HysteroscopyPhase 3NCT02736071
Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy
A Phase 3 study testing Celecoxib and Tramadol in people with Hysteroscopy, run by Cairo University at 1 site in Egypt.
Trial summary
Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Celecoxib and Tramadol
- 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
- 1 siteEgypt
- Study dates
- Jun 2016to Apr 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Indication for operative outpatient hysteroscopy, indications will include endometrial biopsy, polypectomy, septum resection, intra-uterine device removal and adhesiolysis.
Who cannot join
- Submucous myomas.
- Known medical disorders like uncontrolled diabetes, hypertension, cardiac, renal or liver disease.
- Gastritis or peptic ulcer.
- Allergy to Tramadol or Celecoxib.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Cairo
AbdelGany MA Hassan, MRCOG, MD, 00217801604, abdelgany2@gmail.com
AbdelGany MA Hassan, MRCOG, MD
About this study
Official title: Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy: A Double Blind Placebo Controlled Trial.
Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.
Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).
Read the detailed description
Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.
All procedures will be scheduled to be done postmenstrual or after cessation of bleeding in case of metrorrhagia and will be done in the lithotomy position. The procedures will be performed using 30 degree angle 2.7 mm rigid hysteroscope with a 5mm outer diameter continuous flow hysteroscope with a 5 French working channel, a Teknolight 180 XA light source, and a Xenon high density fibre optic light cable 3.5mm, 2300mm Light cable without adaptors and a T Camera teknocam 2000S pro. All the equipment are provided by Tekno GmbH and Co®, Germany.
Vaginoscopic approach will be used for insertion of the hysteroscope in all cases. The hysteroscope will be gently introduced into the uterine cavity after visualization of the cervix and identification of the external os. Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. Patients will also be asked to report any side effects. The main outcome measure will be patients' pain perception during the procedure.
Statistics:
Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using ANOVA test for independent samples while categorical data will be compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.
Sample size calculation:
To the best of researchers knowledge this is the first trial to investigate the role of Celecoxib and oral Tramadol in reducing outpatient operative hysteroscopy associated pain, with no previous data to calculate the sample size with. Data from studies on diagnostic hysteroscopy cannot be applied because operative hysteroscopies need more manipulations and cause more pain. Assuming that the response will be normally distributed, the sample size is calculated to detect a mean difference of 1 unit between Tramadol and Celecoxib pain scores during the procedure (lower difference are not considered clinically relevant) using VAS assuming that the within group standard deviation will be 2. Investigators will need to study 64 cases in each group to be able to reject the null hypothesis that the population means of the Tramadol and Celecoxib are equal with probability (power) 0.8. Investigators added 6 cases to each arm accounting for any missing data and procedure failure ending in 70 cases in each group. The Type I error probability associated with this test of this null hypothesis is 0.05 using Student's t test for independent samples. Sample size calculation is done using Stats Direct statistical software version 2.7.2 for microsoft Windows, Stats Direct Ltd., Cheshire, UK.
- Conditions
- Hysteroscopy
- Being tested
- Celecoxib, Tramadol, Placebo 1, Placebo 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Women will receive oral Celecoxib 200mg 2 hours before the procedure
TramadolDrug
Women will receive oral Tramadol 100mg 2 hours before the procedure
Placebo 1Drug
Women will receive an oral placebo similar to Tramadol 2 hours before the procedure
Placebo 2Drug
Women will receive an oral placebo similar to Celecoxib 2 hours before the procedure
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Active comparator | Women will receive oral Celecoxib 200mg 2 hours before the procedure Receives: Drug: Celecoxib |
| Tramadol | Active comparator | Women will receive oral Tramadol 100 mg 2 hours before the procedure Receives: Drug: Tramadol |
| Placebo | Placebo comparator | Women will receive an oral placebo similar to Tramadol and an oral placebo similar to Celecoxib 2 hours before the procedure Receives: Drug: Placebo 1; Drug: Placebo 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception during the procedure
A nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain
Measured: 5 minutes after starting the procedure
Secondary outcomes (1)
Pain perception after the procedure
A nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain
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 posted13 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HysteroscopyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- Investigators
- AbdelGany M Hassan, MRCOG, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736071
- Sponsor's protocol ID
- Hyst 8
- Status last verified
- Jul 2016
- First submitted
- 8 Apr 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hassan A, Wahba A, Haggag H. Tramadol versus Celecoxib for reducing pain associated with outpatient hysteroscopy: a randomized double-blind placebo-controlled trial. Hum Reprod. 2016 Jan;31(1):60-6. doi: 10.1093/humrep/dev291. Epub 2015 Nov 29.
