How to Reduce Pain in Patients Undergoing Office Hysteroscopy.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Senderila A Mutlag, MSc; Phone Number: 00201099688937; Email: senderila.abdulkareem42687@postgrad.kasralainy.edu.eg
• Study Contact Backup: Name: Hisham M Haggag, MD; Phone Number: 00201224460134; Email: Hmhaggag@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet; Tablet form received prior to the procedure; Other Names: (Celebrex ® 200, Pfizer, USA), (Buscopan 10 mg, Boehringer Ingelheim)
Active Comparator: 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)	Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet; Tablet form received prior to the procedure; Other Names: (Celebrex ® 200, Pfizer, USA), (Buscopan 10 mg, Boehringer Ingelheim)
Active Comparator: 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).	Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet; Tablet form received prior to the procedure; Other Names: (Celebrex ® 200, Pfizer, USA), (Buscopan 10 mg, Boehringer Ingelheim)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Eman A Hussein, MD, Cairo University; Study Director: Nihal M El-Demiry, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 13, 2023
• Primary Completion (Estimated): October 13, 2023
• Study Completion (Estimated): December 13, 2023

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Actual): June 20, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Anticonvulsants; Cyclooxygenase 2 Inhibitors; Mydriatics; Celecoxib; Bromides; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: MD-308-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No