Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Postoperative analgesia for supratentorial craniotomy: a randomised controlled trial
Acronym
Study hypothesis
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
Ethics committee of Cerrahpasa School of Medicine, 10/07/2013, ref: 83045809/18230
Study design
Prospective randomised double blind placebo controlled interventional single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
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
Phase
Drug names
Dexketoprofen
Paracetamol
Metamizol
Morphine
Primary outcome measures
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 trial start date
01/01/2013
Overall trial end date
01/01/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. American Society of Anesthesiology (ASA) classification I-II or III
2. Aged 18 - 70
2. Scheduled for elective supratentorial craniotomy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
83
Participant 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
Recruitment start date
01/07/2013
Recruitment end date
01/01/2015
Locations
Countries of recruitment
Turkey
Trial participating centre
University of Istanbul
Cerrahpasa School of Medicine
Istanbul
34000
Turkey
Funders
Funder type
University/education
Funder name
University of Istanbul (Turkey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Manuscript is due for submission to a journal.
Intention to publish date
01/01/2016
Participant level data
Other
Results - basic reporting
Publication summary