Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diclofenac Potassium With Lidocaine Cream in Reducing Pain During HSG (DP-L)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02709590
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:
The aim of our study is to determine the efficacy of oral diclofenac potassium combined with lidocaine cream on the pain scores during HSG.

Condition or disease Intervention/treatment Phase
Pain Relief With HSG Drug: diclofenac potassium + lidocaine Drug: placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Oral Diclofenac Potassium With Cervical Lidocaine Cream in Reducing Pain During HSG
Study Start Date : March 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: Group A
oral diclofenac potassium plus lidocaine anesthetic cream placed into their cervix immediately before HSG
Drug: diclofenac potassium + lidocaine
patients will have of oral diclofenac potassium 60 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before HSG
Other Name: combined therapy

Placebo Comparator: Group B
oral placebo tablets plus placebo cream placed into their cervix immediately before HSG
Drug: placebo
patients will have of oral placebo tablet 60 minutes before the procedure plus placebo cream placed into their cervix immediately before HSG




Primary Outcome Measures :
  1. Mean pain score during hysterosalpigography by visual analog scale [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. Mean pain score after hysterosalpigography [ Time Frame: 30 minutes ]
  2. side effects of medication [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient came for HSG

Exclusion Criteria:

  • any patient has contraindication to HSG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709590


Locations
Layout table for location information
Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University

Layout table for additonal information
Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02709590     History of Changes
Other Study ID Numbers: HS3
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diclofenac
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors