Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women

NCT ID: NCT02736019

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30

Brief Summary

Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the investigators will use the double dummy technique in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a placebo similar to Celecoxib. All drugs will be given 2 hours 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 twenty five women with post menopausal bleeding will be randomly divided into three equal groups. To ensure blinding the investigators will use the double dummy technique in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

The procedure will be done in the lithotomy position. The investigators will use a 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 (no use of speculum or tenaculum). The hysteroscope will be gently introduced into the uterine cavity after visualization of the cervix and identification of the external os. The investigators will use saline as the distension medium and the maximum pressure will be set at 80mm Hg. The uterine cavity and tubal ostia will be systematically visualized. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 5Charr provided by Tekno GmbH and Co®. The most suspicious area will be identified, the forceps will be advanced and opened against the suspicious area and the tissue will be grasped, rotated 90 degrees and removed with the hysteroscope out of the cervical canal 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 and the secondary outcome will be the adequacy of the sample.

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 the investigators' knowledge this is the first trial to investigate the role of Celecoxib and oral Tramadol in reducing outpatient hysteroscopy associated pain in post menopausal women, with no previous data to calculate the sample size with in this cohort of women. Data from studies on premenopausal women cannot be applied to post menopausal women because hysteroscopies in post menopausal women are usually more difficult, require more cervical 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 and assuming that the within group standard deviation will be 2. The 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. The investigators added 11 cases to each arm accounting for any missing data and procedure failure ending in 75 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 MS Windows, Stats Direct Ltd., Cheshire, UK.

Conditions

Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Celecoxib

Women will receive oral celecoxib 200mg 2 hours before the procedure

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: DRUG

Women will receive oral Celecoxib 200mg 2 hours before the procedure

Placebo 1

Intervention Type: DRUG

Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.

Tramadol

Women will receive oral Tramadol 100mg 2 hours before the procedure

Group Type: ACTIVE_COMPARATOR

Tramadol

Intervention Type: DRUG

Women will receive oral Tramadol 100 mg 2 hours before the procedure

Placebo 2

Intervention Type: DRUG

Women will receive an oral placebo similar to celecoxib 2 hours before the procedure

Placebo

Women will receive a placebo similar to celecoxib and a placebo similar to Tramadol

Group Type: PLACEBO_COMPARATOR

Placebo 1

Intervention Type: DRUG

Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.

Placebo 2

Intervention Type: DRUG

Women will receive an oral placebo similar to celecoxib 2 hours before the procedure

Interventions

Celecoxib

Women will receive oral Celecoxib 200mg 2 hours before the procedure

Intervention Type: DRUG

Tramadol

Women will receive oral Tramadol 100 mg 2 hours before the procedure

Intervention Type: DRUG

Placebo 1

Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.

Intervention Type: DRUG

Placebo 2

Women will receive an oral placebo similar to celecoxib 2 hours before the procedure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Post menopausal women.
• vaginal bleeding.
• Endometrial thickness >4mm.

Exclusion Criteria

• Medical disorders like uncontrolled diabetes or hypertension, cardiac, renal , liver disease.
• Gastritis or peptic ulcer.
• Allergy to Tramadol or Celecoxib.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

AbdelGany Hassan

Lecturer of Gynecology and Obstetrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AbdelGany M Hassan

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

AbdelGany M Hassan, MRCOG, MD

Role: CONTACT

abdelgany2@gmail.com

+201017801604

Facility Contacts

AbdelGany MA Hassan, MRCOG, MD

Role: primary

abdelgany2@gmail.com

00217801604

References

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.

Reference Type: BACKGROUND

PMID: 26621854 (View on PubMed)

Ahmad 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.

Reference Type: BACKGROUND

PMID: 21255900 (View on PubMed)

van 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.

Reference Type: BACKGROUND

PMID: 17516956 (View on PubMed)

Other Identifiers

Hyst 7

Identifier Type: -

Identifier Source: org_study_id