The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
elective laparoscopic gastro-intestinal surgery in adults
Secondary outcome
Opioid-use in the post-operative phase, side-effects of opioids, mobilisation,
, patient-satisfactory, difficulty of surgery, compliance of the abdominal wall
during surgery and NK-cell activity
Background summary
There is a lot of interest in increasing the speed of recovery after a surgery.
Many programs have been initiated to this purpose, one of its' most known is
ERAS (Enhanced Recovery After Surgery). In this program, advices are given in
order to pursue a quick recovery. An important aspect within ERAS is
post-operative analgesia. When pain is well treated, there is a decreased risk
of pneumonia, less stress-respons resulting in a favourable cardial
oxygen-balance and less ileus, all resulting in a quicker recovery.
For open abdominal surgery (laparotomy), the thoracic epidural analgesia is the
golden standard. However, for laparoscopic surgery, the thoracic epidural
results in prolonged hospital stay, probably because the pain in laparoscopic
surgery is not as hard as in laparotomic surgery. Ergo, the risks of the
thoracic epidural does not seem to outweigh the benefits in laparoscopic
surgery.
An alternative is the Patient Controlled Analgesia-pump (PCA-pump), in which
the patient supplies itself with intravenous opioid, based on a preset manner.
Although the analgetics effect are very well, it has side-effects as sedation,
itch, nausea and ileus. These side effects are dependent on the amount of
opioids administered.
Recently, there is an increasing attention for administering intrathecal
opioids by a single shot spinal. Potential benefits as oppose to the thoracic
epidural is a the single shot technique instead of catheter resulting in less
infection-risk, the possibility for a quicker mobilisation, and still results
in very high levels of analgesia. In regard to the PCA-pump is that there will
be less need of systemic opioids, and thus resulting in less side-effects.
Furthermore, there are suggestions that spinal anesthesia results in a higher
oxygen delivery to the bowels, and probably gives a better healing with less
complications.
The method of a single shot opioid is well known, it has been used by caesarian
sections and orthopedic surgery. In laparoscopic surgery, as an addition to
general anesthesia, it has only been investigated in 3 studies. Although these
studies show very promising results, by methodological issues these results
cannot be transfered to the Dutch situation.
Kong et al. have compared spinal bupivacaine vs. bupivacaine/morphine in
laparoscopic gastro-intestinal surgery. They noticed higher levels of analgesia
in the first 48 hours after surgery. However, they did not report if it
resulted in a shorter hospital stay or quicker mobilisation and the study was
not performed in an ERAS-setting.
Virlos et al. compared the thoracic epidural vs. the single shot spinal
bupivacaine/diamorphine in an observational study, based on a change of
practise. They reported better analgesia, a quicker mobilisation and a earlier
hospital discharge in the spinal-group.
Wongyingsinn et al. have compared the single shot spinal with
bupivacaine/morphine vs. the PCA-pomp and noticed a better analgesia in the
first 24 hours, but no earlier discharge or mobilisation. However, this study
was probably underpowered to detect an effect on length of hospital stay, and
the additional (on demand) analgetics in the single shot spinal group were
different than the general Dutch practise.
There is an issue of which opioid to use. Many different opioids can and are
used intrathecally in daily practise. For a prolonged effect, a hydrophilic
opioid is required, because of the slower diffusion. In the Netherlands,
morphine is the most used hydrophilic opioid, that is registered for spinal
administration. It has been well investigated, although its' dose remains an
issue for debate.
Hypothesis:
We expect that in laparoscopic gastro-intestinal surgery, a single shot spinal
with bupivacaine/morfine will result in a beter analgesia in the first 48
hours. Hereby, the patients will require less systemic opioids, which will
decrease the side-effects. Furthermore, we expect the patients to recover
quicker and show an earlier mobilisation and a shorther hospital stay.
Study objective
The objective of this study is to determine if a single spinal shot of morphine
can decrease post-operative opioid-use, and thereby decrease opioid
side-effects and lead to a quicker recovery after surgery.
Study design
Single-blinded Randomized Controlled Trial
Intervention
A single spinal shot of bupivacaine/morphine
Study burden and risks
A single shot spinal injection, performed sterile and with local anesthesia.
The patients will be asked to fill in a diary during the hospital-stay.
Bloodsamples will be drawn on day 0, 1 and 3.
Maasstadweg 21
Rotterdam 3079DZ
NL
Maasstadweg 21
Rotterdam 3079DZ
NL
Listed location countries
Age
Inclusion criteria
Laparoscopic Gastro-intestinal surgery
Exclusion criteria
Bariatric surgery, rectal surgery, kidney-failure, Aorta-valve stenosis, coagulation disorders, emergency surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2013-001167-22-NL |
CCMO | NL43488.101.13 |
OMON | NL-OMON24841 |