Pain, PostoperativeNCT04720248
Postoperative Pain in Scheduled Craniotomy
An observational study of Pain, Postoperative and Craniotomy, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
Trial summary
Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Craniotomy, Adverse Effect
- What is being tested?
- Metamizole
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 24 Feb 2021to 15 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old undergoing scheduled form for supratentorial craniotomy during the 8 months following the beginning of study at the center who can give informed consent and can be postoperatively evaluated by the acute pain unit.
Who may be able to join
- Patients over 18 years old undergoing scheduled form for supratentorial craniotomy.
- Signed informed consent.
Who cannot join
- Mini Mental State Examination with a score less than or equal to 24 points.
- Patients suffering from disabilities.
- Patients who can not collaborate in the postoperative clinical assessment.
- Patients who can not be assessed during the postoperative period by the Acute Pain Unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada
Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. Preoperative anxiety may be associated with a poorer postoperative analgesic control, hindering the adequate postoperative evolution and increasing hospital stay and adverse effects. In this observational study, the investigators aimed to assess the postoperative analgesic management in patients undergoing scheduled craniotomy following routine clinical practice and to relate preoperative anxiety with the postoperative analgesic evaluation in this population.
Read the detailed description
Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. On the other hand, preoperative anxiety may be associated with a poorer postoperative analgesic control and hinder the adequate postoperative evolution. The main outcome is to assess the postoperative analgesic management in patients undergoing to craniotomy. Secondary objectives are to evaluate the appearance of postoperative side effects related to the analgesics and to assess the relationship between preoperative anxiety and postoperative pain
- Conditions
- Pain, Postoperative, Craniotomy, Adverse Effect, Anxiety
- Being tested
- Metamizole
- Keywords
- postoperative pain, neurosurgery, craniotomy, anxiety
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetamizoleDrug
Patients will receive metamizole intraoperatively and throughout 48h postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Metamizol postoperatively | Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively Receives: Drug: Metamizole | |
| Paracetamol or other analgesics postoperatively | Patients submitted to scheduled craniotomy receiving paracetamol or other drugs as analgesic medication postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Using the Visual Analgesic Scale (from 0 to 10, with 0 being the state corresponding to "no pain" and 10 being the "maximum pain imaginable ") and postoperative analgesic satisfaction assessed by the patient (stratified in Bad, Fair, Good or Excellent).
Measured: 48 hours postoperatively
Secondary outcomes (2)
Side effects secondary to metamizol
Rate of appearance of postoperative side effects.
Measured: 48 hours postoperatively
To assess the correlation between preoperative anxiety and postoperative pain.
Relate the score obtained in the State Anxiety Inventory Trait (STAI) (from 0 to 60) with the intensity of postoperative pain (from 0 to 10).
Measured: From the day before surgery to the second day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start24 Feb 2021
- Primary completion30 Jun 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Aurelio Rodríguez Pérez, PhD, Study director, Hospital Universitario de Gran Canaria Doctor NegrínÁngel Becerra, MD, Principal investigator, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720248
- Sponsor's protocol ID
- Craneo-Negrín
- Status last verified
- Aug 2021
- First submitted
- 19 Jan 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be decided to be available to other researchers once the study ends.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada
- ClinicalTrials.gov ID
- NCT04720248
- Acronym / sponsor ID
- Craneo-Negrín
- Conditions
- Pain, Postoperative, Craniotomy, Adverse Effect, Anxiety
- Keywords
- postoperative pain, neurosurgery, craniotomy, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. Preoperative anxiety may be associated with a poorer postoperative analgesic control, hindering the adequate postoperative evolution and increasing hospital stay and adverse effects. In this observational study, the investigators aimed to assess the postoperative analgesic management in patients undergoing scheduled craniotomy following routine clinical practice and to relate preoperative anxiety with the postoperative analgesic evaluation in this population.
Detailed description
Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. On the other hand, preoperative anxiety may be associated with a poorer postoperative analgesic control and hinder the adequate postoperative evolution. The main outcome is to assess the postoperative analgesic management in patients undergoing to craniotomy. Secondary objectives are to evaluate the appearance of postoperative side effects related to the analgesics and to assess the relationship between preoperative anxiety and postoperative pain
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metamizol postoperatively | – | Drug: MetamizolePatients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively |
| Paracetamol or other analgesics postoperatively | – | –Patients submitted to scheduled craniotomy receiving paracetamol or other drugs as analgesic medication postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old undergoing scheduled form for supratentorial craniotomy during the 8 months following the beginning of study at the center who can give informed consent and can be postoperatively evaluated by the acute pain unit.
Key inclusion criteria (2 listed)
- Patients over 18 years old undergoing scheduled form for supratentorial craniotomy.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Mini Mental State Examination with a score less than or equal to 24 points.
- Patients suffering from disabilities.
- Patients who can not collaborate in the postoperative clinical assessment.
- Patients who can not be assessed during the postoperative period by the Acute Pain Unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetamizolePatients will receive metamizole intraoperatively and throughout 48h postoperatively. | Drug | Metamizol postoperatively |
Primary outcome
Postoperative pain
Time frame: 48 hours postoperatively
Using the Visual Analgesic Scale (from 0 to 10, with 0 being the state corresponding to "no pain" and 10 being the "maximum pain imaginable ") and postoperative analgesic satisfaction assessed by the patient (stratified in Bad, Fair, Good or Excellent).
2 secondary outcomes
Side effects secondary to metamizol
Time frame: 48 hours postoperatively
To assess the correlation between preoperative anxiety and postoperative pain.
Time frame: From the day before surgery to the second day postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: Undecided. IPD will be decided to be available to other researchers once the study ends.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelio Rodríguez Pérez, PhD study director
Hospital Universitario de Gran Canaria Doctor Negrín
Ángel Becerra, MD principal investigator
Hospital Universitario de Gran Canaria Doctor Negrín
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Craniotomy, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.