PainNCT05911126
How to Reduce Pain in Patients Undergoing Office Hysteroscopy.
A study of Pain, run by Cairo University.
Trial summary
The aim of this study is to compare the effectiveness and the side effects of hyosine-N- butylbromide (HBB) \& Celecoxib administered alone versus in combination reducing pain associated with outpatient hysteroscopy in married female patients aged 18-40 attending the outpatient hysteroscopy clinic of Kasr Al Ainy… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2023to 13 Dec 2023
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi, septae)
- Reproductive age 20 - 40yrs.
- Postmenstrual days from D-6 to D-11 of the cycle (except in irregular bleeding)
Who cannot join
- Menopausal and amenorrheic patients
- Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy
- Previous cervical surgery eg; cauterization and conization
- Patients whose vaginoscopic approach will not be enough and where a tenaculum will be used.
- Patients with peptic ulcers or other contraindications to HBB or celecoxib.
- Patients who will have an office operative procedure will be excluded.
- Patients who will refuse or ask to be excluded from the study after enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Double Blinded Placebo-controlled Trial to Compare the Effect of Hyoscine-N-butyl Bromide (HBB) or Celecoxib Administered Alone Versus in Combination to Reduce Pain in Patients Undergoing Office Hysteroscopy.
The aim of this study is to compare the effectiveness and the side effects of hyosine-N- butylbromide (HBB) \& Celecoxib administered alone versus in combination reducing pain associated with outpatient hysteroscopy in married female patients aged 18-40 attending the outpatient hysteroscopy clinic of Kasr Al Ainy, Cairo University Hospital.
Read the detailed description
This study will be a prospective single centre study that shall include 180 women aged 18-40 years from the outpatient hysteroscopy clinic, Kasr Al Ainy Cairo University Hospitals. After a self-introduction, each patient will be explained thoroughly about what the study is all about and its objective. All patients will be subjected to history taking (specially to rule out an contraindications of HBB \& Celecoxib), pelvic examination and TVUS.
We will make sure that each of the patients voluntarily agrees to participate in this study for this, we will request each patient to sign a written consent form. She will be told that she can withdraw from the study any time.
Patient will be randomized into 3 groups using 1:1:1 allocation ratio. An independent person will generate the allocation sequence using computer- generated random numbers. Allocation will be concealed using sequentially numbered (1-180) opaque sealed envelopes kept with the attending nurse and enclosing a paper denoting group A, B or C. The sealed envelopes will be kept with the attending nurse.
After the patients signs their written consent, the nurse will pick a random number from the available allocation sequence and will open the envelop to detect to which allocated group the patient should be allocated to without showing it to the patient or the observer. The drugs will be stored in the outpatient clinic pharmacy under tags A, B or C and the patient will be given the drug with a glass of water. Neither the patient nor the physician will be aware of the drug used. All patients will receive the enclosed medication 1 hour before procedure.
We will divide the patients into three groups according to the medication will receive.
Group A (60 participants) will receive two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim) and one capsule of Celecoxib 200 mg (Celebrex 200, Pfizer, USA) simultaneously.
Group B (60 participants) will receive one oral placebo capsule similar in size, structure, and color to celecoxib and two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim)
Group C (60 participants) will receive two oral placebo tablets similar in size and color to Buscopan tablet and one capsule of Celecoxib 200 mg (Celebrex ® 200, Pfizer, USA).
The placebo tablets will be manufactured in the faculty of pharmacy - Cairo University.
The procedure will be done in the lithotomy position with a 30°angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath [Karl Storz, Germany]. Vaginoscopic approach will be used for insertion of the hysteroscope in all cases (no use of speculum or tenaculum). All the procedures will be done by the same operator using the same equipment. Natural saline will be used as the distension media for all the patients and the pressure of the will be set at 60 mmHg.
The woman's perception of pain will be assessed for each group on three occasions:
- During the procedure (after the hysteroscope will be introduced in the uterine cavity).
