PainPhase 3NCT02428777
Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy
A Phase 3 study testing Tramadol and Diclofenac in people with Pain, run by Cairo University at 2 sites in Egypt.
Trial summary
The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during operative outpatient hysteroscopy. Women undergoing operative hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Tramadol and Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 2 sitesEgypt
- Study dates
- Apr 2015to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Indication for operative outpatient hysteroscopy like endometrial biopsy, endometrial polyp, uterine septum, intrauterine adhesions, and loop retrieval.
Who cannot join
- Known allergy to tramadol or diclofenac.
- Diabetes, hypertension, gastritis, peptic ulcer, cardiac, renal or liver disease.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
BeniSuef University hospitals
BeniSuef
Nesreen AA Shehata, MD, +2001227866337, nesoomar@yahoo.com
- Recruiting
Cairo university hospitals
Cairo
AbdelGany Hassan, MRCOG, MD, 002 01017801604, abdelgany2@gmail.com
AbdelGany MA Hassan, MRCOG, MD
About this study
Official title: Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial
The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during operative outpatient hysteroscopy. Women undergoing operative hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale
Read the detailed description
Hysteroscopic examination is currently the most informative investigation for patients with abnormal uterine bleeding and infertility. Outpatient hysteroscopy involves the use of miniaturized endoscopic equipment to directly visualise the endometrial cavity, without the need of formal theatre facilities, general or regional anaesthesia.
Outpatient hysteroscopy is increasingly being used as a cost-effective alternative to in-patient hysteroscopy under general anaesthesia. Like other outpatient gynaecological procedures, however, it has the potential to cause pain severe enough for the procedure to be abandoned.
Opioid analgesics are widely used for the control of moderate to severe pain. Tramadol hydrochloride, a synthetic opioid is an orally active, clinically effective centrally acting analgesic having a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents.
Diclofenac is a non steroidal anti inflammatory drug which inhibits the cyclooxygenase enzyme.
The study will be conducted in the outpatient hysteroscopy clinic in Cairo university hospitals. All patients attending the outpatient hysteroscopy clinic will be invited to participate in the study. The invitation will include a clear full explanation of the study and patients will provide oral consent. Written informed consent is not needed since the procedure and Patients will be included in the study if they give written consents.
Tramadol, diclofenac and placebo will be enclosed in sealed envelopes which will be numbered using computer generated random table. Neither the patient nor the physician will be aware of the drug used. 210 women will be categorized into 3 groups: Group I who will receive oral Tramadol 100mg (Trama®, Global Napi) orally 1 hour before the procedure, group II who will receive oral diclofenac 100mg (voltaren® 100, Novartis) 1 hour before the procedure, and group III who will receive an oral placebo.
Full history will be taken followed by general and local examination. The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be set at 100mm Hg.
The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 5Charr provided by Tecchno medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors provided by Tecchno medical GmbH.
- Conditions
- Pain
- Being tested
- Tramadol, Diclofenac, Placebo
- Keywords
- Hysteroscopy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Women will receive oral tramadol 100 mg 1 hour before the procedure.
DiclofenacDrug
Women will receive oral diclofenac 100 mg 1 hour before the procedure
PlaceboDrug
Women will receive an oral placebo 1 hour before the procedure
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Active comparator | Women will receive oral tramadol 100 mg 1 hour before the procedure Receives: Drug: Tramadol |
| Diclofenac | Active comparator | Women will receive oral diclofenac 100 mg 1 hour before the procedure Receives: Drug: Diclofenac |
| Placebo | Placebo comparator | Women will receive an oral placebo 1 hour before the procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during the procedure as measured by the visual analogue scale
Women will be asked to score their pain using a visual analogue scale
Measured: 5 minutes after starting the procedure
Pain after the procedure as measured by the visual analogue scale
Women will be asked to score their pain using a visual analogue scale
Measured: 30 minutes after completing the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdelGany Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428777
- Sponsor's protocol ID
- Hyst 5
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2015
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahmad G, Attarbashi S, O'Flynn H, Watson AJ. Pain relief in office gynaecology: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Mar;155(1):3-13. doi: 10.1016/j.ejogrb.2010.11.018. Epub 2011 Jan 20.
