of sensory function assessed by Gormley et.al 3 point scale
Timepoint [2] 422316 0
expected sensory blockade duration between 4 to 6 hours.
Secondary outcome [3] 422317 0
early complications of spinal anesthesia that occur immediately after administering the intrathecal medications, they include: hypotension and bradycardia assessed by the non invasive blood pressure cuff and pulse oximeter, and nausea and vomiting assessed by asking the patient.
Timepoint [3] 422317 0
within 15 minutes of administering spinal anesthesia.
Secondary outcome [4] 423767 0
delayed complications of Spinal Anesthesia, such as Post dural puncture headache (PDPH), backache, Urinary retention, itching, Infection, will be assessed by asking the patients to inform the researcher if they experience: headache, back pain, itching, difficulty passing urine, fever and chills.
Timepoint [4] 423767 0
two weeks from end of surgery.

Eligibility
Key inclusion criteria
Patient age from 20 years of age to 55 years of age
Male and female
Surgical Procedures eligible for Spinal anesthesia.
Minimum age
20 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient Refusal
Pediatrics
History of Spine Surgery.
Morbidly Obese  
ASA IV or more
Central Nervous system disease
Patient diagnosed with a condition that may affect the Capacity and normal physiology or anatomy of the BBB or intrathecal space
hepatic dysfunction              
Patient who require > 2 trials of Spinal Anesthesia.
Patient with contraindications to spinal anesthesia.
Pregnancy
epilepsy
renal dysfunction
Failed Spinal anesthesia and the need to convert to General anesthesia
Surgeries that requires > 120 minutes
Chronic pain Syndrome.
Drug Addiction
Allergy to Local Anesthetics

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 25554 0
Saudi Arabia
State/province [1] 25554 0
makkah province

Funding & Sponsors
Funding source category [1] 313928 0
Hospital
Name [1] 313928 0
Prince Mohammed Bin Abdulaziz Hospital
Country [1] 313928 0
Saudi Arabia
Primary sponsor type
Government body
Name
Ministry of Health
Address
MP47+W98, Al Murabba, Riyadh 12628
Country
Saudi Arabia
Secondary sponsor category [1] 316151 0
None
Name [1] 316151 0
Address [1] 316151 0
Country [1] 316151 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313074 0
Institutional Review Board for ministry of health hospitals in Riyadh
Ethics committee address [1] 313074 0
MP47+W98, Al Murabba, Riyadh 12628
Ethics committee country [1] 313074 0
Saudi Arabia
Date submitted for ethics approval [1] 313074 0
29/02/2024
Approval date [1] 313074 0
Ethics approval number [1] 313074 0

Summary
Brief summary
Surgical patients who are illegible to Spinal Anesthesia and agree to participate in this study, will be enrolled into two different groups, the control group will receive spinal anesthesia with a fixed dose (FD group) of : (2.5 ml of 0.5% Hyperbaric Bupivacaine = 12.5 mg) + (25 micrograms of Fentanyl), while the cases group will receive a modifiable dose (MD group) for spinal anesthesia chosen according height and weight : (0.5% dose of hyperbaric Bupivacaine written in mls that matches the height and weight in Harten's chart) + ( 1 ml of 0.5% hyperbaric Bupivacaine “our modification") + ( 25 micrograms Fentanyl), after administering spinal anesthesia, assessment of vital signs (heart rate, Blood pressure), the sensory blockade level and duration, motor blockade adequacy and duration will take place to know which group achieved our primary and secondary outcomes.
Trial website
Trial related presentations / publications
Public notes
This is a Randomised Controlled trial that aims to find a unified reference to anesthesiologist when choosing the optimal intrathecal Hyperbaric Bupivacaine 0.5% dose to provide adequate surgical anesthesia, and to decrease the complications associated with administering intrathecal Bupivacaine 0.5%, and to facilitate recovery and hospital discharge.

Contacts
Principal investigator
Name 126902 0
Dr AlShanbari, Manal Faiez O
Address 126902 0
Prince Mohammed bin Abdulaziz Hospital, Al-Imam Ahmad Bin Hanbal St, 9259 Al Wahah, Ar Rawabi, Riyadh
Country 126902 0
Saudi Arabia
Phone 126902 0
+966542344288
Fax 126902 0
Email 126902 0
manalfaiez@hotmail.com
Contact person for public queries
Name 126903 0
Dr AlShanbari, Manal Faiez O
Address 126903 0
Prince Mohammed bin Abdulaziz Hospital, Al-Imam Ahmad Bin Hanbal St, 9259 Al Wahah, Ar Rawabi, Riyadh
Country 126903 0
Saudi Arabia
Phone 126903 0
+966542344288
Fax 126903 0
Email 126903 0
manalfaiez@hotmail.com
Contact person for scientific queries
Name 126904 0
Dr AlShanbari, Manal Faiez O
Address 126904 0
Prince Mohammed bin Abdulaziz Hospital, Al-Imam Ahmad Bin Hanbal St, 9259 Al Wahah, Ar Rawabi, Riyadh
Country 126904 0
Saudi Arabia
Phone 126904 0
+966542344288
Fax 126904 0
Email 126904 0
manalfaiez@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21481Informed consent form    385961-(Uploaded-24-01-2024-06-52-44)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.