Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001209583
Ethics application status
Approved
Date submitted
31/07/2024
Date registered
2/10/2024
Date last updated
2/10/2024
Date data sharing statement initially provided
2/10/2024
Date results provided
2/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative Study of Hyperbaric Bupivacaine plus Ketamine vs. Bupivacaine plus Fentanyl for Spinal Anesthesia during Cesarean Section.
Scientific title
Comparative Study of Hyperbaric Bupivacaine plus Ketamine vs. Bupivacaine plus Fentanyl for Spinal Anesthesia during Cesarean Section. A prospective , Randomized , Double -Blind, controlled study in pregnant women with age (18-45) years old.
Secondary ID [1] 312653 0
Nil known'
Secondary ID [2] 312776 0
Nil known'
Universal Trial Number (UTN)
U1111-1311-3334
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain after cesarean section surgery 334619 0
Condition category
Condition code
Anaesthesiology 331204 331204 0 0
Pain management
Reproductive Health and Childbirth 331389 331389 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Interventional group was administered Preservative-free ketamine 15 mg
plus bupivacaine 10 mg (Marcaine) 0.5%, and in the B group was administered bupivacaine
10 mg (Marcaine) 0.5% alone. The strategies we’re used to evaluate the patient through self monitoring and closed observation.
An anesthesiologist performed the spinal puncture by pencil-point spinal needle (27 Fr) between the L3 to L4 or L4–L5 vertebrae with the patient in a sitting position on the side of the operation table.
Intervention code [1] 329182 0
Treatment: Drugs
Comparator / control treatment

A control group was received a solution containing bupivacaine 10mg (Marcaine) 0.5 % plus 25 mcg fentanyl was administered.
Control group
Active

Outcomes
Primary outcome [1] 338989 0
Assessing dermatome levels
Timepoint [1] 338989 0
After administering a subarachnoid block every minute after the puncture, until ensure sensory block is done.
Primary outcome [2] 338990 0
The grade of sedation.
Timepoint [2] 338990 0
after administering a subarachnoid block until the end of surgery from 30 to 45 minutes.
Secondary outcome [1] 438192 0
motor blockade
Timepoint [1] 438192 0
every minute during the intraoperative and postoperative until the patient is able to move her lower extremity
Secondary outcome [2] 438193 0
pain intensity.
Timepoint [2] 438193 0
in post operative period to Time for first utilization for analgesic is registered.

Eligibility
Key inclusion criteria
A pregnant women with age (18-45) years old and planned for elective cesarean sections delivery with ASA Classification I &II, at specialized Arab hospital.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women with spinal block contraindications and those with a history of ketamine medication allergies.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence was generated on a computer using random allotment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data were analyzed using the SPSS version22. Following a normality inspection, the data was found to be normally distributed. The baseline characteristics of the study subjects were presented using descriptive statistics including mean±SD, median, and frequency with the percentage. Chi Square test was utilized to examine differences between Percentages, Turkey HSD Post-Hoc test examined pairwise differences between mean p < 0.05 is considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/06/2020
Date of last participant enrolment
Anticipated
Actual
17/09/2020
Date of last data collection
Anticipated
Actual
17/09/2020
Sample size
Target
105
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 26487 0
Palestinian Territory, Occupied
State/province [1] 26487 0
Nablus

Funding & Sponsors
Funding source category [1] 317087 0
Self funded/Unfunded
Name [1] 317087 0
Country [1] 317087 0
Primary sponsor type
Individual
Name
Mohammed Joori
Address
Country
Palestinian Territory, Occupied
Secondary sponsor category [1] 319353 0
None
Name [1] 319353 0
Address [1] 319353 0
Country [1] 319353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315837 0
IRB committee Chairman of An- Najah National University's.
Ethics committee address [1] 315837 0
Ethics committee country [1] 315837 0
Palestinian Territory, Occupied
Date submitted for ethics approval [1] 315837 0
20/05/2020
Approval date [1] 315837 0
28/05/2020
Ethics approval number [1] 315837 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135954 0
Mr Mohammed Joori
Address 135954 0
Andaleeb Al-Amad College for Nursing and Midwifery, Nablus- Palestine. 972,Northern mountain
Country 135954 0
Palestinian Territory, Occupied
Phone 135954 0
+972597862528
Fax 135954 0
Email 135954 0
[email protected]
Contact person for public queries
Name 135955 0
Mohammed Joori
Address 135955 0
Andaleeb Al-Amad College for Nursing and Midwifery, Nablus- Palestine. 972,Northern mountain
Country 135955 0
Palestinian Territory, Occupied
Phone 135955 0
+972597862528
Fax 135955 0
Email 135955 0
[email protected]
Contact person for scientific queries
Name 135956 0
Mohammed Joori
Address 135956 0
Andaleeb Al-Amad College for Nursing and Midwifery, Nablus- Palestine. 972,Northern mountain
Country 135956 0
Palestinian Territory, Occupied
Phone 135956 0
+972597862528
Fax 135956 0
Email 135956 0
[email protected]

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?

No Supporting Document Provided



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.