Parturients Clinical Trial
Official title:
A Randomized, Prospective Study to Establish Whether the Instillation of 10ml of Epidural Normal Saline Improves the Quality Of Epidural Analgesia During Labor
In current obstetric anesthesia practice, epidural analgesia is the most effective technique
to control labor pain for those women who request pain-free delivery. Epidural analgesia not
only allows us to obtain greater pain relief and increased satisfaction of mothers, but also
permits us to convert it to regional anesthesia in case of operative delivery, avoiding
general anesthesia.
One of the major concerns with epidural anesthesia in labor setting is the inability to
produce an intensive analgesia or adequate level to proceed with cesarean section. This
study is designed to examine the hypothesis that 10ml epidural normal saline to reduce rate
of one-side block, low segmental block, and patch block, and improve quality of labor
epidural analgesia/ anesthesia in obstetric population.
One of the major concerns with epidural anesthesia in labor setting is the inability to
produce an intensive analgesia or adequate level to proceed with cesarean section. The
incidence of this event is rather various among reports, reflecting variability in
definitions, authors' clinical judgment and perception, practice parameters, hospital
settings. In most of related studies, the term of incomplete block was used and defined as
(1) unilateral block; (2) unblocked sacral segments; (3) low level; (4) unblocked segments
or a patchy block. 1Reported incidence of inadequate analgesia/anesthesia was 18% to 31.8%.
In addition, the reported incidence of intraoperative discomfort/visceral pain was from 10%
to 56%.1
If the anesthesia/analgesia is not adequate, other treatment modalities have to be provided
to improve pain relief, these include intravenous narcotics or ketamine, replacements of
epidural catheter, or general anesthesia, the risks of complications may be increased by
those managements.
The etiology and mechanisms of failed or dysfunctional epidural analgesia or anesthesia in
obstetrics are complex, multifactorial, and not entirely understood. Depending on the
situation, the causes might be evident or puzzling and difficult to explain.
Injection of fluid is frequently used for identification of the epidural space by the
loss-of-resistance (LOR) technique. It has been shown that different volumes of saline may
affect the subsequent epidural analgesia. Iwama showed that using 10 mL of saline as
compared to two mL in patients undergoing elective surgery during lumbar epidural anesthesia
with 2% mepivacaine resulted in a greater extent of anesthesia.2 Also, Okutomi et al
examined the effect of saline volume on anesthetic levels and quality of thoracic epidural
block in patients undergoing upper abdominal surgery. They demonstrated that the block level
for cold after mepivacaine 1.5% was proportional to the saline volume injected, whereas the
block level for pain was independent of the saline solution.3 Identifying the epidural space
by a lost of resistance to air method is thought to increase the incidence of inadequate
anesthesia. A randomized study, comparing air versus saline to identify the epidural space
in parturients, found a higher incidence of inadequate analgesia in the air group (36%
versus 19%).4
In parturients requesting epidural analgesia, a few studies showed that 2- 10ml normal
saline giving to epidural space after LOR was obtained reduced the rate of venous puncture
and unblock segments to cold and pin prick, but did not improve the visual analog pain scale
or reduced the need for supplemental.3,5,6 No study on improvement of unilateral block,
patch block and patients' satisfaction in obstetric setting has been found.
We design this study to examine the hypothesis that 10ml epidural normal saline to reduce
rate of one-side block, low segmental block, and patch block, and improve quality of labor
epidural analgesia/ anesthesia in obstetric population.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00727935 -
Comparison Of The Analgesia Obtained By Infiltration For The Joinings Of Episiotomies (Liropep)
|
Phase 4 | |
| Recruiting |
NCT00811707 -
Epidural Sonoanatomy Between Parturient and Non-Pregnant
|
N/A |