Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography

Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography: a Randomized Controlled Trial

our aims to investigate the effectiveness of10% Lidocaine Spray plus oral celecoxib for Pain Control During Hysterosalpingography

Study Overview

• Status: Completed
• Conditions: IUCD Complication
• Intervention / Treatment: Drug: celecoxib plus lidocaine; Drug: Celecoxib; Drug: lidocaine

Detailed Description

hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• any patient came for Hysterosalpingography

Exclusion Criteria:

• any patient has contraindication to Hysterosalpingography

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Celecoxib plus lidocaine; Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure	Drug: celecoxib plus lidocaine; Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure; Other Names: experimental
Active Comparator: Celecoxib; Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure	Drug: Celecoxib; Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure; Other Names: Active Comparator
Active Comparator: lidocaine; placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure	Drug: lidocaine; placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure; Other Names: Active Comparato

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean pain score during the procedure	Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores	10 minuets

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cyclooxygenase 2 Inhibitors; Lidocaine; Celecoxib
• Other Study ID Numbers: aswu/351/5/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No