Condition category
Signs and Symptoms
Date applied
17/04/2015
Date assigned
27/04/2015
Last edited
27/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Professor Ozlem Korkmaz Dilmen

ORCID ID

Contact details

University of Istanbul
Cerrahpasa School of Medicine
Department of Anesthesiology
Kocamustafapasa
İstanbul
34000
Turkey

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

Sponsor information

Organisation

University of Istanbul

Sponsor details

Cerrahpasa School of Medicine
Kocamustafapasa
İstanbul
34000
Turkey

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes