Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

IUD Insertion Clinical Trial

— SALUD  

Official title:

Self-Administered Lidocaine Gel for Pain Management With IUD Insertion: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738203
• Other study ID #: 32825
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2016
• Est. completion date: October 19, 2017

Study information

• Verified date: June 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 19, 2017
• Est. primary completion date: October 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.

Exclusion Criteria:

Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.

Related Conditions & MeSH terms

• IUD Insertion

Intervention

Drug:
• Vaginal 2% Lidocaine
Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
• Surgical Lubricant Jelly
Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly

Locations

Country	Name	City	State
United States	Stanford Gynecology Clinic	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion	Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.	0-3 minutes after procedure completed
Secondary	Anticipated Pain as Measured by a Visual Analog Scale	Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.	30 Minutes prior to procedure
Secondary	Baseline Pain as Measured by a Visual Analog Scale	Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.	Immediately prior to procedure; upon arrival to procedure room
Secondary	Pain After Speculum Placement as Measured by a Visual Analog Scale	Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.	Intraoperative
Secondary	Pain After Tenaculum Placement as Measured by a Visual Analog Scale	Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.	Intraoperative