Lidocaine In-situ Gel Before Intrauterine Device Insertion

Assiut University

Status and phase: Completed; Phase 3

Conditions: Pain Relief

Treatments: Drug: placebo in-situ gel; Drug: lidocaine in-situ gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02943135

LISID

Details and patient eligibility

About

Intrauterine device 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 insertion tube, and removing the tube; and placement of the device in the uterus.

Enrollment: 120 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women not taken analgesics or anxiolytics in the 24 hours prior insertion
• Women not taken misoprostol prior to insertion
• No contraindication to or history of allergic reaction to lidocaine
• Women who will accept to participate in the study

Exclusion criteria

• Lidocaine allergy
• Any contraindication to device placement

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

lidocaine in-situ

Active Comparator group

Description:

Self-administered gel 10 min before intrauterine device insertion

Treatment:

Drug: lidocaine in-situ gel

placebo

Placebo Comparator group

Description:

Self-administered gel 10 min before intrauterine device insertion

Treatment:

Drug: placebo in-situ gel