The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy
NCT ID: NCT03701984
Last Updated: 2019-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
156 participants
INTERVENTIONAL
2018-10-15
2019-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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lidocaine infusion arm
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).
Lidocaine
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).
tramadol arm
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.
Tramadol
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.
placebo group
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).
placebo
a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).
Interventions
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Lidocaine
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).
Tramadol
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.
placebo
a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Consent to the procedure
Exclusion Criteria
* 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.
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Principal Investigators
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AHMED S ASHOUR, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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faculty of medicine Cairo university
Giza, , Egypt
Countries
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References
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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.
Other Identifiers
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hysteroscopy
Identifier Type: -
Identifier Source: org_study_id
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