An interventional study of 25G Dural Puncture Epidural Block and 27G Dural Puncture Epidural Block in Labor Pain and Epidural Analgesia, sponsored by University of Chile. Completed at 2 sites in Chile. Open to female participants. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by University of Chile · Not applicable, Interventional, and Supportive care
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.
423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.
This study's enrollment of 140 is above the median of 100 across 347 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →University of Chile is the lead sponsor of 194 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive a dural puncture epidural block with a 25 gauge spinal needle.
Procedure: 25G Dural Puncture Epidural Block
Patients will receive a dural puncture epidural block with a 27 gauge spinal needle.
Procedure: 27G Dural Puncture Epidural Block
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.
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.
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)
Time frame: Up to 30 minutes after local anesthetic injection
Gestational age
Gestational age at the time of recruitment
Time frame: 42 weeks
Obstetric history
Number of previous pregnancies and deliveries
Time frame: At the time of recruitment
Type of labor
Spontaneous versus induced labor
Time frame: At the time of delivery
Oxytocin dose
Oxytocin infusion/dose at time of DPE
Time frame: At the time of DPE
Cervical dilation
Cervical dilation at the time of DPE
Time frame: At the time of DPE
State of membrane
Intact versus ruptured membrane at the time of DPE
Time frame: At the time of DPE
Pre-DPE level of pain
Evaluated with a NRS from 0 to 10
Time frame: Immediate before DPE
Amount of IV fluids
Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery)
Time frame: 24 hours
Intervertebral level of puncture
Lumbar interspace where DPE was successfully performed
Time frame: At the time of DPE
Number of DPE attempts
Number of attempts for successful DPE
Time frame: 1 hour
Incidence of accidental dural puncture
Incidence of accidental dural puncture with the epidural Tuohy needle
Time frame: 1 hour
Performance time
Temporal interval between skin disinfection and epidural catheter fixation to the skin
Time frame: 1 hour
Sensory block height
Sensory block height at 30 minutes after local anesthetic injection
Time frame: Up to 30 minutes after local anesthetic injection
Bilateral S2 sacral root block
Measured every 2 minutes after local anesthetic injection
Time frame: Up to 30 minutes after local anesthetic injection
Presence of motor block
Evaluated using a modified Bromage score
Time frame: Up to 30 minutes after local anesthetic injection
Number of epidural top-ups during labor
Number of extra doses of local anesthetic given after DPE up to delivery
Time frame: After DPE up to delivery
Type of delivery
Incidence of Cesarean section, normal delivery, and instrumented delivery
Time frame: Delivery
Incidence of epidural catheter adjustment or replacement
Necessity of adjustment or replacement of the epidural catheter
Time frame: After DPE up to delivery
DPE side effects
Incidence of nausea, pruritus, hypotension
Time frame: After DPE up to delivery
Fetal-Uterine assessment
Frequency of contractions, uterine tonus, fetal heart rate tracing
Time frame: Before and up to 1 hour after DPE
Tocolysis requirement
Necessity to administer a tocolytic agent after DPE
Time frame: Up to 1 hour after DPE
Apgar scores
Assessment of newborn condition
Time frame: At 1 and 5 minutes after delivery
DPE complications
Incidence of post dural puncture headache, back pain, paresthesia and motor deficit
Time frame: After DPE up to 7 days postpartum
Epidural blood patch incidence
Necessity of performing of a blood patch to relieve post dural puncture headache symptoms
Time frame: Up to 1 week of followup
Demographic data
Age, height, weight, BMI
Time frame: At the time of recruitment
Plan to share: No
Ran from Jan 2018 to primary completion in Mar 2019, 13 months.
Of 191 non-industry interventional studies with no phase under Labor Pain, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 13 months is above that.
Counting every sponsor, half of 193 studies reached it within 9 months; a quarter within 5 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.