Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.
NCT ID: NCT05289323
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
722 participants
INTERVENTIONAL
2022-04-25
2023-07-25
Brief Summary
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The objective of the current study is to investigate the possible prophylactic role of intrathecal neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture headache in parturients scheduled for an elective cesarean section.
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Detailed Description
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The intrathecal block will be performed via a midline approach into the L3-4 or L4-5 interspaces in a sitting position under strict aseptic condition using a 25-gauge spinal needle after administration of 3 ml of lidocaine 2% (60 mg) as a subcutaneous infiltration, a 2.5 ml of hyperbaric bupivacaine, 0.5 % (12.5 mg) in addition to the content of the prepared study syringe will be mixed and slowly injected.
After ensuring sufficient anesthesia level by loss of sensation to pinprick at the T4 level, the surgical procedure will start with continuous hemodynamic monitoring and recording.
At the end of the surgery, the parturient will be transferred to the postoperative anesthesia care unit (PACU).
Parturients will be transferred to the obstetrics ward after fulfilling the criteria of the modified Aldrete scoring system ≥9.
The participants who will be diagnosed to have PDPH Per the previously mentioned criteria will be treated by using oral Panadol extra™ (paracetamol 1gm + caffeine 135 mg) (Manufactured by: Alexandria company for pharmaceuticals \& chemical industries under license: GlaxoSmithKline Consumer Healthcare Ltd. Ireland) at 6-hour interval in addition to ensuring good oral or intravenous hydration (2-3 L/day) and bed rest. Severe Intractable headache (VAS ≥ 4) persistent for more than 48 hours with no response to conservative measures will be managed with an autologous epidural blood patch after participant approval and consent signing.
Assessment of the quality of the sensory and motor block in terms of the onset and duration will be done at 2 minutes intervals during the first 10 minutes after giving the spinal block, then at 10 minutes intervals until the end of the surgery, and at 15 minutes intervals while being in the PACU.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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The Intervention group (N)
0.5 mg ampule (1 ml) will be diluted in 4 ml dextrose 5% to make a solution of 100 μg/ml, 0.2 ml of this solution will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % used for intrathecal injection.
Neostigmine Methylsulfate
0.5 mg ampule (1 ml) will be diluted in 4 ml dextrose 5% to make a solution of 100 μg/ml, 0.2 ml of this solution will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % used for intrathecal injection.
The control group (C)
one ml of normal saline 0.9 % will be mixed with 4 ml dextrose 5 % in the five-milliliter syringe. 0.2 ml of this mixture will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % used for intrathecal injection.
Dextrose 5%/Nacl 0.9% Inj
one ml of normal saline 0.9 % will be mixed with 4 ml dextrose 5 % in the five-milliliter syringe. 0.2 ml of this mixture will be prepared at a one-milliliter identical syringe.
Interventions
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Neostigmine Methylsulfate
0.5 mg ampule (1 ml) will be diluted in 4 ml dextrose 5% to make a solution of 100 μg/ml, 0.2 ml of this solution will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % used for intrathecal injection.
Dextrose 5%/Nacl 0.9% Inj
one ml of normal saline 0.9 % will be mixed with 4 ml dextrose 5 % in the five-milliliter syringe. 0.2 ml of this mixture will be prepared at a one-milliliter identical syringe.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any contraindication to Intrathecal blocks such as local infection, bleeding disorders, or parturient refusal.
* Allergy to neostigmine or other drugs will be used in the study.
* Long-term opioid use.
* A history of chronic pain, migraine, cluster headache.
* Digestive problems with nausea and vomiting; cognitive dysfunction or memory disorders.
* Significant renal, hepatic, and cardiovascular diseases.
* History of urinary retention or bronchial asthma.
* Inadequate or failed Intrathecal block.
* Complicated pregnancy such as hypertensive disorders of the pregnancy, abnormal placenta, or uterine atony.
20 Years
40 Years
FEMALE
No
Sponsors
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Kasr El Aini Hospital
OTHER
Fayoum University
OTHER
Alexandria University
OTHER
Responsible Party
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Ahmed Ismail Elnaggar
Principal Investigator
Principal Investigators
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Hisham M Gamal Eldine, MD
Role: STUDY_DIRECTOR
University of Alexandria
Ahmed I Elnaggar, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alexandria
Locations
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Alexandria University
Alexandria, , Egypt
Countries
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References
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Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. doi: 10.1093/bja/aeg231.
Arevalo-Rodriguez I, Ciapponi A, Munoz L, Roque i Figuls M, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013 Jul 12;(7):CD009199. doi: 10.1002/14651858.CD009199.pub2.
Grant R, Condon B, Hart I, Teasdale GM. Changes in intracranial CSF volume after lumbar puncture and their relationship to post-LP headache. J Neurol Neurosurg Psychiatry. 1991 May;54(5):440-2. doi: 10.1136/jnnp.54.5.440.
Abdelaal Ahmed Mahmoud A, Mansour AZ, Yassin HM, Hussein HA, Kamal AM, Elayashy M, Elemady MF, Elkady HW, Mahmoud HE, Cusack B, Hosny H, Abdelhaq M. Addition of Neostigmine and Atropine to Conventional Management of Postdural Puncture Headache: A Randomized Controlled Trial. Anesth Analg. 2018 Dec;127(6):1434-1439. doi: 10.1213/ANE.0000000000003734.
Prabhakar A, Lambert T, Kaye RJ, Gaignard SM, Ragusa J, Wheat S, Moll V, Cornett EM, Urman RD, Kaye AD. Adjuvants in clinical regional anesthesia practice: A comprehensive review. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):415-423. doi: 10.1016/j.bpa.2019.06.001. Epub 2019 Jul 2.
Aldrete JA. Modifications to the postanesthesia score for use in ambulatory surgery. J Perianesth Nurs. 1998 Jun;13(3):148-55. doi: 10.1016/s1089-9472(98)80044-0.
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
Cesarini M, Torrielli R, Lahaye F, Mene JM, Cabiro C. Sprotte needle for intrathecal anaesthesia for caesarean section: incidence of postdural puncture headache. Anaesthesia. 1990 Aug;45(8):656-8. doi: 10.1111/j.1365-2044.1990.tb14392.x.
Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
Other Identifiers
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IRB NO: 00012098 SN: 0305408
Identifier Type: -
Identifier Source: org_study_id
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