Faculty of Medidcne, Cairo Univerisity
Cairo, Egypt
NCT Number: NCT06287047
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Cairo, Egypt
Exclusion criteria
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Epidural analgesia alone or with dural puncture with different sizes of spinal needles
Other names: Dural puncture
Time frame: 20 minutes
Duration from injection of the first initial epidural bolus dose to attainment of VAS <3
Time frame: 5 hours
Visual Analogue Score (0-10)
Cairo University
Other
The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block: Comparative Randomized Controlled Study
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