Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287047
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-23
Brief Title:
The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block Comparative Randomized Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Patients refusal
Eighty-one patients meeting the inclusion criteria were randomly divided into three equal groups
Group CE n27 Conventional epidural Group DPE-25 n27 Dural puncture epidural with 25-gauge spinal needle Group DPE-27 n27 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 Ringers 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
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
Patients refusal
Eighty-one patients meeting the inclusion criteria were randomly divided into three equal groups
Group CE n27 Conventional epidural Group DPE-25 n27 Dural puncture epidural with 25-gauge spinal needle Group DPE-27 n27 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 Ringers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None