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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
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:
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
Study Setting:
Emergency Operation Theatre, Bahawal Victoria Hospital, Bahawlpur.
6. Ethical Consideration Points:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group M | Active Comparator | It will involve participants who are given spinal anesthesia through midline approach. |
|
| Group P | Active Comparator | It will involve participants who are given spinal anesthesia through paramedian approach. |
|
| Group T | Active Comparator | It will involve participants who are given spinal anesthesia through Taylors approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midline Approach | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension and bradycardia secondary to sympathetic blockade | 1 day | |
| Hypothermia | 1 day | |
| Respiratory failure |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Ali Fayyaz, MBBS, BSC | Contact | 03360769913 | mafayyazbonamana1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Ali Fayyaz, MBBS, BSC | Bahawal Victoria Hospital Bahawalpur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahawal Victoria Hospital Bahawalpur | Recruiting | Bahawalpur | Punjab Province | 63100 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11227314 | Result | 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. | |
| 30621376 | Result | 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. |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 6, 2022 | Dec 7, 2022 |
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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
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Health care workers including nurses paramedical staff and ward boys may be masked from this study
|
|
| Paramedian Approach | Procedure | 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 | Procedure | 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. |
|
|
| 5 days |
| Spinal Shock | 1 day |
| Urinary retention | 1 month |
| Meningitis | 1 month |
| Hematoma | 5 days |
| Bahawalpur Medical & Dental College Bahawalpur | Recruiting | Bahawalpur | Punjab Province | 63100 | Pakistan |
|
| Hameed Latif Hospital | Recruiting | Lahore | Punjab Province | 54660 | Pakistan |
|
| Laeeque Rafiq Hospital (LRH) Multan | Recruiting | Multan | Punjab Province | 61000 | Pakistan |
|
| 31653308 | Result | 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. |
| 32736750 | Result | 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. |
| 30237594 | Result | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| D007022 | Hypotension |
| D006406 | Hematoma |
| D001919 | Bradycardia |
| D008581 | Meningitis |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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