Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01632657 |
| Other study ID # |
12-0139 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2012 |
| Est. completion date |
December 15, 2019 |
Study information
| Verified date |
December 2022 |
| Source |
University Health Network, Toronto |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Postoperative migrainous headache following craniotomy is distressing and may cause
significant morbidity and often delay discharge from the hospital. The mechanism of this post
craniotomy migraine is multifactorial. Possible causes include the intraoperative loss of
cerebrospinal fluid leading to stretching of the dura, traction on intracranial vessels and
meningeal irritation. There are two groups of patients who undergo elective minimally
invasive craniotomies and yet have considerable postoperative migraine headache
postoperatively. These are patients who have a craniotomy for clipping of an unruptured
cerebral aneurysm and patients who require a microvascular decompressive craniotomy for
cranial nerve pain such as trigeminal neuralgia. Their postoperative migrainous headache
often impairs the quality of their recovery and may even delay discharge from hospital.
Opioid analgesics are not always effective and may also worsen the postoperative nausea and
vomiting and in turn postoperative quality of their recovery. Sumatriptan is a drug that has
been used for decades for the treatment of migraine headaches. It acts on 5hydroxytryptophan
receptors, which are located in the dura mater (lining of the brain) and are also located
around the cranial trigeminal nerve ganglion. Thus sumatriptan may be an effective to improve
postoperative migraine , nausea and vomiting and overall quality of recovery. We plan to do a
randomized double blind placebo controlled trial on the effect of Sumatriptan for
postoperative migraine on the postoperative quality of recovery after elective minimally
invasive craniotomies. A total of 92 patients scheduled to undergo minimally invasive
craniotomy for either clipping of an unruptured aneurysm or microvascular decompression for
cranial nerve neuralgias will be included in this study. Patients within the 2 surgical
groups with postoperative migraine will then be block randomized to receive either 6mg of
sumatriptan subcutaneously or placebo following assessment in the post operative care unit
(PACU). The primary outcome measure will be quality of recovery at 24 hours using Quality of
recovery 40 Questionnaire (QoR-40). Our secondary outcome will be postoperative pain,
analgesic consumption, side effects and hospital discharge times.
Description:
Recently there have been changes in the surgical management of many patients who have an
unruptured cerebral aneurysm and or cranial nerve neuralgia pain. The surgical technique now
consists of a minimally invasive craniotomy that is less invasive with a smaller incision,
shorter duration of procedure and in some patients the possibility of going home the same
day, Postoperative surgical pain from the incision itself is usually minimal and they are
usually managed very well with combination of both opioid and non-opioid analgesics such as
fentanyl, morphine, hydromorphone, codeine, oxycocet, oxycontin and acetaminophen. In
addition, up to 65% patients undergoing craniotomy may suffer from post craniotomy headache
and the incidence may be higher after posterior fossa craniotomy. (1) Patients often complain
of severe migraine headache associated with photophobia, nausea and vomiting and general
feeling of unwell. These discomforts often delay discharge from the hospital and affect the
quality of recovery. (2,3) Post craniotomy surgical pain usually decreases significantly
after 24 hours whereas post craniotomy migraine headache, which may be a separate entity,
continues for a longer period of time. (4) This migraine headache is in different location
from the surgical incision and the conventional treatments of post surgical pain are
ineffective against migraine headache.(5) Hence these patients usually suffer a lot after
minimally invasive craniotomy. The mechanisms of postoperative migraine are also poorly
understood and may be multifactorial including raised intracranial pressure, traction on
intracranial blood vessels or meningeal irritation. (6) These factors activate the trigeminal
afferent C fibres that reside on pial and dural blood vessels. This causes transmission of
pain and release of neurogenic peptides activating an inflammatory cascade causing
vasodilation and perivascular inflammation. The loss of cerebrospinal fluid is another
factor.(7) With a minimally invasive craniotomy, loss of cerebrospinal fluid is unavoidable
as it is needed for better surgical access. Serotonin (5-hydroxytryptophan) is a
neurotransmitter that is thought to contribute to the feeling of wellbeing. There are
receptors for 5hydroxytryptophan (5-HT) located in the central nervous system especially in
the trigeminal nerve both near the dura as well as in brainstem (near the trigeminal nuclei)
and also located on vascular endothelium and smooth muscle in meningeal blood vessels as well
as in neuronal tissue.
