The efficiency of tramadol, oxycodone and piritramide after an ambulatory gynaecological surgery
| ISRCTN | ISRCTN10367446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10367446 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/01/2016
- Registration date
- 01/02/2016
- Last edited
- 26/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
Anenis
Moerlandstraat 1
Sint-niklaas
9100
Belgium
| Phone | +32 3 760 85 48 |
|---|---|
| jelle.vermorgen@aznikolaas.be |
Scientific
Anenis
Moerlandstraat 1
Sint-Niklaas
9100
Belgium
| Phone | +32 3 760 85 48 |
|---|---|
| Charlotte.Stolte@aznikolaas.be |
Scientific
Anenis
Moerlandstraat 1
Sint-Niklaas
9100
Belgium
| Phone | +32 3 760 85 48 |
|---|---|
| Nele.Tulkens@aznikolaas.be |
Scientific
University of Antwerp
Universiteitsplein 1
Antwerp
2610
Belgium
| Phone | +32 3 760 85 48 |
|---|---|
| Bart.VanRompaey@uantwerpen.be |
Study information
| Study design | Prospective single-centre double-blind randomized controlled trial |
|---|---|
| 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 the contact details below to request a patient information sheet. |
| Scientific title | The efficiency of tramadol, oxycodone and piritramide after an ambulatory gynaecological surgery: A randomised controlled trial |
| Study objectives | Tramadol and oxycodone lower the prevalence of postoperative nausea, vomiting and dizziness in patients undergoing ambulatory gynaecological surgery compared to piritramide. |
| Ethics approval(s) | Ethical board of the hospital in Sint-Niklaas, ref: EC 15033 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | 1. Tramadol 2. Oxycodone 3. Piritramide |
| Primary outcome measure | 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 study start date | 12/03/2015 |
| Completion date | 31/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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. |
| Key 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 |
| Key exclusion criteria | 1. Chronic pain 2. Mental disorder 3. Allergy Paracetamol, Tramadol, Oxycodon and/or Piritramide 4. Pregnancy 5. Breastfeeding 6. Emergency procedures |
| Date of first enrolment | 16/11/2015 |
| Date of final enrolment | 15/04/2016 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Sint-Niklaas
9100
Belgium
Sponsor information
University/education
Faculty of Medicine and Healthcare
Division of Nursing Science and Midwifery
Universiteitsplein 1
Antwerp
2610
Belgium
Hospital/treatment centre
Moerlandstraat 1
Sint-Niklaas
9100
Belgium
Not defined
| Website | https://www.uantwerpen.be/en/ |
|---|---|
"ROR" |
https://ror.org/008x57b05 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/09/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of results immediately after the statistical analysis. |
| IPD sharing plan |
