The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy

NCT03701984 | Completed Phase 4

• 1 other identifier: hysteroscopy
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of Tramadol and intrauterine lidocaine infusion in reducing pain during outpatient diagnostic hysteroscopy in postmenopausal women.

Conditions

Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Pain perception during the procedure

  The pain will be assessed using a visual analogue scale(VAS) after inserting the hysteroscope through the cervical canal.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. The pain VAS is self-completed by the patients. The patients are asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

  10 minutes after starting the procedure.

Secondary Outcomes (1)

• Pain perception after the procedure

  10 minutes after the procedure.

Study Arms (3)

lidocaine infusion arm

EXPERIMENTAL

The lidocaine group will be administered a 1,000 ml distention medium containing 5 ml lidocaine per 250 ml (DEBOCAINE (LIDOCAINE) 2% 1 VIAL 50 ML, Sigma-Tec pharmaceutical Industry. Co. Egypt) and oral placebo similar to tramadol(given 1 hour before the procedure).

Drug: Lidocaine

tramadol arm

ACTIVE COMPARATOR

will be administered with an oral tramadol tablet (Tramal®, Memphis, Giza, Egypt) 1 h before the procedure and with a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml.

Drug: Tramadol

placebo group

PLACEBO COMPARATOR

will be administered with a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).

Drug: placebo

Interventions

Lidocaine DRUG

The lidocaine group will be administered a 1,000 ml distention medium containing 5 ml lidocaine per 250 ml (DEBOCAINE (LIDOCAINE) 2% 1 VIAL 50 ML, Sigma-Tec pharmaceutical Industry. Co. Egypt) and oral placebo similar to tramadol(given 1 hour before the procedure).

Also known as: lidocaine infusion arm

lidocaine infusion arm

Tramadol DRUG

an oral tramadol tablet (Tramal®, Memphis, Giza, Egypt) 1 h before the procedure and with a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml.

Also known as: tramadol HCL arm

tramadol arm

placebo DRUG

a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).

Also known as: placebo arm

placebo group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
• Consent to the procedure

You may not qualify if:

• Positive Chlamydia culture.
• patients who have an Allergy to local anesthesia or tramadol.
• A previous adverse reaction to any of the drugs used in the study.
• Patients were receiving any form of analgesia or current use of monoamine oxidase inhibitors.
• Nulliparous patients and patients with cervical pathology, retroverted uterus (detected by transvaginal ultrasound), and previous cervical surgery.
• Patients who have severe vaginal bleeding.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine Cairo university

Giza, 11231, Egypt

Location

Related Publications (1)

• Samy A, Nabil H, Abdelhakim AM, Mahy ME, Abdel-Latif AA, Metwally AA. Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study. Climacteric. 2020 Aug;23(4):397-403. doi: 10.1080/13697137.2020.1742685. Epub 2020 Apr 17.

  PMID: 32299254 DERIVED

MeSH Terms

Interventions

Lidocaine; Tramadol

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• AHMED S ASHOUR, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: October 15, 2018
• Primary Completion: August 10, 2019
• Study Completion: August 15, 2019
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

EG (1)