Pain Control for Intrauterine Device Placement Using Paracervical Block

University of California San Diego

Status: Completed

Conditions: Pain Due to Intrauterine Contraceptive Device

Treatments: Procedure: No Paracervical Block (Sham PCB); Procedure: Paracervical Block (PCB)

Study type: Interventional

Funder types: Other

Identifiers

NCT02219308

141025

Details and patient eligibility

About

Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs. Paracervical block pain may decrease this placement pain.

Full description

Modern IUDs are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy. Fear of IUD placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block (PCB) compared to PCB alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement. Studies to evaluate effectiveness of ibuprofen and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous. There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed.

Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous women. Therefore the primary aim of this study is to determine whether a paracervical block (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD placement when compared to no paracervical block.

Enrollment: 67 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nulliparous women
• English or Spanish speaking
• Present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).

Exclusion criteria

• Pregnancy
• Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
• If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
• Misoprostol administration within 24 hours of enrollment
• History of prior IUD insertion
• Known contraindications to IUD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Paracervical Block (PCB)

Experimental group

Description:

Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed. Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.

Treatment:

Procedure: Paracervical Block (PCB)

No Paracervical Block (Sham PCB)

Sham Comparator group

Description:

Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed. Subject then receives Sham paracervical block with capped needle. Provider then places IUD.

Treatment:

Procedure: No Paracervical Block (Sham PCB)