Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section
1 other identifier
interventional
200
1 country
4
Brief Summary
The goal of this clinical trial is to compare different approaches of spinal anesthesia in pregnant females who are having cesarean section. The main aim is
- 1.Midline approach
- 2.paramedian approach
- 3.Taylors approach
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2022
CompletedStudy Start
First participant enrolled
November 22, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedDecember 9, 2022
December 1, 2022
1 month
November 21, 2022
December 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-dural-puncture headache (PDPH)
PDPH is the most common complication after spinal anesthesia. Our study is based on prevention of PDPH using different approach in spinal anesthesia
1 month
Secondary Outcomes (7)
Hypotension and bradycardia secondary to sympathetic blockade
1 day
Hypothermia
1 day
Respiratory failure
5 days
Spinal Shock
1 day
Urinary retention
1 month
- +2 more secondary outcomes
Study Arms (3)
Group M
ACTIVE COMPARATORIt will involve participants who are given spinal anesthesia through midline approach.
Group P
ACTIVE COMPARATORIt will involve participants who are given spinal anesthesia through paramedian approach.
Group T
ACTIVE COMPARATORIt will involve participants who are given spinal anesthesia through Taylors approach.
Interventions
In the midline approach, the spinal approach to the intrathecal space is midline with a straight line shot. After infiltration with lidocaine, the spinal needle is introduced into the skin, angled slightly cephalic. The needle traverses the skin, followed by subcutaneous fat. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours.
The paramedian approach involves inserting the spinal needle 1 cm away from the midline in medial direction. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours.
his arm will have the procedure of spinal anesthetic performed via 'Taylor's approach' which is a paramedian approach to interspace L5 - S1. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours.
Eligibility Criteria
You may not qualify if:
- Patients who refuse to participate in study.
- More than 3 attempts of lumber puncture
- Previously having migraines of PDPH
- Hb less than 7
- INR more than 1.2
- Previous C-section more than 5
- Patients with placenta previa, accrete, percreta and increta
- NPO less than 6 hours preoperatively
- Patients from gynecological department other than C-section
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Bahawal Victoria Hospital Bahawalpur
Bahawalpur, Punjab Province, 63100, Pakistan
Bahawalpur Medical & Dental College Bahawalpur
Bahawalpur, Punjab Province, 63100, Pakistan
Hameed Latif Hospital
Lahore, Punjab Province, 54660, Pakistan
Laeeque Rafiq Hospital (LRH) Multan
Multan, Punjab Province, 61000, Pakistan
Related Publications (5)
Hempel V. [Spinal anesthesia for cesarean section]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2001 Jan;36(1):57-60. doi: 10.1055/s-2001-10239-8. German.
PMID: 11227314RESULTBuddeberg BS, Bandschapp O, Girard T. Post-dural puncture headache. Minerva Anestesiol. 2019 May;85(5):543-553. doi: 10.23736/S0375-9393.18.13331-1. Epub 2019 Jan 4.
PMID: 30621376RESULTFernandes NL, Dyer RA. Anesthesia for Urgent Cesarean Section. Clin Perinatol. 2019 Dec;46(4):785-799. doi: 10.1016/j.clp.2019.08.010. Epub 2019 Aug 14.
PMID: 31653308RESULTBernstein K, Hussey H, Hussey P, Gordo K, Landau R. Neuro-anesthesiology in pregnancy. Handb Clin Neurol. 2020;171:193-204. doi: 10.1016/B978-0-444-64239-4.00010-2.
PMID: 32736750RESULTParikh KS, Seetharamaiah S. Approach to failed spinal anaesthesia for caesarean section. Indian J Anaesth. 2018 Sep;62(9):691-697. doi: 10.4103/ija.IJA_457_18.
PMID: 30237594RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad Ali Fayyaz, MBBS, BSC
Bahawal Victoria Hospital Bahawalpur
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Health care workers including nurses paramedical staff and ward boys may be masked from this study
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Muhammad Ali Fayyaz
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 5, 2022
Study Start
November 22, 2022
Primary Completion
December 31, 2022
Study Completion
January 31, 2023
Last Updated
December 9, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share
This clinical trial is going to be publish in an international journal. To prevent the data from being available to every researcher will not make any difference.