Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy

Pain Clinical Trial

Official title:

Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02428777
• Other study ID #: Hyst 5
• Status: Recruiting
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Cairo University
• Contact: AbdelGany M Hassan, MRCOG, MD
• Phone: +201017801604
• Email: abdelgany2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during operative outpatient hysteroscopy. Women undergoing operative hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale

Description:

Hysteroscopic examination is currently the most informative investigation for patients with abnormal uterine bleeding and infertility. Outpatient hysteroscopy involves the use of miniaturized endoscopic equipment to directly visualise the endometrial cavity, without the need of formal theatre facilities, general or regional anaesthesia.

Outpatient hysteroscopy is increasingly being used as a cost-effective alternative to in-patient hysteroscopy under general anaesthesia. Like other outpatient gynaecological procedures, however, it has the potential to cause pain severe enough for the procedure to be abandoned.

Opioid analgesics are widely used for the control of moderate to severe pain. Tramadol hydrochloride, a synthetic opioid is an orally active, clinically effective centrally acting analgesic having a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents.

Diclofenac is a non steroidal anti inflammatory drug which inhibits the cyclooxygenase enzyme.

The study will be conducted in the outpatient hysteroscopy clinic in Cairo university hospitals. All patients attending the outpatient hysteroscopy clinic will be invited to participate in the study. The invitation will include a clear full explanation of the study and patients will provide oral consent. Written informed consent is not needed since the procedure and Patients will be included in the study if they give written consents.

Tramadol, diclofenac and placebo will be enclosed in sealed envelopes which will be numbered using computer generated random table. Neither the patient nor the physician will be aware of the drug used. 210 women will be categorized into 3 groups: Group I who will receive oral Tramadol 100mg (Trama®, Global Napi) orally 1 hour before the procedure, group II who will receive oral diclofenac 100mg (voltaren® 100, Novartis) 1 hour before the procedure, and group III who will receive an oral placebo.

Full history will be taken followed by general and local examination. The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be set at 100mm Hg.

The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 5Charr provided by Tecchno medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors provided by Tecchno medical GmbH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Indication for operative outpatient hysteroscopy like endometrial biopsy, endometrial polyp, uterine septum, intrauterine adhesions, and loop retrieval.

Exclusion Criteria:

• Known allergy to tramadol or diclofenac.

• Diabetes, hypertension, gastritis, peptic ulcer, cardiac, renal or liver disease.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Tramadol
Women will receive oral tramadol 100 mg 1 hour before the procedure.
• Diclofenac
Women will receive oral diclofenac 100 mg 1 hour before the procedure
• Placebo
Women will receive an oral placebo 1 hour before the procedure

Locations

Country	Name	City	State
Egypt	BeniSuef University hospitals	BeniSuef
Egypt	Cairo university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during the procedure as measured by the visual analogue scale	Women will be asked to score their pain using a visual analogue scale	5 minutes after starting the procedure
Primary	Pain after the procedure as measured by the visual analogue scale	Women will be asked to score their pain using a visual analogue scale	30 minutes after completing the procedure