Condition category
Signs and Symptoms
Date applied
26/01/2016
Date assigned
01/02/2016
Last edited
26/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes