Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Control for Intrauterine Device Placement Using Paracervical Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219308
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sheila Mody, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Due to Intrauterine Contraceptive Device Procedure: Paracervical Block (PCB) Procedure: No Paracervical Block (Sham PCB) Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pain Control for Intrauterine Device Placement: A Randomized Controlled Trial of Paracervical Block
Actual Study Start Date : October 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: Paracervical Block (PCB)

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.

Procedure: Paracervical Block (PCB)

Drug: 1% Lidocaine Hydrochloride

Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.

IUD placement then proceeds


Sham Comparator: No Paracervical Block (Sham PCB)

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.

Procedure: No Paracervical Block (Sham PCB)

Drug: 1% Lidocaine Hydrochloride

Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.

IUD placement then proceeds





Primary Outcome Measures :
  1. Pain With Intrauterine Device (IUD) Placement [ Time Frame: Moment of IUD insertion ]
    Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.


Secondary Outcome Measures :
  1. Median Pain Scores for All Time Points [ Time Frame: Anticipation of procedure through 5 minutes after IUD placement ]
    Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219308


Locations
Layout table for location information
United States, California
UCSD
San Diego, California, United States, 92103
Planned Parenthood Mission Bay Parker Center
San Diego, California, United States, 92109
Sponsors and Collaborators
University of California, San Diego
Investigators
Layout table for investigator information
Principal Investigator: Sheila Mody, MD MPH UCSD
  Study Documents (Full-Text)

Documents provided by Sheila Mody, University of California, San Diego:
Publications:
Maguire et al. "Intracervical lidocaine gel for IUD insertion: a randomized control trial." Contraception. January 2012.
Roche, NE et al. "The effect of peri-operative ketorolac on pain control in pregnancy termination." Contraception. Article in Press, October 2011
Zieman, Mimi et al. A Pocket Guide to Managing Contraception. The Bridging Gap Foundation. © 2010

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sheila Mody, Women's Reproductive Health Research (K12) Scholar, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02219308    
Other Study ID Numbers: 141025
First Posted: August 18, 2014    Key Record Dates
Results First Posted: November 1, 2019
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheila Mody, University of California, San Diego:
Contraception
Pain
Intrauterine Device
Paracervical Block