Back to resultsDifferent Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia
Primary Purpose
Labor Pain, Epidural Analgesia
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
25G Dural Puncture Epidural Block
27G Dural Puncture Epidural Block
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring Labor analgesia, Dural puncture epidural, Postdural puncture headache, Neuraxial analgesia
Eligibility Criteria
Inclusion Criteria:
- healthy pregnant woman
- singleton and vertex presentation
- 37-42 weeks of gestational age
- active labor with cervical dilation < 5cm
- body mass index between 20 and 35 kg/m2
- desired labor epidural analgesia
Exclusion Criteria:
- adults who are unable to give their own consent
- presence of any pregnancy-related disease (e.g., gestational hypertension, preeclampsia, gestational diabetes)
- known fetal anomalies
- increased risk of cesarean delivery (e.g., previous uterine rupture, previous cesarean delivery)
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- allergy to LA
- prior sacral or lumbar spine surgery
Sites / Locations
- Hospital Clínico Universidad de Chile
- Hospital La Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
25G Dural Puncture Epidural Block
27G Dural Puncture Epidural Block
Arm Description
Patients will receive a dural puncture epidural block with a 25 gauge spinal needle.
Patients will receive a dural puncture epidural block with a 27 gauge spinal needle.
Outcomes
Primary Outcome Measures
Time to pain ≤ 1 on NRS (0-10)
Time elapsed between the end of local anesthetic injection and achievement of pain ≤ 1 on the NRS (measured every 2 minutes)
Secondary Outcome Measures
Gestational age
Gestational age at the time of recruitment
Obstetric history
Number of previous pregnancies and deliveries
Type of labor
Spontaneous versus induced labor
Oxytocin dose
Oxytocin infusion/dose at time of DPE
Cervical dilation
Cervical dilation at the time of DPE
State of membrane
Intact versus ruptured membrane at the time of DPE
Pre-DPE level of pain
Evaluated with a NRS from 0 to 10
Amount of IV fluids
Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery)
Intervertebral level of puncture
Lumbar interspace where DPE was successfully performed
Number of DPE attempts
Number of attempts for successful DPE
Incidence of accidental dural puncture
Incidence of accidental dural puncture with the epidural Tuohy needle
Performance time
Temporal interval between skin disinfection and epidural catheter fixation to the skin
Sensory block height
Sensory block height at 30 minutes after local anesthetic injection
Bilateral S2 sacral root block
Measured every 2 minutes after local anesthetic injection
Presence of motor block
Evaluated using a modified Bromage score
Number of epidural top-ups during labor
Number of extra doses of local anesthetic given after DPE up to delivery
Type of delivery
Incidence of Cesarean section, normal delivery, and instrumented delivery
Incidence of epidural catheter adjustment or replacement
Necessity of adjustment or replacement of the epidural catheter
DPE side effects
Incidence of nausea, pruritus, hypotension
Fetal-Uterine assessment
Frequency of contractions, uterine tonus, fetal heart rate tracing
Tocolysis requirement
Necessity to administer a tocolytic agent after DPE
Apgar scores
Assessment of newborn condition
DPE complications
Incidence of post dural puncture headache, back pain, paresthesia and motor deficit
Epidural blood patch incidence
Necessity of performing of a blood patch to relieve post dural puncture headache symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03389945
Brief Title
Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia
Official Title
Dural Puncture Epidural For Early Labor Analgesia: A Randomized Comparison Between 27- and 25-Gauge Pencil Point Spinal Needles.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 13, 2018 (Actual)
Primary Completion Date
March 12, 2019 (Actual)
Study Completion Date
March 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The rationale behind the dural puncture epidural (DPE) technique lies in the fact that a dural perforation with a spinal needle purportedly creates a conduit for accelerated translocation of local anesthetics from the epidural to the subarachnoid space. When compared with conventional epidural block, it provides improved sacral block and onset of analgesia.
Despite the benefits associated, the supportive literature remains scarce. No trial has determined if similar results could be obtained with a smaller needle.
