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Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.

Primary Purpose

Post-Dural Puncture Headache

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Neostigmine Methylsulfate
Dextrose 5%/Nacl 0.9% Inj
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-Dural Puncture Headache focused on measuring Neostigmine, Intrathecal, prevention of PDPH, PDPH, Caesarean section

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American society association (ASA) physical status class II parturients with a single fetus who will be scheduled for an elective caesarian section by Intrathecal block.

Exclusion Criteria:

  • Body mass index more than or equal to 35 kg/m2.
  • 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.

Sites / Locations

  • Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The Intervention group (N)

The control group (C)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of post-dural puncture headache
any headache that develops within five days of dural puncture and can't be attributed to any other types of headache and mostly is postural in character.usually associated with neck stiffness, nausea, photophobia, and subjective hearing symptoms

Secondary Outcome Measures

Full Information

First Posted
March 13, 2022
Last Updated
July 25, 2023
Sponsor
Alexandria University
Collaborators
Kasr El Aini Hospital, Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT05289323
Brief Title
Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.
Official Title
Evaluation of Intrathecal Neostigmine as an Adjuvant to Bupivacaine in Ameliorating Post-Dural Puncture Headache in Elective Caesarian Section: A Prospective Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
Collaborators
Kasr El Aini Hospital, Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Intravenous neostigmine was recently reported as an effective treatment for PDPH for parturients after intrathecal (IT) block which is postulated to be through its central effects on CSF secretion and cerebral vascular tone modulation. Intrathecal neostigmine has been investigated widely and found to be an effective adjuvant to bupivacaine for postoperative analgesia. 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.
Detailed Description
Upon arrival to the operating room standard monitors will be applied and continued all over the operation, an 18G peripheral intravenous (IV) cannula will be inserted, and 15 ml/kg of Ringer lactate solution will be infused. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache
Keywords
Neostigmine, Intrathecal, prevention of PDPH, PDPH, Caesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
722 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Intervention group (N)
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group (C)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Neostigmine Methylsulfate
Other Intervention Name(s)
Neostigmine 20 mic
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dextrose 5%/Nacl 0.9% Inj
Other Intervention Name(s)
Dextrose 5 %Nacl0.9%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of post-dural puncture headache
Description
any headache that develops within five days of dural puncture and can't be attributed to any other types of headache and mostly is postural in character.usually associated with neck stiffness, nausea, photophobia, and subjective hearing symptoms
Time Frame
Two times daily for five days after intrathecal block.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American society association (ASA) physical status class II parturients with a single fetus who will be scheduled for an elective caesarian section by Intrathecal block. Exclusion Criteria: Body mass index more than or equal to 35 kg/m2. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham M Gamal Eldine, MD
Organizational Affiliation
University of Alexandria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed I Elnaggar, MD
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14570796
Citation
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.
Results Reference
result
PubMed Identifier
23846960
Citation
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.
Results Reference
result
PubMed Identifier
1865208
Citation
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.
Results Reference
result
PubMed Identifier
30169405
Citation
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.
Results Reference
result
PubMed Identifier
31791560
Citation
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. Erratum In: Best Pract Res Clin Anaesthesiol. 2021 Dec;35(4):E3-E4.
Results Reference
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PubMed Identifier
9801540
Citation
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.
Results Reference
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PubMed Identifier
29368949
Citation
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.
Results Reference
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PubMed Identifier
2400077
Citation
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.
Results Reference
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PubMed Identifier
19897823
Citation
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.
Results Reference
result

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Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.

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