Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.

July 25, 2023 updated by: Ahmed Ismail Elnaggar, Alexandria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

722

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Neostigmine 20 mic
Placebo Comparator: 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.
Drug: 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 Names:
  • Dextrose 5 %Nacl0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-dural puncture headache
Time Frame: Two times daily for five days after intrathecal block.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Collaborators

Kasr El Aini Hospital
Fayoum University

Investigators

  • Study Director: Hisham M Gamal Eldine, MD, University of Alexandria
  • Principal Investigator: Ahmed I Elnaggar, MD, University of Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2022

Primary Completion (Actual)

July 25, 2023

Study Completion (Actual)

July 25, 2023

Study Registration Dates

First Submitted

March 13, 2022

First Submitted That Met QC Criteria

March 13, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB NO: 00012098 SN: 0305408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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