In this trial, DPE using 25- and 27-gauge (G) spinal needles are compared. The main outcome will be the time required to obtain a pain score ≤ 1 using a 0-10 numeric rating scale (NRS). The hypothesis is that that both needle sizes will result in similar onset times and therefore designing the current study as an equivalence trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Epidural Analgesia
Keywords
Labor analgesia, Dural puncture epidural, Postdural puncture headache, Neuraxial analgesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25G Dural Puncture Epidural Block
Arm Type
Active Comparator
Arm Description
Patients will receive a dural puncture epidural block with a 25 gauge spinal needle.
Arm Title
27G Dural Puncture Epidural Block
Arm Type
Experimental
Arm Description
Patients will receive a dural puncture epidural block with a 27 gauge spinal needle.
Intervention Type
Procedure
Intervention Name(s)
25G Dural Puncture Epidural Block
Intervention Description
Dural puncture epidural analgesia using a 25G pencil point spinal needle at a lumbar interspace.
Then 20ml of bupivacaine 0.125% + fentanyl 2ug/ml will be injected in the epidural space.
Intervention Type
Procedure
Intervention Name(s)
27G Dural Puncture Epidural Block
Intervention Description
Dural puncture epidural analgesia using a 27G pencil point spinal needle at a lumbar interspace.
Then 20ml of bupivacaine 0.125% + fentanyl 2ug/ml will be injected in the epidural space.
Primary Outcome Measure Information:
Title
Time to pain ≤ 1 on NRS (0-10)
Description
Time elapsed between the end of local anesthetic injection and achievement of pain ≤ 1 on the NRS (measured every 2 minutes)
Time Frame
Up to 30 minutes after local anesthetic injection
Secondary Outcome Measure Information:
Title
Gestational age
Description
Gestational age at the time of recruitment
Time Frame
42 weeks
Title
Obstetric history
Description
Number of previous pregnancies and deliveries
Time Frame
At the time of recruitment
Title
Type of labor
Description
Spontaneous versus induced labor
Time Frame
At the time of delivery
Title
Oxytocin dose
Description
Oxytocin infusion/dose at time of DPE
Time Frame
At the time of DPE
Title
Cervical dilation
Description
Cervical dilation at the time of DPE
Time Frame
At the time of DPE
Title
State of membrane
Description
Intact versus ruptured membrane at the time of DPE
Time Frame
At the time of DPE
Title
Pre-DPE level of pain
Description
Evaluated with a NRS from 0 to 10
Time Frame
Immediate before DPE
Title
Amount of IV fluids
Description
Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery)
Time Frame
24 hours
Title
Intervertebral level of puncture
Description
Lumbar interspace where DPE was successfully performed
Time Frame
At the time of DPE
Title
Number of DPE attempts
Description
Number of attempts for successful DPE
Time Frame
1 hour
Title
Incidence of accidental dural puncture
Description
Incidence of accidental dural puncture with the epidural Tuohy needle
Time Frame
1 hour
Title
Performance time
Description
Temporal interval between skin disinfection and epidural catheter fixation to the skin
Time Frame
1 hour
Title
Sensory block height
Description
Sensory block height at 30 minutes after local anesthetic injection
Time Frame
Up to 30 minutes after local anesthetic injection
Title
Bilateral S2 sacral root block
Description
Measured every 2 minutes after local anesthetic injection
Time Frame
Up to 30 minutes after local anesthetic injection
Title
Presence of motor block
Description
Evaluated using a modified Bromage score
Time Frame
Up to 30 minutes after local anesthetic injection
Title
Number of epidural top-ups during labor
Description
Number of extra doses of local anesthetic given after DPE up to delivery
Time Frame
After DPE up to delivery
Title
Type of delivery
Description
Incidence of Cesarean section, normal delivery, and instrumented delivery
Time Frame
Delivery
Title
Incidence of epidural catheter adjustment or replacement
Description
Necessity of adjustment or replacement of the epidural catheter
Time Frame
