Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia (OPDPH)

June 5, 2024 updated by: Mhamed Sami Mebazaa, Mongi Slim Hospital

Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections : A Randomized Controlled Trial

A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups:

Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia

OBJECTIVE :

To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Spinal anesthesia is the most common anesthetic technique used for Caesarean sections. However, it is not denied from complications.

Post-dural puncture headache is a major complication of spinal anesthesia, with an incidence ranging from 1.5% to 36%.

OBJECTIVE :

To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.

the investigators conducted a prospective, bicentric, randomized, double-blind controlled study over a period of 07 months from November 2023 to june 2024.

the investigators included in the study all parturients:

  • Aged between 18-45 years
  • ASA 2
  • Between 37 and 41 weeks of gestation
  • scheduled for elective caesarean delivery under spinal anaesthesia
  • To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification.

The eligible parturients were randomly assigned to two groups through block randomization using computerized random numbers.

were assigned to one of the two parallel groups to receive either :

  • Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia : Group O (Ondansetron)
  • Or IV normal saline 5 ml (control group) 5 min before spinal anesthesia : Group C (control)

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Amani Ben haj Youssef, assistant
  • Phone Number: 00216 96874336
  • Email: amanibhy@hotmail.fr

Study Locations

  • Tunisia
      • Tunis, Tunisia, 2085
        • Recruiting
        • Mongi Slim Hospital
        • Contact:
        • Contact:

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:

  • Aged between 18-45 years
  • ASA 2
  • Between 37 and 41 weeks of gestation
  • scheduled for elective caesarean delivery under spinal anaesthesia
  • To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification

Exclusion Criteria:

  • All patients who required :
  • more than two attempts for spinal anaesthesia
  • conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level <T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock).

As well as patients who have subsequently withdrawn their consent for participating to our study.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group O
Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Drug: Intravenous ondansetron
Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Other Names:
  • ondansetron
Placebo Comparator: Group C
Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
Drug: Intravenous normal saline
Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.
Time Frame: 7 days
the occurrence of positional headaches at any time postoperatively
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
day of PDPH's occurence
Time Frame: 7 days
on postoperatively
7 days
day of PDPH's resolution
Time Frame: 7 days
on postoperatively
7 days
Headache severity
Time Frame: 7 days
assessed by the numerical pain scale from 0 to 10 (0 being no pain and 10 being the maximum unimaginable pain).
7 days
Need for analgesic treatment due to headaches
Time Frame: 7 days
paracetamol or NSAIDs
7 days
Occurrence of post-operative nausea and/or vomiting
Time Frame: 7 days
need of treatement
7 days
Mean arterial pressure in mmgh
Time Frame: 3 days
Mean arterial pressure during hospitalization
3 days
heart rate
Time Frame: 3 days
Mean arterial pressure during hospitalization
3 days

Collaborators and Investigators

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

Sponsor

Mongi Slim Hospital

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)

November 30, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ondansetron effect on PDPH

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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