Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial

July 14, 2024 updated by: Mina Maher, Minia University
Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 4

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Parturient ladies
  • Age ranges from 18 to 35 years old.
  • ASA II with elective caesarean section under sub-arachnoid block

Exclusion Criteria:

  • BMI >35
  • Refusal to participate
  • surgical complications necessitating a blood transfusion
  • Emergency caesarean section
  • the need for endotracheal intubation or vasopressors
  • any contraindication to regional anesthesia (such as a history of persistent cephalgia, convulsions, cerebrovascular events

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
intravenous 50 mL of sterile saline 0.9% injection of 0.9% after umbilical cord clamping.
Drug: intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.
intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.
Active Comparator: Neostgmine group
Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.
Drug: Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.
Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of patients with post dural puncture headache
Time Frame: first 5 days post-partum
Number of patients develop post dural puncture headache
first 5 days post-partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of post dural puncture headache
Time Frame: first 5 days post-partum
Visual analogue scale score for pain assessment. from 0 to ten. 0= no pain 1-3= mild pain....4-6= moderate pain ... 7-10= severe pain
first 5 days post-partum
onset and duration of post dural puncture headache
Time Frame: 5 days post partum
Time when visual analogue scale score increase and duration until return to 0. Visual analogue scale score for pain assessment. from 0 to ten. 0= no pain 1-3= mild pain....4-6= moderate pain ... 7-10= severe pain
5 days post partum
Analgesic request
Time Frame: 24 hours after operation
First time to analgesic request from block
24 hours after operation
Analgesc requirements
Time Frame: 2 days after operation
Total analgesic requirements
2 days after operation
frequency of analgesic doses
Time Frame: 5 days
number of analgesic doses given to the patient
5 days
incidence of complications related to the procedure
Time Frame: 6 hours after procedure
number of patients with adverse events as bradycardia, tachcardia, miosis,muscle cramps, twitches, colics, hypotension
6 hours after procedure

Collaborators and Investigators

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

Sponsor

Minia University

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 (Estimated)

July 15, 2024

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

January 16, 2025

Study Registration Dates

First Submitted

June 30, 2024

First Submitted That Met QC Criteria

June 30, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 14, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0379/2023

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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