- Immediately after the procedure when the hysteroscope will be withdrawn from the uterus.
- 30 minutes after the completion of the procedure.
Pain will be assessed with the use of a 10 visual analogue scale (VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible pain. To assess the pain during the procedure, the attending nurse will reexplain the scale to the patient and will had the her the VAS ruler. The patient will be asked to mark the point she will think will be corresponding to her pain on the ruler at the specific times mentioned above.
Women will also be asked to report any side effect and will be asked about the general acceptability of the procedure whether it was acceptable, difficult, or inacceptable.
The total procedure time will be recorded in seconds and the ease of procedure (easy or difficult) will be recorded by the operator.
- Conditions
- Pain
- Being tested
- Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tabletDrug
Also called (Celebrex ® 200, Pfizer, USA), (Buscopan 10 mg, Boehringer Ingelheim)
Tablet form received prior to the procedure
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | (60 participants) will receive two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim) and one capsule of Celecoxib 200 mg (Celebrex 200, Pfizer, USA) simultaneously. Receives: Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet |
| Group B | Active comparator | (60 participants) will receive one oral placebo capsule similar in size, structure, and color to celecoxib and two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim) Receives: Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet |
| Group C | Active comparator | (60 participants) will receive two oral placebo tablets similar in size and color to Buscopan tablet and one capsule of Celecoxib 200 mg (Celebrex ® 200, Pfizer, USA). Receives: Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during whole procedure
The pain sensation during the procedure. The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).
Measured: 1 hour
Secondary outcomes (1)
Post procedural pain
Immediate pain and post 30-mins pain after the completion of the procedure.
- Side effects such as nausea, vomiting and epigastric pain.
- Procedure time and ease of entry as reported by the operator.
- Overall acceptability of the procedure by the patient.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start13 Jun 2023 (estimated)
- Primary completion13 Oct 2023 (estimated)
- Study completion13 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated in 3 groups, first group receiving 2 medications, second group receiving 1 medication and placebo and a third group receiving 1 medication placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senderila Abdulkareem, Cairo University
- Investigators
- Eman A Hussein, MD, Study chair, Cairo UniversityNihal M El-Demiry, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911126
- Sponsor's protocol ID
- MD-308-2022
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 20 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Placebo-controlled Trial to Compare the Effect of Hyoscine-N-butyl Bromide (HBB) or Celecoxib Administered Alone Versus in Combination to Reduce Pain in Patients Undergoing Office Hysteroscopy.
- ClinicalTrials.gov ID
- NCT05911126
- Acronym / sponsor ID
- MD-308-2022
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Jun 2023 (estimated)
- Primary completion
- 13 Oct 2023 (estimated)
- Study completion
- 13 Dec 2023 (estimated)
- First posted
- 20 Jun 2023 (actual)
- 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 aim of this study is to compare the effectiveness and the side effects of hyosine-N- butylbromide (HBB) \& Celecoxib administered alone versus in combination reducing pain associated with outpatient hysteroscopy in married female patients aged 18-40 attending the outpatient hysteroscopy clinic of Kasr Al Ainy, Cairo University Hospital.
Detailed description
This study will be a prospective single centre study that shall include 180 women aged 18-40 years from the outpatient hysteroscopy clinic, Kasr Al Ainy Cairo University Hospitals. After a self-introduction, each patient will be explained thoroughly about what the study is all about and its objective. All patients will be subjected to history taking (specially to rule out an contraindications of HBB \& Celecoxib), pelvic examination and TVUS.
We will make sure that each of the patients voluntarily agrees to participate in this study for this, we will request each patient to sign a written consent form. She will be told that she can withdraw from the study any time.
Patient will be randomized into 3 groups using 1:1:1 allocation ratio. An independent person will generate the allocation sequence using computer- generated random numbers. Allocation will be concealed using sequentially numbered (1-180) opaque sealed envelopes kept with the attending nurse and enclosing a paper denoting group A, B or C. The sealed envelopes will be kept with the attending nurse.
