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Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section

Primary Purpose

Post-Dural Puncture Headache, Hypotension, Spinal Shock

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Midline Approach
Paramedian Approach
Taylors approach
Sponsored by
Bahawal Victoria Hospital Bahawalpur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post-Dural Puncture Headache focused on measuring Midline approach, Spinal anesthesia, cesarean section, Taylors approach

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Exclusion Criteria: 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

Sites / Locations

  • Bahawal Victoria Hospital BahawalpurRecruiting
  • Bahawalpur Medical & Dental College BahawalpurRecruiting
  • Hameed Latif HospitalRecruiting
  • Laeeque Rafiq Hospital (LRH) MultanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group M

Group P

Group T

Arm Description

It will involve participants who are given spinal anesthesia through midline approach.

It will involve participants who are given spinal anesthesia through paramedian approach.

It will involve participants who are given spinal anesthesia through Taylors approach.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hypotension and bradycardia secondary to sympathetic blockade
Hypothermia
Respiratory failure
Spinal Shock
Urinary retention
Meningitis
Hematoma

Full Information

First Posted
November 21, 2022
Last Updated
December 7, 2022
Sponsor
Bahawal Victoria Hospital Bahawalpur
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1. Study Identification

Unique Protocol Identification Number
NCT05637645
Brief Title
Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section
Official Title
Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section: Midline, Paramedian and Taylors Approach
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahawal Victoria Hospital Bahawalpur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 • Which approach is better in terms of avoiding intraoperative and post operative complications Participants will be given anesthesia by Midline approach paramedian approach Taylors approach
Detailed Description
Introduction to study: Different techniques and modalities are used to anesthetize the patient for the smooth conduction of surgery including, general anesthesia, spinal anesthesia, different types of regional anesthesia and monitored anesthesia care.1 According to the authors' knowledge, limited local studies are available that compare midline to the paramedian approach, Taylor's approach and Transforaminal approach of spinal anesthesia in the context of occurrence of post-dural puncture headaches, backache, hematoma, paresthesia, pulse, blood pressure, respiratory rate, temperature and urine output.3 Problem statement: Post-dural puncture headache is defined as a bilateral headache that develops within 7 days after dural puncture. It characteristically worsens 15 minutes after resuming sitting position and improves or disappears within 30 minutes of resuming supine position. It can be managed with medical as well as autologous epidural blood patch. It may result in prolonged recovery and delayed mobilization as well as psychosomatic side effects. More sinister side effects like subdural hematoma and seizures are rare but may prove fatal.2 The exact mechanism of development of postdural puncture headache is unclear. The postulated pathogenesis involves cerebrospinal fluid (CSF) leak through the dural puncture site resulting in intracranial hypotension leading to traction on intracranial structures and vasodilatation of cerebral vessels resulting in headache.2 Objectives of this research: i) To find out frequency of Post-dural puncture headache (PDPH) in patients with different groups undergoing different approaches of spinal anesthesia. ii) Impact of different approaches of spinal anesthesia on complications of spinal anesthesia. Complications are related to either exaggerated physiologic responses or needle/catheter insertion and include: Post-dural-puncture headache (PDPH) Hypotension and bradycardia secondary to sympathetic blockade Hypothermia Respiratory failure resulting from a "high spinal/block" Urinary retention Spinal infection, including aseptic meningitis Spinal or epidural hematoma Nerve or spinal cord damage, possibly resulting in paralysis Pain iii) Impact of different approaches of spinal anesthesia on vitals (pulse, BP, temperature, respiratory rate, spO2 and urine output) intraoperatively and postoperatively. Limitation of the study: The study will be limited to patients undergoing cesarean section. No general population will be involved. Methodology Paper based questionnaire will be filled out by doctors on duty during pre-operative, operative and post operative period of patients. The study will be a comparative study based on CONSORT randomized control trial in which different groups based on approaches i.e. midline, paramedian, Taylor's and transforaminal approach, will be made. Sampling will involve lottery method. Data will be analyzed by IBM SPSS Statistics Digital Software version 20.0. Data analysis will be done by comparing different groups based on approaches i.e. midline, paramedian, Taylor's and transforaminal approach. Exclusion Criteria 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 Study Setting: Emergency Operation Theatre, Bahawal Victoria Hospital, Bahawlpur. 6. Ethical Consideration Points: Applied for ERC approval at DME QMC. Obtained written consent from study participants. Given autonomy to study participants. Maintained confidentiality of the data obtained. Given some beneficial effects to study participants. No harm to study participants. Non-maleficence. Justice and fair play. No conflict of interest among study authors. Study funding source mentioned if received from outside, other than study authors. Appropriate treatment availability at our institution for diseased subjects. In case of any referral, arrangements for it would be done. Study results dissemination to study participants would be done. Plagiarism check report within appreciate limits (less than 20%) is checked by given HEC licensed criteria. Contribution of each author made in conducting the study is mentioned with his/her name, proper designation and contact number/email.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache, Hypotension, Spinal Shock, Hematoma, Bradycardia, Meningitis, Respiratory Failure
Keywords
Midline approach, Spinal anesthesia, cesarean section, Taylors approach

