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PainNCT05911126

How to Reduce Pain in Patients Undergoing Office Hysteroscopy.

A study of Pain, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 groups in NCT05911126
Study groupRoleWhat they receive
Group AActive 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 BActive 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 CActive 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.

  1. 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)
  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.

  1. First posted20 Jun 2023
  2. Study start13 Jun 2023 (estimated)
  3. Primary completion13 Oct 2023 (estimated)
  4. Study completion13 Dec 2023 (estimated)

Resources

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)
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

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.

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