The efficiency of tramadol, oxycodone and piritramide after an ambulatory gynaecological surgery

ISRCTN	ISRCTN10367446
DOI	https://doi.org/10.1186/ISRCTN10367446
Protocol serial number	N/A
Sponsors	University of Antwerp, Anenis, University of Antwerp
Funder	AZ Nikolaas

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Mrs Jelle Vermorgen
Scientific

Anenis
Moerlandstraat 1
Sint-niklaas
9100
Belgium

Phone	+32 3 760 85 48
Email	jelle.vermorgen@aznikolaas.be

Dr Charlotte Stolte
Scientific

Anenis
Moerlandstraat 1
Sint-Niklaas
9100
Belgium

Phone	+32 3 760 85 48
Email	Charlotte.Stolte@aznikolaas.be

Mrs Nele Tulkens
Scientific

Anenis
Moerlandstraat 1
Sint-Niklaas
9100
Belgium

Phone	+32 3 760 85 48
Email	Nele.Tulkens@aznikolaas.be

Prof Bart Van Rompaey
Scientific

University of Antwerp
Universiteitsplein 1
Antwerp
2610
Belgium

Phone	+32 3 760 85 48
Email	Bart.VanRompaey@uantwerpen.be

Study information

Primary study design	Interventional
Study design	Prospective single-centre double-blind randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase
Drug / device / biological / vaccine name(s)	1. Tramadol 2. Oxycodone 3. Piritramide
Primary outcome measure(s)	Post-operative pain is measured using the Numeric Rating Scale (NRS) immediately after surgery (in the recovery room) and before hospital discharge.
Key secondary outcome measure(s)	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
Completion date	31/05/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	300
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

AZ Nikolaas

Moerlandstraat 1
Sint-Niklaas
9100
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes