Plain English Summary
Background and study aims
Gynaecological surgery is the term given to any surgical procedures on the female reproductive system. Procedures can range from minor (ambulatory) such as dilatation and curettage (a procedure where tissue is removed from the womb to diagnose or treat certain conditions) to major, such as hysterectomy (removal of the womb). Pain after gynaecological surgery is not uncommon, and often the medications used to relieve pain causes unwanted side effects such as nausea, vomiting and dizziness. In AZ Nikolaas hospital (Belgium), the usual medication used for post-operative pain relief following minor gynaecological surgery is piritramide, which is known for causing many side-effects. It is a very powerful medication, which works by binding to receptors in the brain and blocking the feeling of pain. Tramadol and oxycodone are similar pain killers which work in the same way, but are thought to cause fewer side effects. The aim of this study is to compare the effectiveness and post-operative side effects of tramadol and oxycodone to piritramide in the relief of post-operative pain in patients undergoing ambulatory gynaecological surgery.
Who can participate?
Women over 18 years of age who are having ambulatory gynaecological surgery.
What does the study involve?
All participants have their surgery performed under general anaesthesia (sedation) using the drugs propofol and sufentanil, and receive 2g paracetamol with 75mg diclofenac, 4mg ondansetron and 1,25mg droperidol for pain relief. Participants are randomly allocated to one of three groups. Those in the first group are given oxycodone after their procedure for pain relief. Those in the second group are given tramadol after their procedure for pain relief. Those in the third group are given piritramide after their procedure for pain relief. While the participants are in the recovery room, they complete several questionnaires in order to measure their pain levels and satisfaction with the drug they have been given. Participants are also observed throughout the length of their hospital stay in order to monitor any side effects such as nausea, vomiting and dizziness.
What are the possible benefits and risks of participating?
Participants may benefit from lower levels of pain after their surgery. The risks of participating include the general risks of side effects, such as nausea, vomiting and dizziness from the study medications.
Where is the study run from?
AZ Nikolaas (Belgium)
When is the study starting and how long is it expected to run for?
March 2015 to May 2016
Who is funding the study?
AZ Nikolaas (Belgium)
Who is the main contact?
1. Mrs Jelle Vermorgen (scientific)
Jelle.Vermorgen@aznikolaas.be
2. Dr Charlotte Stolte (scientific)
Charlotte.Stolte@aznikolaas.be
3. Mrs Nele Tulkens (scientific)
Nele.Tulkens@aznikolaas.be
4. Professor Bart Van Rompaey (scientific)
Bart.VanRompaey@uantwerpen.be
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Jelle Vermorgen
ORCID ID
Contact details
Anenis
Moerlandstraat 1
Sint-niklaas
9100
Belgium
+32 3 760 85 48
jelle.vermorgen@aznikolaas.be
Type
Scientific
Additional contact
Dr Charlotte Stolte
ORCID ID
Contact details
Anenis
Moerlandstraat 1
Sint-Niklaas
9100
Belgium
+32 3 760 85 48
Charlotte.Stolte@aznikolaas.be
Type
Scientific
Additional contact
Mrs Nele Tulkens
ORCID ID
Contact details
Anenis
Moerlandstraat 1
Sint-Niklaas
9100
Belgium
+32 3 760 85 48
Nele.Tulkens@aznikolaas.be
Type
Scientific
Additional contact
Prof Bart Van Rompaey
ORCID ID
Contact details
University of Antwerp
Universiteitsplein 1
Antwerp
2610
Belgium
+32 3 760 85 48
Bart.VanRompaey@uantwerpen.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The efficiency of tramadol, oxycodone and piritramide after an ambulatory gynaecological surgery: A randomised controlled trial
Acronym
Study hypothesis
Tramadol and oxycodone lower the prevalence of postoperative nausea, vomiting and dizziness in patients undergoing ambulatory gynaecological surgery compared to piritramide.
Ethics approval
Ethical board of the hospital in Sint-Niklaas, ref: EC 15033
Study design
Prospective single-centre double-blind randomized controlled trial
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 the contact details below to request a patient information sheet.
Condition
Postoperative pain, nausea and vomiting after ambulatory gynaecological surgery
Intervention
Following provision of informed consent, participants are randomly allocated to one of three groups using envelope randomisation.
Group 1: Participants are given oxycodone for post-operative pain relief.
Group 2: Participants are given tramadol for post-operative pain relief.
Group 3: Participants are given piritramide for post-operative pain relief.
All procedures under general anaesthesia were performed a standardized anaesthetic regimen. Anaesthesia was induced with propofol and sufentanil. All patients were placed on mechanical ventilation and anaesthesia was maintained using sevoflurane in oxygen-air. During the surgery, the patients were administered 2 gram paracetamol with 75mg diclofenac, 4mg ondansetron and 1,25mg droperidol. All the patients were observed in the recovery room.
Intervention type
Drug
Phase
Drug names
1. Tramadol
2. Oxycodone
3. Piritramide
Primary outcome measures
Post-operative pain is measured using the Numeric Rating Scale (NRS) immediately after surgery (in the recovery room) and before hospital discharge.
Secondary outcome measures
1. Postoperative nausea (PON) and/or vomiting (POV) is recorded post-operatively throughout length of hospital stay
2. Postoperative dizziness is measured through observations in the recovery room immediately after surgery
3. Patient satisfaction is measured using a 4-point Likert Scale immediately after surgery
Overall trial start date
12/03/2015
Overall trial end date
31/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Female
3. Ambulatory gynaecological surgery
4. Dutch speaking
5. General or spinal anesthesia
6. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
In this study, the aim is to obtain a minimum sample size of 300 patients with 100 patients in each arm.
Participant exclusion criteria
1. Chronic pain
2. Mental disorder
3. Allergy Paracetamol, Tramadol, Oxycodon and/or Piritramide
4. Pregnancy
5. Breastfeeding
6. Emergency procedures
Recruitment start date
16/11/2015
Recruitment end date
15/04/2016
Locations
Countries of recruitment
Belgium
Trial participating centre
AZ Nikolaas
Moerlandstraat 1
Sint-Niklaas
9100
Belgium
Sponsor information
Organisation
University of Antwerp
Sponsor details
Faculty of Medicine and Healthcare
Division of Nursing Science and Midwifery
Universiteitsplein 1
Antwerp
2610
Belgium
Sponsor type
University/education
Website
Organisation
Anenis
Sponsor details
Moerlandstraat 1
Sint-Niklaas
9100
Belgium
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
AZ Nikolaas
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of results immediately after the statistical analysis.
Intention to publish date
30/09/2016
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary