Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section

Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section: Midline, Paramedian and Taylors Approach

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

1. Midline approach
2. paramedian approach
3. Taylors approach

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Bradycardia; Hypotension; Meningitis; Hematoma; Post-Dural Puncture Headache; Spinal Shock
• Intervention / Treatment: Procedure: Midline Approach; Procedure: Paramedian Approach; Procedure: Taylors approach

Detailed Description

1. 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

2. 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

3. 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.

4. Limitation of the study:

   The study will be limited to patients undergoing cesarean section. No general population will be involved.

5. 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

1. Patients who refuse to participate in study.
2. More than 3 attempts of lumber puncture
3. Previously having migraines of PDPH
4. Hb less than 7
5. INR more than 1.2
6. Previous C-section more than 5
7. Patients with placenta previa, accrete, percreta and increta
8. NPO less than 6 hours preoperatively
9. Patients from gynecological department other than C-section

Study Setting:

Emergency Operation Theatre, Bahawal Victoria Hospital, Bahawlpur.

6. Ethical Consideration Points:

1. Applied for ERC approval at DME QMC.
2. Obtained written consent from study participants.
3. Given autonomy to study participants.
4. Maintained confidentiality of the data obtained.
5. Given some beneficial effects to study participants.
6. No harm to study participants.
7. Non-maleficence.
8. Justice and fair play.
9. No conflict of interest among study authors.
10. Study funding source mentioned if received from outside, other than study authors.
11. Appropriate treatment availability at our institution for diseased subjects.
12. In case of any referral, arrangements for it would be done.
13. Study results dissemination to study participants would be done.
14. Plagiarism check report within appreciate limits (less than 20%) is checked by given HEC licensed criteria.
15. Contribution of each author made in conducting the study is mentioned with his/her name, proper designation and contact number/email.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Ali Fayyaz, MBBS, BSC; Phone Number: 03360769913; Email: mafayyazbonamana1@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Bahawalpur, Punjab, Pakistan, 63100
      • Recruiting
      • Bahawal Victoria Hospital Bahawalpur
      • Contact: Prof. Dr. Soufia Farrukh, FCPS, FRCS; Phone Number: (062) 2731042; Email: info.students@qamc.edu.pk
      • Sub-Investigator: Fawad Mueen Arbi, MBBS
      • Sub-Investigator: Amit Kumar, MBBS
      • Principal Investigator: Muhammad Ali Fayyaz, MBBS, BSC
    • Bahawalpur, Punjab, Pakistan, 63100
      • Recruiting
      • Bahawalpur Medical & Dental College Bahawalpur
      • Principal Investigator: Muhammad Ali Fayyaz, MBBS, BSC
      • Contact: Prof Dr Ijaz Latif, MBBS, FCPS; Phone Number: +92 300 1478769; Email: admissions@bmdc.edu.pk
    • Lahore, Punjab, Pakistan, 54660
      • Recruiting
      • Hameed Latif Hospital
      • Contact: Yousaf Latif, MBBS, FCPS; Phone Number: 042111000043; Email: info@hameedlatifhospital.com
      • Sub-Investigator: Mueez Haider, MBBS
    • Multan, Punjab, Pakistan, 61000
      • Recruiting
      • Laeeque Rafiq Hospital (LRH) Multan
      • Contact: Ch. Muhammad Rafiq; Phone Number: (061) 6529860; Email: info@lrhospital.org
      • Sub-Investigator: Muhammad Anees ur rehman, MBBS, BSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Exclusion Criteria:

1. Patients who refuse to participate in study.
2. More than 3 attempts of lumber puncture
3. Previously having migraines of PDPH
4. Hb less than 7
5. INR more than 1.2
6. Previous C-section more than 5
7. Patients with placenta previa, accrete, percreta and increta
8. NPO less than 6 hours preoperatively
9. Patients from gynecological department other than C-section

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group M; It will involve participants who are given spinal anesthesia through midline approach.	Procedure: Midline Approach; 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.; Other Names: Bupivacaine; Spinal needle
Active Comparator: Group P; It will involve participants who are given spinal anesthesia through paramedian approach.	Procedure: Paramedian Approach; 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.; Other Names: Bupivacaine; Spinal needle
Active Comparator: Group T; It will involve participants who are given spinal anesthesia through Taylors approach.	Procedure: Taylors approach; 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.; Other Names: Bupivacaine; Spinal needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Hypotension and bradycardia secondary to sympathetic blockade	1 day
Hypothermia	1 day
Respiratory failure	5 days
Spinal Shock	1 day
Urinary retention	1 month
Meningitis	1 month
Hematoma	5 days

Collaborators and Investigators

• Sponsor: Bahawal Victoria Hospital Bahawalpur
• Investigators: Principal Investigator: Muhammad Ali Fayyaz, MBBS, BSC, Bahawal Victoria Hospital Bahawalpur

Publications and helpful links

General Publications

• Hempel V. [Spinal anesthesia for cesarean section]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2001 Jan;36(1):57-60. Review. German.
• 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. Review.
• 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. Review.
• 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. Review.
• 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. Review.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: cesarean section; Spinal anesthesia; Midline approach; Taylors approach
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Pain; Neurologic Manifestations; Hemorrhage; Arrhythmias, Cardiac; Headache Disorders; Headache Disorders, Secondary; Respiratory Insufficiency; Bradycardia; Headache; Hypotension; Meningitis; Hematoma; Post-Dural Puncture Headache; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 1229/DME/QAMC Bahawalpur

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No