PubMed 26621854Ahmad 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 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy: A Double Blind Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT02736071
- Acronym / sponsor ID
- Hyst 8
- Conditions
- Hysteroscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 13 Apr 2016 (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.
Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.
Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).
Detailed description
Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.
All procedures will be scheduled to be done postmenstrual or after cessation of bleeding in case of metrorrhagia and will be done in the lithotomy position. The procedures will be performed using 30 degree angle 2.7 mm rigid hysteroscope with a 5mm outer diameter continuous flow hysteroscope with a 5 French working channel, a Teknolight 180 XA light source, and a Xenon high density fibre optic light cable 3.5mm, 2300mm Light cable without adaptors and a T Camera teknocam 2000S pro. All the equipment are provided by Tekno GmbH and Co®, Germany.
Vaginoscopic approach will be used for insertion of the hysteroscope in all cases. The hysteroscope will be gently introduced into the uterine cavity after visualization of the cervix and identification of the external os. Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. Patients will also be asked to report any side effects. The main outcome measure will be patients' pain perception during the procedure.
Statistics:
Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using ANOVA test for independent samples while categorical data will be compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.
Sample size calculation:
To the best of researchers knowledge this is the first trial to investigate the role of Celecoxib and oral Tramadol in reducing outpatient operative hysteroscopy associated pain, with no previous data to calculate the sample size with. Data from studies on diagnostic hysteroscopy cannot be applied because operative hysteroscopies need more manipulations and cause more pain. Assuming that the response will be normally distributed, the sample size is calculated to detect a mean difference of 1 unit between Tramadol and Celecoxib pain scores during the procedure (lower difference are not considered clinically relevant) using VAS assuming that the within group standard deviation will be 2. Investigators will need to study 64 cases in each group to be able to reject the null hypothesis that the population means of the Tramadol and Celecoxib are equal with probability (power) 0.8. Investigators added 6 cases to each arm accounting for any missing data and procedure failure ending in 70 cases in each group. The Type I error probability associated with this test of this null hypothesis is 0.05 using Student's t test for independent samples. Sample size calculation is done using Stats Direct statistical software version 2.7.2 for microsoft Windows, Stats Direct Ltd., Cheshire, UK.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Active comparator | Drug: CelecoxibWomen will receive oral Celecoxib 200mg 2 hours before the procedure |
| Tramadol | Active comparator | Drug: TramadolWomen will receive oral Tramadol 100 mg 2 hours before the procedure |
| Placebo | Placebo comparator | Drug: Placebo 1, Drug: Placebo 2Women will receive an oral placebo similar to Tramadol and an oral placebo similar to Celecoxib 2 hours before the procedure |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Indication for operative outpatient hysteroscopy, indications will include endometrial biopsy, polypectomy, septum resection, intra-uterine device removal and adhesiolysis.
Key exclusion criteria (4 listed)
- Submucous myomas.
- Known medical disorders like uncontrolled diabetes, hypertension, cardiac, renal or liver disease.
- Gastritis or peptic ulcer.
- Allergy to Tramadol or Celecoxib.
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 |
|---|---|---|
| CelecoxibWomen will receive oral Celecoxib 200mg 2 hours before the procedure | Drug | Celecoxib |
| TramadolWomen will receive oral Tramadol 100mg 2 hours before the procedure | Drug | Tramadol |
| Placebo 1Women will receive an oral placebo similar to Tramadol 2 hours before the procedure | Drug | Placebo |
| Placebo 2Women will receive an oral placebo similar to Celecoxib 2 hours before the procedure | Drug | Placebo |
Primary outcome
Pain perception during the procedure
Time frame: 5 minutes after starting the procedure
A nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain
1 secondary outcome
Pain perception after the procedure
Time frame: 30 minutes after completing the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Background: PubMed 26621854Hassan A, Wahba A, Haggag H. Tramadol versus Celecoxib for reducing pain associated with outpatient hysteroscopy: a randomized double-blind placebo-controlled trial. Hum Reprod. 2016 Jan;31(1):60-6. doi: 10.1093/humrep/dev291. Epub 2015 Nov 29.
- 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.
- Individual participant dataSharing planned: No
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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 M 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 3 study testing Celecoxib and Tramadol in people with Hysteroscopy, 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 1 inclusion and 4 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 6 Jul 2016. 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 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 perception during the procedure (time frame: 5 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 NCT02736071, which also lists 3 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 Jul 2016.