Home » Trials » SLCTR/2024/014
Isobaric Bupivacaine versus Hyperbaric Bupivacaine for Spinal Anaesthesia in Caesarean sections: Prospective Randomized clinical trial
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SLCTR Registration Number
SLCTR/2024/014
Date of Registration
The date of last modification
Mar 17, 2025
Scientific Title of Trial
Isobaric Bupivacaine versus Hyperbaric Bupivacaine for Spinal Anaesthesia in Caesarean sections: Prospective Randomized clinical trial
Public Title of Trial
A randomized control trial to compare effectiveness and the safety of Isobaric (plain) Bupivacaine with Hyperbaric (heavy) Bupivacaine in patients undergoing caesarean sections.
Disease or Health Condition(s) Studied
Caesarian sections
Scientific Acronym
None
Public Acronym
None
Brief title
Comparison of effectiveness and the safety of Isobaric and Hyperbaric Bupivacaine in patients undergoing caesarean sections.
Universal Trial Number
U1111-1304-2194
Any other number(s) assigned to the trial and issuing authority
2023/EC/26 (Faculty of Medicine, University of Peradeniya)
What is the research question being addressed?
Is the use of isobaric bupivacaine in spinal anesthesia for caesarian section effective and safe compared to hyperbaric bupivacaine?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting: This will be carried out as a single centre study at main operating theatre and obstetric wards at Teaching Hospital Peradeniya.
Method of Randomization: Block randomization method will be used to divide them into Isobaric and Hyperbaric Bupivacaine groups. Accordingly, the first five subjects, who come for the sections will be given Isobaric and the next five subjects will be given the hyperbaric bupivacaine. An independent nursing officer, who is not involved in the study or subsequent patient management will be assigned to this task.
Intervention: In the operating theatre, blood pressure will be measured on the supine position. The mother will be cannulated with 18G cannula and a running drip with 500ml normal saline will be started. A lumbar puncture using a 25G pencil pointed needle will be used to give the drugs in to the intrathecal space at L3-4 or L4-5 intervertebral space when the patient is in the seated position. The dose of Isobaric and Hyperbaric bupivacaine will vary according to the height of the patient. Accordingly, 3 patient categories will be identified. Height of those 150cm or below, 151-159cm, 160cm and above will be given 1.5ml (7.5mg), 1.75ml (8.75mg) and 2ml (10mg) Isobaric Bupivacaine respectively. The same three height groups who receive Hyperbaric bupivacaine will receive 2.5ml(12.5mg), 2.75ml(13.75mg) and 3ml(15mg) respectively. The subjects who receive Isobaric will be kept flat with a pillow to head while the Hyperbaric group subjects will be positioned in a slight head up position using a pillow to the upper chest.
Inclusion criteria
Pregnant women undergoing elective caesarean section, above 18 years of age.
Exclusion criteria
• Patients with functional disabilities- American Society of Anesthesiologists (ASA) grade 3 and 4.
• Patients undergoing spinal anesthesia in different positions except sitting up position.
Primary outcome(s)
|
1.
Time taken to achieve satisfactory level of anesthesia and the level of sensory block intra-operatively. |
[ Intra-operative period ] |
|
2.
The duration of anesthesia (sensory block) - assessed by the time for the first pain post-operatively |
[ Intra-operative period ] |
|
3.
The degree of cardiovascular stability (systolic blood pressure drop less than 20mmHg, heart rate variability of 60 to 100) and the respiratory rate of 10 to 20) will be considered normal and stable) |
[ Intra-operative period ] |
Secondary outcome(s)
|
1.
Presence of non-specific complications such as shivering, abnormal sensations like “pins and needles”, itchiness, nausea & vomiting. |
[ Intraoperative and post operative period ] |
Target number/sample size
152 (76 per each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2024-05-01
Anticipated end date
2024-09-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
Status
Approved
Date of Approval
2023-10-12
Approval number
2023/EC/26
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Faculty of Medicine, Peradeniya 34 Galaha Rd, Kandy |
| Telephone: | 081-2396361 |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Dr Anura Abeysundara
Consultant Anaesthetist and Senior Lecturer
Department of Anaesthesiology and Critical Care,
Faculty of Medicine,
University of Peradeniya
0715386224
anuraabeysundara@gmail.com
Contact Person for Public Queries
Dr Ashani Ratnayake
Consultant Anaesthetist and Senior Lecturer
Department of Anaesthesiology and Critical Care,
Faculty of Medicine,
University of Peradeniya
0702317960
aashani909@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