PubMed 21255900van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.
PubMed 17516956
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02428777
- Acronym / sponsor ID
- Hyst 5
- Conditions
- Pain
- Keywords
- Hysteroscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during operative outpatient hysteroscopy. Women undergoing operative hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale
Detailed description
Hysteroscopic examination is currently the most informative investigation for patients with abnormal uterine bleeding and infertility. Outpatient hysteroscopy involves the use of miniaturized endoscopic equipment to directly visualise the endometrial cavity, without the need of formal theatre facilities, general or regional anaesthesia.
Outpatient hysteroscopy is increasingly being used as a cost-effective alternative to in-patient hysteroscopy under general anaesthesia. Like other outpatient gynaecological procedures, however, it has the potential to cause pain severe enough for the procedure to be abandoned.
Opioid analgesics are widely used for the control of moderate to severe pain. Tramadol hydrochloride, a synthetic opioid is an orally active, clinically effective centrally acting analgesic having a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents.
Diclofenac is a non steroidal anti inflammatory drug which inhibits the cyclooxygenase enzyme.
The study will be conducted in the outpatient hysteroscopy clinic in Cairo university hospitals. All patients attending the outpatient hysteroscopy clinic will be invited to participate in the study. The invitation will include a clear full explanation of the study and patients will provide oral consent. Written informed consent is not needed since the procedure and Patients will be included in the study if they give written consents.
Tramadol, diclofenac and placebo will be enclosed in sealed envelopes which will be numbered using computer generated random table. Neither the patient nor the physician will be aware of the drug used. 210 women will be categorized into 3 groups: Group I who will receive oral Tramadol 100mg (Trama®, Global Napi) orally 1 hour before the procedure, group II who will receive oral diclofenac 100mg (voltaren® 100, Novartis) 1 hour before the procedure, and group III who will receive an oral placebo.
Full history will be taken followed by general and local examination. The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be set at 100mm Hg.
The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 5Charr provided by Tecchno medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors provided by Tecchno medical GmbH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Active comparator | Drug: TramadolWomen will receive oral tramadol 100 mg 1 hour before the procedure |
| Diclofenac | Active comparator | Drug: DiclofenacWomen will receive oral diclofenac 100 mg 1 hour before the procedure |
| Placebo | Placebo comparator | Drug: PlaceboWomen will receive an oral placebo 1 hour before the procedure |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Indication for operative outpatient hysteroscopy like endometrial biopsy, endometrial polyp, uterine septum, intrauterine adhesions, and loop retrieval.
Key exclusion criteria (2 listed)
- Known allergy to tramadol or diclofenac.
- Diabetes, hypertension, gastritis, peptic ulcer, cardiac, renal or liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolWomen will receive oral tramadol 100 mg 1 hour before the procedure. | Drug | Tramadol |
| DiclofenacWomen will receive oral diclofenac 100 mg 1 hour before the procedure | Drug | Diclofenac |
| PlaceboWomen will receive an oral placebo 1 hour before the procedure | Drug | Placebo |
Primary outcome
Pain during the procedure as measured by the visual analogue scale
Time frame: 5 minutes after starting the procedure
Women will be asked to score their pain using a visual analogue scale
Pain after the procedure as measured by the visual analogue scale
Time frame: 30 minutes after completing the procedure
Women will be asked to score their pain using a visual analogue scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Background: PubMed 21255900Ahmad G, Attarbashi S, O'Flynn H, Watson AJ. Pain relief in office gynaecology: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Mar;155(1):3-13. doi: 10.1016/j.ejogrb.2010.11.018. Epub 2011 Jan 20.
- Background: PubMed 17516956van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol and Diclofenac in people with Pain, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AbdelGany M Hassan, MRCOG, MD (+201017801604, abdelgany2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during the procedure as measured by the visual analogue scale (time frame: 5 minutes after starting the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02428777, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.