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to three groups in parallel for the duration of the study Group M for participants are given spinal anesthesia through Midline approach Group P for participants are given spinal anesthesia through Paramedian approach Group T for participants are given spinal anesthesia through Taylors approach
Masking
ParticipantCare Provider
Masking Description
Health care workers including nurses paramedical staff and ward boys may be masked from this study
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group M
Arm Type
Active Comparator
Arm Description
It will involve participants who are given spinal anesthesia through midline approach.
Arm Title
Group P
Arm Type
Active Comparator
Arm Description
It will involve participants who are given spinal anesthesia through paramedian approach.
Arm Title
Group T
Arm Type
Active Comparator
Arm Description
It will involve participants who are given spinal anesthesia through Taylors approach.
Intervention Type
Procedure
Intervention Name(s)
Midline Approach
Other Intervention Name(s)
Spinal needle, Bupivacaine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Paramedian Approach
Other Intervention Name(s)
Spinal needle, Bupivacaine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Taylors approach
Other Intervention Name(s)
Spinal needle, Bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-dural-puncture headache (PDPH)
Description
PDPH is the most common complication after spinal anesthesia. Our study is based on prevention of PDPH using different approach in spinal anesthesia
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Hypotension and bradycardia secondary to sympathetic blockade
Time Frame
1 day
Title
Hypothermia
Time Frame
1 day
Title
Respiratory failure
Time Frame
5 days
Title
Spinal Shock
Time Frame
1 day
Title
Urinary retention
Time Frame
1 month
Title
Meningitis
Time Frame
1 month
Title
Hematoma
Time Frame
5 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Ali Fayyaz, MBBS, BSC
Phone
03360769913
Email
mafayyazbonamana1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Ali Fayyaz, MBBS, BSC
Organizational Affiliation
Bahawal Victoria Hospital Bahawalpur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahawal Victoria Hospital Bahawalpur
City
Bahawalpur
State/Province
Punjab
ZIP/Postal Code
63100
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Soufia Farrukh, FCPS, FRCS
Phone
(062) 2731042
Email
info.students@qamc.edu.pk
First Name & Middle Initial & Last Name & Degree
Fawad Mueen Arbi, MBBS
First Name & Middle Initial & Last Name & Degree
Amit Kumar, MBBS
First Name & Middle Initial & Last Name & Degree
Muhammad Ali Fayyaz, MBBS, BSC
Facility Name
Bahawalpur Medical & Dental College Bahawalpur
City
Bahawalpur
State/Province
Punjab
ZIP/Postal Code
63100
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Dr Ijaz Latif, MBBS, FCPS
Phone
+92 300 1478769
Email
admissions@bmdc.edu.pk
First Name & Middle Initial & Last Name & Degree
Muhammad Ali Fayyaz, MBBS, BSC
Facility Name
Hameed Latif Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54660
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yousaf Latif, MBBS, FCPS
Phone
042111000043
Email
info@hameedlatifhospital.com
First Name & Middle Initial & Last Name & Degree
Mueez Haider, MBBS
Facility Name
Laeeque Rafiq Hospital (LRH) Multan
City
Multan
State/Province
Punjab
ZIP/Postal Code
61000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ch. Muhammad Rafiq
Phone
(061) 6529860
Email
info@lrhospital.org
First Name & Middle Initial & Last Name & Degree
Muhammad Anees ur rehman, MBBS, BSC

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
11227314
Citation
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.
Results Reference
result
PubMed Identifier
30621376
Citation
Buddeberg 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.
Results Reference
result
PubMed Identifier
31653308
Citation
Fernandes 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.
Results Reference
result
PubMed Identifier
32736750
Citation
Bernstein 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.
Results Reference
result
PubMed Identifier
30237594
Citation
Parikh 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.
Results Reference
result

Learn more about this trial

Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section

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