Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.

NCT05289323 | Completed Phase 4

• 1 other identifier: IRB NO: 00012098 SN: 0305408
• Study Type: interventional
• Target: 722
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Dural Puncture Headache

Keywords

Neostigmine; Intrathecal; prevention of PDPH; PDPH; Caesarean section

Outcome Measures

Primary Outcomes (1)

• 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

  Two times daily for five days after intrathecal block.

Study Arms (2)

The Intervention group (N)

EXPERIMENTAL

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.

Drug: Neostigmine Methylsulfate

The control group (C)

PLACEBO COMPARATOR

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.

Drug: Dextrose 5%/Nacl 0.9% Inj

Interventions

Neostigmine Methylsulfate DRUG

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.

Also known as: Neostigmine 20 mic

The Intervention group (N)

Dextrose 5%/Nacl 0.9% Inj DRUG

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.

Also known as: Dextrose 5 %Nacl0.9%

The control group (C)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead
• Kasr El Aini Hospital: collaborator
• Fayoum University: collaborator

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Related Publications (9)

• 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.

  PMID: 14570796 RESULT

• 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.

  PMID: 23846960 RESULT

• 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.

  PMID: 1865208 RESULT

• 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.

  PMID: 30169405 RESULT

• 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.

  PMID: 31791560 RESULT

• 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.

  PMID: 9801540 RESULT

• 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.

  PMID: 29368949 RESULT

• 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.

  PMID: 2400077 RESULT

• 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.

  PMID: 19897823 RESULT

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Neostigmine; Glucose; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hisham M Gamal Eldine, MD

  University of Alexandria

  STUDY DIRECTOR

• Ahmed I Elnaggar, MD

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: March 21, 2022
• Study Start: April 25, 2022
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)