After the patients signs their written consent, the nurse will pick a random number from the available allocation sequence and will open the envelop to detect to which allocated group the patient should be allocated to without showing it to the patient or the observer. The drugs will be stored in the outpatient clinic pharmacy under tags A, B or C and the patient will be given the drug with a glass of water. Neither the patient nor the physician will be aware of the drug used. All patients will receive the enclosed medication 1 hour before procedure.
We will divide the patients into three groups according to the medication will receive.
Group A (60 participants) will receive two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim) and one capsule of Celecoxib 200 mg (Celebrex 200, Pfizer, USA) simultaneously.
Group B (60 participants) will receive one oral placebo capsule similar in size, structure, and color to celecoxib and two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim)
Group C (60 participants) will receive two oral placebo tablets similar in size and color to Buscopan tablet and one capsule of Celecoxib 200 mg (Celebrex ® 200, Pfizer, USA).
The placebo tablets will be manufactured in the faculty of pharmacy - Cairo University.
The procedure will be done in the lithotomy position with a 30°angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath [Karl Storz, Germany]. Vaginoscopic approach will be used for insertion of the hysteroscope in all cases (no use of speculum or tenaculum). All the procedures will be done by the same operator using the same equipment. Natural saline will be used as the distension media for all the patients and the pressure of the will be set at 60 mmHg.
The woman's perception of pain will be assessed for each group on three occasions:
- During the procedure (after the hysteroscope will be introduced in the uterine cavity).
- Immediately after the procedure when the hysteroscope will be withdrawn from the uterus.
- 30 minutes after the completion of the procedure.
Pain will be assessed with the use of a 10 visual analogue scale (VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible pain. To assess the pain during the procedure, the attending nurse will reexplain the scale to the patient and will had the her the VAS ruler. The patient will be asked to mark the point she will think will be corresponding to her pain on the ruler at the specific times mentioned above.
Women will also be asked to report any side effect and will be asked about the general acceptability of the procedure whether it was acceptable, difficult, or inacceptable.
The total procedure time will be recorded in seconds and the ease of procedure (easy or difficult) will be recorded by the operator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Participants will be allocated in 3 groups, first group receiving 2 medications, second group receiving 1 medication and placebo and a third group receiving 1 medication placebo
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet(60 participants) will receive two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim) and one capsule of Celecoxib 200 mg (Celebrex 200, Pfizer, USA) simultaneously. |
| Group B | Active comparator | Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet(60 participants) will receive one oral placebo capsule similar in size, structure, and color to celecoxib and two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim) |
| Group C | Active comparator | Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet(60 participants) will receive two oral placebo tablets similar in size and color to Buscopan tablet and one capsule of Celecoxib 200 mg (Celebrex ® 200, Pfizer, USA). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi, septae)
- Reproductive age 20 - 40yrs.
- Postmenstrual days from D-6 to D-11 of the cycle (except in irregular bleeding)
Key exclusion criteria (7 listed)
- Menopausal and amenorrheic patients
- Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy
- Previous cervical surgery eg; cauterization and conization
- Patients whose vaginoscopic approach will not be enough and where a tenaculum will be used.
- Patients with peptic ulcers or other contraindications to HBB 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 |
|---|---|---|
| Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tabletAlso: (Celebrex ® 200, Pfizer, USA), (Buscopan 10 mg, Boehringer Ingelheim)Tablet form received prior to the procedure | Drug | Group A, Group B, Group C |
Primary outcome
Pain during whole procedure
Time frame: 1 hour
The pain sensation during the procedure. The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).
1 secondary outcome
Post procedural pain
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2023.
- 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.
Eman A Hussein, MD study chair
Cairo University
Nihal M El-Demiry, MD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study of Pain, run by Cairo University.
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 3 inclusion and 7 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 20 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Senderila A Mutlag, MSc (00201099688937, senderila.abdulkareem42687@postgrad.kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during whole procedure (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2023.