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Post-Dural Puncture HeadacheNCT05637645

Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section

A study testing Midline Approach, Paramedian Approach and Taylors approach in people with Post-Dural Puncture Headache and Hypotension, run by Bahawal Victoria Hospital Bahawalpur at 4 sites in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
What is being tested?
Midline Approach, Paramedian Approach and Taylors approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesPakistan
Study dates
22 Nov 2022to 31 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Muhammad Ali Fayyaz, MBBS, BSC contact

03360769913

mafayyazbonamana1@gmail.com

Pakistan4 sites, 4 recruiting
  • Bahawal Victoria Hospital Bahawalpur

    Bahawalpur, Punjab Province, 63100

    Prof. Dr. Soufia Farrukh, FCPS, FRCS, (062) 2731042, info.students@qamc.edu.pk

    Fawad Mueen Arbi, MBBS

    Recruiting
  • Bahawalpur Medical & Dental College Bahawalpur

    Bahawalpur, Punjab Province, 63100

    Prof Dr Ijaz Latif, MBBS, FCPS, +92 300 1478769, admissions@bmdc.edu.pk

    Muhammad Ali Fayyaz, MBBS, BSC

    Recruiting
  • Hameed Latif Hospital

    Lahore, Punjab Province, 54660

    Yousaf Latif, MBBS, FCPS, 042111000043, info@hameedlatifhospital.com

    Mueez Haider, MBBS

    Recruiting
  • Laeeque Rafiq Hospital (LRH) Multan

    Multan, Punjab Province, 61000

    Ch. Muhammad Rafiq, (061) 6529860, info@lrhospital.org

    Muhammad Anees ur rehman, MBBS, BSC

    Recruiting

Other trials in Pakistan

About this study

Official title: 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
Read the 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:
  4. 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.
  1. Limitation of the study: The study will be limited to patients undergoing cesarean section. No general population will be involved.
  2. 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.

  1. Ethical Consideration Points:
  2. Applied for ERC approval at DME QMC.
  3. Obtained written consent from study participants.
  4. Given autonomy to study participants.
  5. Maintained confidentiality of the data obtained.
  6. Given some beneficial effects to study participants.
  7. No harm to study participants.
  8. Non-maleficence.
  9. Justice and fair play.
  10. No conflict of interest among study authors.
  11. Study funding source mentioned if received from outside, other than study authors.
  12. Appropriate treatment availability at our institution for diseased subjects.
  13. In case of any referral, arrangements for it would be done.
  14. Study results dissemination to study participants would be done.
  15. Plagiarism check report within appreciate limits (less than 20%) is checked by given HEC licensed criteria.
  16. Contribution of each author made in conducting the study is mentioned with his/her name, proper designation and contact number/email.
Being tested
Midline Approach, Paramedian Approach, Taylors approach
Keywords
Midline approach, Spinal anesthesia, cesarean section, Taylors approach
Medical subject headings
Post-Dural Puncture Headache, Hypotension, Hematoma, Bradycardia, Meningitis, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Midline ApproachProcedure or surgery

    Also called Spinal needle, Bupivacaine

    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 ApproachProcedure or surgery

    Also called Spinal needle, Bupivacaine

    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 approachProcedure or surgery

    Also called Spinal needle, Bupivacaine

    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.

Study groups in NCT05637645
Study groupRoleWhat they receive
Group MActive comparatorIt will involve participants who are given spinal anesthesia through midline approach.
Receives: Procedure: Midline Approach
Group PActive comparatorIt will involve participants who are given spinal anesthesia through paramedian approach.
Receives: Procedure: Paramedian Approach
Group TActive comparatorIt will involve participants who are given spinal anesthesia through Taylors approach.
Receives: Procedure: Taylors approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month

Secondary outcomes (7)
  1. Hypotension and bradycardia secondary to sympathetic blockade

    Measured: 1 day

  2. Hypothermia

    Measured: 1 day

  3. Respiratory failure

    Measured: 5 days

  4. Spinal Shock

    Measured: 1 day

  5. Urinary retention

    Measured: 1 month

  6. Meningitis

    Measured: 1 month

  7. Hematoma

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start22 Nov 2022
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05637645
Sponsor's protocol ID
1229/DME/QAMC Bahawalpur
Status last verified
Dec 2022
First submitted
21 Nov 2022
Last updated
9 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 11227314
  • 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.

    PubMed 30621376
  • 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.

    PubMed 31653308
  • 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.

    PubMed 32736750
  • 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.

    PubMed 30237594

Questions about this trial

What is this clinical trial studying?

A study testing Midline Approach, Paramedian Approach and Taylors approach in people with Post-Dural Puncture Headache and Hypotension, run by Bahawal Victoria Hospital Bahawalpur at 4 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Muhammad Ali Fayyaz, MBBS, BSC (03360769913, mafayyazbonamana1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-dural-puncture headache (PDPH) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05637645, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.

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