Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section
NCT ID: NCT05637645
Last Updated: 2022-12-09
Study Results
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Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2022-11-22
2023-01-31
Brief Summary
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• 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Group M
It will involve participants who are given spinal anesthesia through midline approach.
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.
Group P
It will involve participants who are given spinal anesthesia through paramedian approach.
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.
Group T
It will involve participants who are given spinal anesthesia through Taylors approach.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Exclusion Criteria
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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Bahawal Victoria Hospital Bahawalpur
OTHER
Responsible Party
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Muhammad Ali Fayyaz
Dr Muhammad Ali Fayyaz
Principal Investigators
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Muhammad Ali Fayyaz, MBBS, BSC
Role: PRINCIPAL_INVESTIGATOR
Bahawal Victoria Hospital Bahawalpur
Locations
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Bahawal Victoria Hospital Bahawalpur
Bahawalpur, Punjab Province, Pakistan
Bahawalpur Medical & Dental College Bahawalpur
Bahawalpur, Punjab Province, Pakistan
Hameed Latif Hospital
Lahore, Punjab Province, Pakistan
Laeeque Rafiq Hospital (LRH) Multan
Multan, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Prof. Dr. Soufia Farrukh, FCPS, FRCS
Role: primary
Prof Dr Ijaz Latif, MBBS, FCPS
Role: primary
Yousaf Latif, MBBS, FCPS
Role: primary
Ch. Muhammad Rafiq
Role: primary
References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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1229/DME/QAMC Bahawalpur
Identifier Type: -
Identifier Source: org_study_id