Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section

Bahawal Victoria Hospital Bahawalpur

Status: Enrolling

Conditions: Bradycardia; Hypotension; Meningitis; Respiratory Failure; Post-Dural Puncture Headache; Spinal Shock; Hematoma

Treatments: Procedure: Midline Approach; Procedure: Taylors approach; Procedure: Paramedian Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT05637645

1229/DME/QAMC Bahawalpur

Details and patient eligibility

About

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

Full 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:

7. Applied for ERC approval at DME QMC.

8. Obtained written consent from study participants.

9. Given autonomy to study participants.

10. Maintained confidentiality of the data obtained.

11. Given some beneficial effects to study participants.

12. No harm to study participants.

13. Non-maleficence.

14. Justice and fair play.

15. No conflict of interest among study authors.

16. Study funding source mentioned if received from outside, other than study authors.

17. Appropriate treatment availability at our institution for diseased subjects.

18. In case of any referral, arrangements for it would be done.

19. Study results dissemination to study participants would be done.

20. Plagiarism check report within appreciate limits (less than 20%) is checked by given HEC licensed criteria.

21. Contribution of each author made in conducting the study is mentioned with his/her name, proper designation and contact number/email.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 3 patient groups

Group M

Active Comparator group

Description:

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

Treatment:

Procedure: Midline Approach

Group P

Active Comparator group

Description:

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

Treatment:

Procedure: Paramedian Approach

Group T

Active Comparator group

Description:

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

Treatment:

Procedure: Taylors approach