Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy
Condition: Postoperative Quality of Recovery; Postoperative Migrainous Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Sumatriptan; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery; Single injection saline 0.5ml subcutaneously in recovery
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment