Postoperative analgesia for supratentorial craniotomy
| ISRCTN | ISRCTN15818652 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15818652 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/04/2015
- Registration date
- 27/04/2015
- Last edited
- 27/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
People who have brain surgery (craniotomy) as part of their treatment are very likely to experience severe pain after the surgery. Controlling pain after surgery with pain killers is very important because it can keep the patient comfortable and may help them recover faster. The sooner people are up and about after an operation, the less likely they are to develop complications, such as blood clots or pneumonia. Unfortunately, there is no agreed way to treat pain in patients who have had craniotomy surgery. Morphine is a very strong pain killer which is most often used to relieve post-operative and severe pain. Morphine can be given to patients by using a patient-controlled analgesia (PCA) pump. The pump is computerised so that it safely permits the patient to push a button and receive small amounts of pain medicine into their intravenous (IV) drip. Morphine is not suitable for everyone and can react with a variety of other medications or medical conditions. The aim of this study is to test how well other pain killers work to help people manage pain after a craniotomy, alongside PCA morphine. This study will also see whether other pain killers can reduce the amount of morphine patients take after surgery, and look at the side effects people experience with morphine when they have taken other pain killers.
Who can participate?
Adults scheduled for supratentorial craniotomy surgery.
What does the study involve?
Participants are randomly allocated into one of four groups. Those in group 1 (intervention group) are given the pain killer dexketoprofen. Those in group 2 (intervention group) are given the pain killer paracetamol. Those in group 3 (intervention group) are given the pain killer metamizol. Those in group 4 (control group) are given a ‘dummy’ pain killer (saline). All participants have PCA pump morphine. Participants are assessed for pain for the first 24 hours after surgery.
What are the possible benefits and risks of participating?
The drugs used in this study are routinely used to treat postoperative pain. All potential side-effects are discussed with participants at the start of the trial.
Where is the study run from?
University of Istanbul (Turkey)
When is the study starting and how long is it expected to run for?
January 2013 to January 2015
Who is funding the study?
University of Istanbul (Turkey)
Who is the main contact?
Professor O Korkmaz Dilmen
Contact information
Scientific
University of Istanbul
Cerrahpasa School of Medicine
Department of Anesthesiology
Kocamustafapasa
İstanbul
34000
Türkiye
Study information
| Study design | Prospective randomised double blind placebo controlled interventional single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Postoperative analgesia for supratentorial craniotomy: a randomised controlled trial |
| Study objectives | The prevalence of moderate to severe pain is high in patients following craniotomy. Optimal analgesic therapy is very important as pain may cause severe problems. However, there is no consensus regarding analgesic regimen for post-craniotomy pain. The aim of this study is to investigate the effects of morphine and non-opioid analgesics on post-craniotomy pain. |
| Ethics approval(s) | Ethics committee of Cerrahpasa School of Medicine, 10/07/2013, ref: 83045809/18230 |
| Health condition(s) or problem(s) studied | Post-supratentorial craniotomy pain |
| Intervention | Participants are allocated to one of four groups. All patients receive morphine-based patient controlled analgesia for 24 hours following surgery, in addition to one of the following: 1. Intravenous dexketoprofen (50mg) 2. Intravenous paracetamol (1g) 3. Intravenous metamizol (1g) 4. Intravenous saline (0.9%) (placebo) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | Dexketoprofen Paracetamol Metamizol Morphine |
| Primary outcome measure | Pain intensity is assessed during the first 24 hours post-surgery using the visual analogue scale (VAS) (at the 10th minute, 1, 2, 6, 12, and 24 hours postoperatively). |
| Secondary outcome measures | Assessed during the first 24 hours post-surgery (at the 10th minute, 1, 2, 6, 12, and 24 hours postoperatively): 1. Morphine consumption 2. Morphine-related side effects 3. Ramsay Sedation Scale (RSS) 4. Blood pressure 5. Heart/respiratory rate |
| Overall study start date | 01/01/2013 |
| Completion date | 01/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 83 |
| Key inclusion criteria | 1. American Society of Anesthesiology (ASA) classification I-II or III 2. Aged 18 - 70 2. Scheduled for elective supratentorial craniotomy |
| Key exclusion criteria | 1. Neurological disorders hindering communication 2. Aphasia 3. Glasgow Coma Score (GCS) less than 15 4. Drug or alcohol addiction 5. Chronic pain 6. Raised intracranial pressure 7. Allergies to any of the drugs used in this study 8. Hepatic or renal dysfunction 9. Peptic ulcer disease 10. Dementia |
| Date of first enrolment | 01/07/2013 |
| Date of final enrolment | 01/01/2015 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Istanbul
34000
Türkiye
Sponsor information
Hospital/treatment centre
Cerrahpasa School of Medicine
Kocamustafapasa
İstanbul
34000
Türkiye
"ROR" |
https://ror.org/03a5qrr21 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/01/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Manuscript is due for submission to a journal. |
| IPD sharing plan |
