Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice (HSG-2010)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Consorci Sanitari de Terrassa.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Consorci Sanitari de Terrassa
Information provided by:
Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier:
NCT01303614
First received: February 24, 2011
Last updated: NA
Last verified: September 2010
History: No changes posted
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Purpose
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysterosalpingography diagnostic practice.
| Condition | Intervention | Phase |
|---|---|---|
|
Gynecological Pathology |
Drug: Lidocaine-Prilocaine cream Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Consorci Sanitari de Terrassa:
Primary Outcome Measures:
- pain reduction in the performance of hysterosalpingography [ Time Frame: after hysterosalpingography and a month later ] [ Designated as safety issue: No ]decrease in pain inmediately after the completion of hysterosalpingography and one month after completion of the diagnostic test by an analogue pain scale.
Secondary Outcome Measures:
- sense of discomfort experience during the procedure [ Time Frame: a month after hysterosalpingography ] [ Designated as safety issue: No ]willingness to repeat the diagnostic technique
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Lidocaine-Prilocaine cream |
Drug: Lidocaine-Prilocaine cream
Implementation of 3 cm of lidocaine-prilocaine in the endocervical canal, 10 minutes before the intervention with a syringe without needle 5ml. Application, with a swab of the anesthetic cream ectocervix level.
Other Name: EMLA
|
|
Placebo Comparator: Placebo
purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid
|
Drug: placebo
3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5 ml syringe without needle. Application, with a swab in gel ectocervix.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients that must perform a hysterosalpingography
- acceptance to participate in the study signed informed consent
Exclusion Criteria:
- hypersensitivity or allergy to anesthetics
- refusal of the patient
- patients under age 18 years old and pregnant
- unbearable pain that involves other analgesic measures
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303614
Contacts
| Contact: Baldomero Arnau Rivera, MD, PhD | 0034 937314138 | barnau@cst.cat |
Locations
| Spain | |
| Consorci Sanitari de Terrassa | Not yet recruiting |
| Terrassa, Barcelona, Spain, 08227 | |
| Contact: Baldomero Arnau Rivera 0034 937314138 barnau@cst.cat | |
| Principal Investigator: Baldomero Arnau Rivera, MD, PhD | |
Sponsors and Collaborators
Consorci Sanitari de Terrassa
Investigators
| Principal Investigator: | Baldomero Arnau Rivera, MD, PhD | Consorci Sanitari de Terrassa |
More Information
No publications provided
| Responsible Party: | Baldomero Arnau Rivera, Consorci Sanitari de Terrassa |
| ClinicalTrials.gov Identifier: | NCT01303614 History of Changes |
| Other Study ID Numbers: | Hysterosalpingography-2010 |
| Study First Received: | February 24, 2011 |
| Last Updated: | February 24, 2011 |
| Health Authority: | SPAIN: Spanish Agency of the drug and medical device |
Keywords provided by Consorci Sanitari de Terrassa:
|
hysterosalpingography prilocaine local anaesthetic pain relief gynecological pathology |
Additional relevant MeSH terms:
|
Anesthetics Prilocaine Lidocaine EMLA Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents Anesthetics, Combined |
ClinicalTrials.gov processed this record on May 22, 2013