The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block

March 18, 2024 updated by: Reham Mahrous, Cairo University

The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block: Comparative Randomized Controlled Study

The aim of this study is to compare the dural puncture epidural technique (DPET) with either 25-gauge spinal needle or 27-gauge spinal needle versus conventional epidural technique and evaluate whether DPET improves onset and spread of labor analgesia and if there is a role of the usage of different sized needles as regards block efficiency and complications.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

  • 81 patients primigravida parturients (ASA II) in active labor
  • uncomplicated pregnancy
  • Cephalic presentation
  • Cervical dilatation <5 cm

Exclusion criteria:

  • Allergy to local anesthetics.
  • Bleeding disorders
  • Low platelet count
  • Local or systemic sepsis
  • Prior surgery in lumbosacral spine
  • Patient's refusal.

Eighty-one patients meeting the inclusion criteria were randomly divided into three equal groups:

Group CE (n=27): Conventional epidural. Group DPE-25 (n=27): Dural puncture epidural with 25-gauge spinal needle. Group DPE-27 (n=27): Dural puncture epidural with 27-gauge spinal needle.

Randomization was done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series were unknown to the investigators and the group assignment was kept in a set of sealed envelopes, each bearing only the case number on the outside.

Full medical and surgical history were taken. Laboratory investigations were revised. Visual analogue scale was educated to the patient before the start of the operation.

One liter of lactated Ringer's solution was infused IV over 15 min during the neuraxial procedure.

The procedure was performed in the seated position. Parturients with VAS < 5 were excluded.

The procedure was performed by a senior anesthesia resident.

Before administering medications through the epidural catheter, subarachnoid, intravascular and subdural placement had to be ruled out.

After 5 min of the first initial bolus dose, adequacy of analgesia was assessed.

Analgesia was considered adequate if VAS score is ≤3. Onset of analgesia was defined as from time of first bolus dose to time of achieving VAS ≤3.

Patient with VAS score >3; considered failed block and were excluded from the study.

Analgesia was evaluated by a blinded observer assessing visual analog scale (VAS) pain scores, onset of analgesia, sensory level, and motor blockade.

The primary outcome was the onset of analgesia (defined as duration from injection of the first initial epidural bolus to attainment of VAS <3).

Other data collected are:

  1. Patients' demographic data.
  2. Obstetrics data.
  3. Onset of analgesia (attainment of VAS <3).
  4. HR and MABP (baseline, every 5 minutes until 15 mins, a every 15 mins till 1 hour and then every 1 hour till delivery).
  5. Visual analogue scale (VAS) with hemodynamics.
  6. Assessment of sensory level after 30 mins of the block.
  7. Assessment of Sacral block during the 1st 30 minutes.
  8. Assessment of motor block through the modified bromage scale
  9. Occurrence of side effects as: Hypotension, bradycardia, nausea, vomiting and pruritis ,PDPH, nerve injury.

Study Type

Interventional

Enrollment (Actual)

81

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 Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Medidcne, Cairo Univerisity

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

Yes

Description

Inclusion Criteria:

  • ASAI & II parturient in active labor
  • Uncomplicated pregnancy with vertex presentation
  • Willing to participate in the study.

Exclusion Criteria:

  • Patient's refusal
  • Coagulopathy (INR> 1.5 and platelets < 80,000)
  • Allergy to local anesthetics.
  • Prior surgery in lumbosacral spine.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional epidural group

Conventional epidural.

.
Procedure: Epidural analgesia
Epidural analgesia alone or with dural puncture with different sizes of spinal needles
Other Names:
  • Dural puncture
Active Comparator: DPE-25G group
Dural puncture epidural with 25-gauge spinal needle.
Procedure: Epidural analgesia
Epidural analgesia alone or with dural puncture with different sizes of spinal needles
Other Names:
  • Dural puncture
Active Comparator: DPE-27G group
Dural puncture epidural with 27-gauge spinal needle.
Procedure: Epidural analgesia
Epidural analgesia alone or with dural puncture with different sizes of spinal needles
Other Names:
  • Dural puncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of analgesia
Time Frame: 20 minutes
Duration from injection of the first initial epidural bolus dose to attainment of VAS <3
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of analgesia
Time Frame: 5 hours
Visual Analogue Score (0-10)
5 hours

Collaborators and Investigators

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

Sponsor

Cairo 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 (Actual)

January 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • spinal needle sizes and DPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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