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

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ClinicalTrials.gov Identifier: NCT03701984
Recruitment Status : Completed
First Posted : October 10, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Samy aly ashour, Cairo University

Tracking Information
First Submitted Date  ICMJE October 8, 2018
First Posted Date  ICMJE October 10, 2018
Last Update Posted Date November 18, 2019
Actual Study Start Date  ICMJE October 15, 2018
Actual Primary Completion Date August 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2019)
Pain perception during the procedure [ Time Frame: 10 minutes after starting 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Pain perception during the procedure [ Time Frame: 10 minutes after starting the procedure. ]
Pain will be assessed using a visual analog scale(VAS) 10 minutes after inserting the hysteroscope.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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2019)
Pain perception after the procedure [ Time Frame: 10 minutes after the procedure. ]
Pain will be assessed using a visual analog scale(VAS) 10 minutes after the procedure. VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. The pain VAS is self-completed by the patient. The patients are asked to place a line perpendicular to the VAS line at the point that represents their pain intensity
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Pain perception after the procedure [ Time Frame: 15 minutes after the procedure. ]
Pain will be assessed using a visual analog scale(VAS) 15 minutes after the procedure. VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. The pain VAS is self-completed by the patient. The patients are asked to place a line perpendicular to the VAS line at the point that represents their pain intensity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy
Official Title  ICMJE The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy in Postmenopausal Women: Randomized Double-Blind Controlled Study
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.
Detailed Description 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. Postmenopausal Women undergoing outpatient hysteroscopy in Cairo university will be divided into three groups, the first group will receive Tramadol 5mg 1 hour before the procedure, the second group will receive 20 ml lidocaine in 1000 ml normal saline infusion during the procedure, and the third will receive a placebo. A visual analog scale will assess pain.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Hysteroscopy
Intervention  ICMJE
  • Drug: 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).
    Other Name: lidocaine infusion arm
  • Drug: 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.
    Other Name: tramadol HCL arm
  • Drug: placebo
    a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).
    Other Name: placebo arm
Study Arms  ICMJE
  • Experimental: 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).
    Intervention: Drug: Lidocaine
  • Active Comparator: 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.
    Intervention: Drug: Tramadol
  • Placebo Comparator: 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).
    Intervention: Drug: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2019)
156
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
150
Actual Study Completion Date  ICMJE August 15, 2019
Actual Primary Completion Date August 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03701984
Other Study ID Numbers  ICMJE hysteroscopy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ahmed Samy aly ashour, Cairo University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cairo University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: AHMED S ASHOUR, MD Cairo University
PRS Account Cairo University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP