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Subcutaneous Sumatriptan for Treatment of Post-Operative Neurosurgical Pain

Subcutaneous Sumatriptan Use for Treatment of Post-Craniotomy Pain- Randomised Double Blinded Placebo controlled Trial

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000793213
Acronym
SUPS Trial
Enrollment
136
Registered
2018-05-10
Start date
2018-10-01
Completion date
2019-12-02
Last updated
2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Craniotomy is one of the common surgeries performed in the modern day and age with brain tumour being the seventh commonest diagnosed cancer in the world. There are multiple other surgical conditions being amenable to craniotomy: Resection of brain tumours and arteriovenous malformations, clipping of brain aneurysms and microvascular decompression for trigeminal neuralgia just to mention a few. Post-craniotomy pain is often under-treated and under-estimated. Both acute and chronic post craniotomy headaches have been found to be common and significant clinical phenomena. In cross-sectional studies of the immediate post-operative pain levels, post craniotomy pain incidence is at 60 percent, more common than generally assumed. Post-operative pain is a common factor in delayed mobilization, lengthened hospital stay, development of anxiety and depression as well as development of chronic pain. Opioids are still the mainstay of post-operative craniotomy pain management. However effective opioid analgesia administration for the purposes of pain relief can precipitate decreased respiration and hypercarbia. We plan to recruit a total of 136 patients in this parallel arm double- blind trial in order to test our hypothesis that patients receiving subcutaneous sumatriptan will have improved analgesia control and recovery scores post-operatively. We will follow up the patients at 30 days to assess these outcomes at the thirty day mark.

Interventions

The patient will be randomised to one of two groups: an active treatment or placebo control group. Intervention: After completion of the Craniotomy for a surgical condition, the patients in the active treatment group will be administered subcutaneous single dose of 6 mg sumatriptan for active management of post-operative pain. The site of administration will be chosen by the recovery nurse based on individual factors e.g. arm, abdomen, or leg. Following this pain will be re-assessed at five min

The patient will be randomised to one of two groups: an active treatment or placebo control group. Intervention: After completion of the Craniotomy for a surgical condition, the patients in the active treatment group will be administered subcutaneous single dose of 6 mg sumatriptan for active management of post-operative pain. The site of administration will be chosen by the recovery nurse based on individual factors e.g. arm, abdomen, or leg. Following this pain will be re-assessed at five minute intervals and the usual post-operative prescribed opioid regime will be administered. The usual immediate prescribed post-operative regime involves administration of the intravenous recovery protocol to be used in the recovery area. The medication chosen can be e.g. oxycodone, fentanyl or morphine at the discretion of the treating anaesthetist. If the patient is randomised, but medication is not administered, this will be recorded and data analysed on an intention to treat basis. Adherence with protocol compliance will be monitored through regular monthly study audits.

Sponsors

Austin Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All adult patients over 18 undergoing Craniotomy Fully autonomous and able to give a valid consent for surgery and this particular study, or have mild underlying cognitive impairment only with the consent being given by the next of kin.

Exclusion criteria

Not autonomous and unwilling to give a valid consent for surgery and this particular study, or have mild underlying cognitive impairment only, with the consent being withheld by the next of kin Craniotomy for cerebrovascular surgery (i.e. cerebral aneurysm or arteriovenous malformation) Previous Ischemic or Haemorrhagic CVA Unstable Angina or Previous AMI Severe Hepatic Impairment Uncontrolled Hypertension Previous Sensitivity to Sumatriptan Current Treatment with MAOI's Current Treatment with SSSRI's Emergency Re-Operative Craniotomy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026