After DPE up to delivery
Title
DPE side effects
Description
Incidence of nausea, pruritus, hypotension
Time Frame
After DPE up to delivery
Title
Fetal-Uterine assessment
Description
Frequency of contractions, uterine tonus, fetal heart rate tracing
Time Frame
Before and up to 1 hour after DPE
Title
Tocolysis requirement
Description
Necessity to administer a tocolytic agent after DPE
Time Frame
Up to 1 hour after DPE
Title
Apgar scores
Description
Assessment of newborn condition
Time Frame
At 1 and 5 minutes after delivery
Title
DPE complications
Description
Incidence of post dural puncture headache, back pain, paresthesia and motor deficit
Time Frame
After DPE up to 7 days postpartum
Title
Epidural blood patch incidence
Description
Necessity of performing of a blood patch to relieve post dural puncture headache symptoms
Time Frame
Up to 1 week of followup
Other Pre-specified Outcome Measures:
Title
Demographic data
Description
Age, height, weight, BMI
Time Frame
At the time of recruitment
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
healthy pregnant woman
singleton and vertex presentation
37-42 weeks of gestational age
active labor with cervical dilation < 5cm
body mass index between 20 and 35 kg/m2
desired labor epidural analgesia
Exclusion Criteria:
adults who are unable to give their own consent
presence of any pregnancy-related disease (e.g., gestational hypertension, preeclampsia, gestational diabetes)
known fetal anomalies
increased risk of cesarean delivery (e.g., previous uterine rupture, previous cesarean delivery)
coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
allergy to LA
prior sacral or lumbar spine surgery
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Metropolitana
Country
Chile
Facility Name
Hospital La Florida
City
Santiago
State/Province
Región Metropolitana
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8610864
Citation
Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. doi: 10.1097/00000539-199605000-00028.
Results Reference
background
PubMed Identifier
18931227
Citation
Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.
Results Reference
background
PubMed Identifier
28067707
Citation
Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
Results Reference
background
PubMed Identifier
27035462
Citation
Tran DQ, Van Zundert TC, Aliste J, Engsusophon P, Finlayson RJ. Primary Failure of Thoracic Epidural Analgesia in Training Centers: The Invisible Elephant? Reg Anesth Pain Med. 2016 May-Jun;41(3):309-13. doi: 10.1097/AAP.0000000000000394.
Results Reference
background
PubMed Identifier
16249679
Citation
Thomas JA, Pan PH, Harris LC, Owen MD, D'Angelo R. Dural puncture with a 27-gauge Whitacre needle as part of a combined spinal-epidural technique does not improve labor epidural catheter function. Anesthesiology. 2005 Nov;103(5):1046-51. doi: 10.1097/00000542-200511000-00019.
Results Reference
background
PubMed Identifier
15321605
Citation
Landau R, Ciliberto CF, Goodman SR, Kim-Lo SH, Smiley RM. Complications with 25-gauge and 27-gauge Whitacre needles during combined spinal-epidural analgesia in labor. Int J Obstet Anesth. 2001 Jul;10(3):168-71. doi: 10.1054/ijoa.2000.0834.
Results Reference
background
PubMed Identifier
9637643
Citation
Beilin Y, Zahn J, Bernstein HH, Zucker-Pinchoff B, Zenzen WJ, Andres LA. Treatment of incomplete analgesia after placement of an epidural catheter and administration of local anesthetic for women in labor. Anesthesiology. 1998 Jun;88(6):1502-6. doi: 10.1097/00000542-199806000-00013.
Results Reference
background
PubMed Identifier
31118278
Citation
Contreras F, Morales J, Bravo D, Layera S, Jara A, Riano C, Pizarro R, De La Fuente N, Aliste J, Finlayson RJ, Tran DQ. Dural puncture epidural analgesia for labor: a randomized comparison between 25-gauge and 27-gauge pencil point spinal needles. Reg Anesth Pain Med. 2019 May 22:rapm-2019-100608. doi: 10.1136/rapm-2019-100608. Online ahead of print.
Results Reference
derived
Learn more about this trial
Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia
We'll reach out to this number within 24 hrs