PainPhase 2NCT02068209
Evaluation of the Role of Tramadol 50mg as an Analgesic During Outpatient Hysteroscopy
A Phase 2 study testing Tramadol in people with Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during outpatient hysteroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to Mar 2015
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for outpatient hysteroscopy
- Consent to the procedure
Who cannot join
- Premenstrual patients
- Known cardiac disease
- Known allergy to Tramadol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Tramadol 50mg in Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial.
The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during outpatient hysteroscopy.
Read the detailed description
This study is a prospective double blinded randomised controlled trial. 140 women will be recruited from the office 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 written consents. Only patients consenting to participate will be included in the trial.
Tramadol and placebo will be enclosed in sealed envelopes which will be numbered using a computer generated random table. Neither the patient nor the physician will be aware of the drug used. Patients will be categorized into 2 groups: Group I who will receive Tramadol 50mg (Tramadol, October Pharma, Giza, Egypt) 1 hour before the procedure, group II who will received a placebo acting as the control group.
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 visualized, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.
Base line characteristics will be compared and the main outcome measure will be patients' pain perception during the procedure and 30 minutes later, this will be determined using a visual analogue scale.
- Conditions
- Pain
- Being tested
- Tramadol, Placebo
- Keywords
- Outpatient hysteroscopy, Tramadol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Also called Tramadol 50mg
patients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy.
PlaceboDrug
patients will receive a placebo 1 hour before outpatient hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Active comparator | Patients will receive Tramadol 50mg 1 hour before outpatient hysteroscopy Receives: Drug: Tramadol |
| Placebo | Placebo comparator | Patients will receive a 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 perceived by the patient during the procedure
Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.
Measured: 10 minutes after starting the procedure.
Secondary outcomes (1)
Pain perceived by the patient 30 minutes after the procedure.
The level of pain will be assessed 30 minutes after the procedure by a visual analogue scale.
Measured: 30 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdelGany Hassan, Cairo University
- Investigators
- AbdelGany MA Hassan, MRCOG, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068209
- Sponsor's protocol ID
- Gany-123
- Status last verified
- Apr 2015
- First submitted
- 16 Feb 2014
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Floris S, Piras B, Orru M, Silvetti E, Tusconi A, Melis F, Tuveri M, Piga M, Paoletti AM, Melis GB. Efficacy of intravenous tramadol treatment for reducing pain during office diagnostic hysteroscopy. Fertil Steril. 2007 Jan;87(1):147-51. doi: 10.1016/j.fertnstert.2006.05.072. Epub 2006 Nov 1.
PubMed 17081540Sharma JB, Aruna J, Kumar P, Roy KK, Malhotra N, Kumar S. Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy. Indian J Med Sci. 2009 Jun;63(6):244-52.
PubMed 19602758van 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 17516956O'Flynn H, Murphy LL, Ahmad G, Watson AJ. Pain relief in outpatient hysteroscopy: a survey of current UK clinical practice. Eur J Obstet Gynecol Reprod Biol. 2011 Jan;154(1):9-15. doi: 10.1016/j.ejogrb.2010.08.015.
PubMed 20926175Modi H, Mazumdar B, Bhatt J. Study of interaction of tramadol with amlodipine in mice. Indian J Pharmacol. 2013 Jan-Feb;45(1):76-9. doi: 10.4103/0253-7613.106440.
PubMed 23543914
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Tramadol 50mg in Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT02068209
- Acronym / sponsor ID
- Gany-123
- Conditions
- Pain
- Keywords
- Outpatient hysteroscopy, Tramadol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Feb 2014 (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 evaluate the role of Tramadol 50mg in reducing pain during outpatient hysteroscopy.
Detailed description
This study is a prospective double blinded randomised controlled trial. 140 women will be recruited from the office 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 written consents. Only patients consenting to participate will be included in the trial.
Tramadol and placebo will be enclosed in sealed envelopes which will be numbered using a computer generated random table. Neither the patient nor the physician will be aware of the drug used. Patients will be categorized into 2 groups: Group I who will receive Tramadol 50mg (Tramadol, October Pharma, Giza, Egypt) 1 hour before the procedure, group II who will received a placebo acting as the control group.
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 visualized, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.
Base line characteristics will be compared and the main outcome measure will be patients' pain perception during the procedure and 30 minutes later, this will be determined using a visual analogue scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Active comparator | Drug: TramadolPatients will receive Tramadol 50mg 1 hour before outpatient hysteroscopy |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a placebo 1 hour before the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred for outpatient hysteroscopy
- Consent to the procedure
Key exclusion criteria (3 listed)
- Premenstrual patients
- Known cardiac disease
- Known allergy to Tramadol
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 |
|---|---|---|
| TramadolAlso: Tramadol 50mgpatients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy. | Drug | Tramadol |
| Placebopatients will receive a placebo 1 hour before outpatient hysteroscopy | Drug | Placebo |
Primary outcome
Pain perceived by the patient during the procedure
Time frame: 10 minutes after starting the procedure.
Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.
1 secondary outcome
Pain perceived by the patient 30 minutes after the procedure.
Time frame: 30 minutes after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Background: PubMed 17081540Floris S, Piras B, Orru M, Silvetti E, Tusconi A, Melis F, Tuveri M, Piga M, Paoletti AM, Melis GB. Efficacy of intravenous tramadol treatment for reducing pain during office diagnostic hysteroscopy. Fertil Steril. 2007 Jan;87(1):147-51. doi: 10.1016/j.fertnstert.2006.05.072. Epub 2006 Nov 1.
- Background: PubMed 19602758Sharma JB, Aruna J, Kumar P, Roy KK, Malhotra N, Kumar S. Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy. Indian J Med Sci. 2009 Jun;63(6):244-52.
- 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.
- Background: PubMed 20926175O'Flynn H, Murphy LL, Ahmad G, Watson AJ. Pain relief in outpatient hysteroscopy: a survey of current UK clinical practice. Eur J Obstet Gynecol Reprod Biol. 2011 Jan;154(1):9-15. doi: 10.1016/j.ejogrb.2010.08.015.
- Background: PubMed 23543914Modi H, Mazumdar B, Bhatt J. Study of interaction of tramadol with amlodipine in mice. Indian J Pharmacol. 2013 Jan-Feb;45(1):76-9. doi: 10.4103/0253-7613.106440.
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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.
AbdelGany MA Hassan, MRCOG, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tramadol in people with Pain, run by Cairo University at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perceived by the patient during the procedure (time frame: 10 minutes after starting the procedure.). 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 NCT02068209, which also lists 5 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 6 Apr 2015.