Clinical trial NCT05637645: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Dural Puncture Headache
Hypotension
Spinal Shock
Hematoma
Bradycardia
Meningitis
Respiratory Failure
Keywords: Midline approach
Spinal anesthesia
cesarean section
Taylors approach
Lead sponsor: Bahawal Victoria Hospital Bahawalpur
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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

1. Midline approach
2. paramedian approach
3. 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.

Eligibility 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

Primary outcomes:
measure: Post-dural-puncture headache (PDPH)
timeFrame: 1 month
Secondary outcomes:
measure: Hypotension and bradycardia secondary to sympathetic blockade
timeFrame: 1 day
measure: Hypothermia
timeFrame: 1 day
measure: Respiratory failure
timeFrame: 5 days
measure: Spinal Shock
timeFrame: 1 day
measure: Urinary retention
timeFrame: 1 month
measure: Meningitis
timeFrame: 1 month
measure: Hematoma
timeFrame: 5 days
Other outcomes:
Locations:
city: Bahawalpur
country: Pakistan
facility: Bahawal Victoria Hospital Bahawalpur
state: Punjab
city: Bahawalpur
country: Pakistan
facility: Bahawalpur Medical & Dental College Bahawalpur
state: Punjab
city: Lahore
country: Pakistan
facility: Hameed Latif Hospital
state: Punjab
city: Multan
country: Pakistan
facility: Laeeque Rafiq Hospital (LRH) Multan
state: Punjab
Study officials:
affiliation: Bahawal Victoria Hospital Bahawalpur
name: Muhammad Ali Fayyaz, MBBS, BSC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.