Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03258879 |
| Other study ID # |
10017388 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
July 12, 2017 |
| Last updated |
November 9, 2017 |
| Start date |
January 2018 |
| Est. completion date |
August 2018 |
Study information
| Verified date |
November 2017 |
| Source |
Western University, Canada |
| Contact |
Yamini Subramani, MD |
| Phone |
519-902-4715 |
| Email |
yaminisrs[@]rediffmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Epidural, Combined Spinal-Epidural, and more recently dural puncture epidural are forms of
neuraxial anesthesia used to provide pain relief in laboring women . The investigators want
to assess the onset of pain relief with 2 different neuraxial techniques performed at our
center, but which have not yet been compared in the literature: (1) Modified CSE, with only
local anesthetic injected into the spinal fluid to reduce side effects of opioids that are
seen with the traditional CSE and (2) Dural Puncture Epidural (DPE), involving puncture of
the spinal membrane, but without injection of medication into the spinal space. The
investigators hypothesize that the onset of labor analgesia will be faster with modified CSE
compared to DPE.
Description:
Purpose of the research:
- To determine the onset of effective analgesia (Numerical Rating Scale (NRS) for pain
- To assess block quality (time to T10 sensory block, motor block, asymmetric block,
inadequate block) between the 2 techniques.
- To assess incidence of breakthrough pain as determined by number of physician
interventions.
- To determine the incidence of side effects (maternal hypotension, pruritus, nausea, and
fetal bradycardia).
- To assess delivery outcomes (vaginal vs. instrumental vs. CS).
- To compare fetal Apgar scores.
- To assess maternal satisfaction with pain relief using Likert scale at 24h.
- To evaluate for potential complications (Post-dural puncture headache, back pain, leg
weakness, numbness and infection) related to the techniques at 24h.
Hypothesis:
The investigators hypothesize that the onset of effective analgesia (NRS pain
Methodology:
Study Design: Randomized Double Blinded Clinical Trial.
Study Implementation:
Once participants are consented for the study, usual care is established with IV cannula
insertion, fluid bolus and standard monitors will be applied. Participants will then be
randomly assigned into two groups by a computer-generated randomization sequence. Group
assignments will be concealed in opaque numbered envelopes and will be opened by the
anesthesiologist performing the block immediately before initiation of analgesia. Group 1
will receive a modified combined spinal-epidural (MCSE) and Group 2 will receive a dural
puncture epidural (DPE).
The epidural space will be located at the L2-3 or L3-4 interspace using a midline approach
with a 17-G, 9 cm Touhy epidural needle using a loss of resistance technique. A single dural
puncture with confirmation of free flow of CSF will be performed with a 25-G, 12 cm Whitacre
needle placed through the epidural needle. Subsequent intervention varies with the group
allocation.
MCSE group: 1 ml of 0.25% bupivacaine will be injected intrathecally DPE group: No medication
will be injected intrathecally. Both the groups will subsequently have the epidural catheter
placed 4-6 cm into the space and will be checked for a negative aspiration of blood/CSF. In
the DPE group, 15 ml of 0.125% bupivacaine will be given as 5ml fractionated boluses. Both
groups will have patient controlled epidural analgesia started after the study interventions
as follows: Bupivacaine 1.25 mg/mL with fentanyl 2 microgram/ml, background infusion at 8
mL/h, demand dose of 4 mL, lockout interval of 20 minutes.
The anesthesiologist and nurse will be asked not to reveal the group assignment to the
patient or study co-investigators so that the patients and the study investigators collecting
the data will be blinded to the techniques. The anesthesiologist performing the technique
will prepare the medications according to group allocation and will not be involved in any
data collection. Attending, fellow or resident anesthesiologists will perform all the
techniques.
After block completion, an independent blinded co-investigator will assess the numerical
rating scale (NRS) pain scores from 0-10 and other outcomes after the initial dosing, at the
2, 4, 6, 8, 10, 15, 20 and 30 minute marks. The time taken to achieve a NRS equal to or less
than 1 will be recorded for all the three groups. Sensory levels will be assessed using ice
starting caudad at the S2 dermatome and moving cephalad. Time taken to achieve a block of T10
will be recorded. Patients will be assessed for pruritus and nausea/vomiting every hour, by
grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 =
severe. Motor strength will be assessed hourly with a modified Bromage score (0 = full
flexion of knees and ankles, 1 = partial flexion of knees, full flexion of ankles, 2 =
inability to flex knees and partial flexion of ankles and 3 = inability to flex knees and
ankles). Presence of motor blockade will be defined as modified Bromage score of more than or
equal to 1. Following the first 30 minutes, assessments will continue at 60-minute intervals
until delivery.
The participant will be monitored for hypotension and fetal bradycardia during this period
and up to 1 hour after the procedure. Hypotension is defined as a 20% reduction in the
systolic blood pressure from the admission blood pressure in the absence of uterine
contraction and will be treated with vasopressors as per the standard of care. Fetal
bradycardia is defined as a fetal heart rate of less than 100 beats per minute, persisting
for more than 1 minute.
In the event of inadequate analgesia and a unilateral block defined by a difference of more
than 2 dermatomal levels between the 2 sides, the participant will be placed on the less
blocked side and a supplemental epidural dose will be administered. If the unilateral block
persists, the catheter will be withdrawn 1 cm and an additional supplemental epidural dose of
5 ml 2% lidocaine will be given over 2 min. In the event of inadequate analgesia and the
presence of inadequate sensory level bilaterally, supplemental epidural dose will be
administered. If improvement of analgesia is not observed, the epidural catheter will be
replaced.
Mode of delivery and fetal Agar scores will be recorded for all the patients. All the study
subjects will be visited on postpartum day 1 and will be assessed for satisfaction with labor
analgesia using a Likert scale and any potential complications such as headache, back pain,
leg weakness or numbness and paresthesia.
