The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement

Pain Clinical Trial

Official title:

Double Blind, Randomized, Prospective Trial of Impact of Pain Scores on Intrauterine Lidocaine vs Normal Saline Infusion Before IUD Placement.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311102
• Other study ID #: 13531-01
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2010
• Last updated: December 17, 2013
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Women's Health Care Clinic, Torrance, California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will reduce pain scores related to that procedure. In a double blinded randomized trial of 60 women receiving either normal saline or lidocaine infused through an endometrial aspirator, pain scores will be obtained for each step of the IUD placement procedure and for the total experience.

Description:

IUDs are the most frequently used method of reversible birth control. The placement procedure is straightforward, but can cause the women cramping and pain. Every woman is advised to take Ibuprofen or acetaminophen prior to her appointment. Gentle techniques and distraction are used to minimize discomfort. However, some women still have measurable pain during and immediately after the procedure.

Investigators have shown that infusion of 5cc of a 2% concentration of liquid lidocaine into the inside of the uterus can reduce the pain that is associated with other procedures, such as biopsies done of the lining of the uterus. The investigators seek to determine if a similar infusion made before IUD placement may reduce pain. Because pain is a subjective complaint and because plastic tubing is being used to sound the uterus instead of the usual metal probe (a uterine sound), the investigators have included a placebo arm with saline infusion. All women will receive oral medication in advance of IUD placement, so no woman will be subject to placebo only.

Those women undergoing routine screening for IUD candidacy will be approached. Medical and social history and routine laboratory testing are to be done. The risks, benefits, and side effects of IUD placement will be explained. They will sign consent forms for the IUD from both the manufacturer and the clinic before evaluation for possible inclusion in this study. Informed consent for the study will be obtained either at that visit or on the day of the IUD placement. All the routine IUD placement steps will be done and she will rate the pain score. A standardized pain scale from 1-10, with 10 being the worst pain in the patient's lifetime, will be used here and at every point in the study. Depth of the uterus will be determined by introducing a plastic tubing into the woman's uterus. This tubing will either be filled with 1.3cc of normal saline or 2% lidocaine. The liquid will be infused at certain points within the cervix and uterus. She will again be asked to rate her pain score for that procedure. The tubing will be removed and the IUD will be placed. After the IUD is in the correct position, but before removal of the tenaculum, she will again be asked to rate her pain score for that procedure. After the IUD placement procedure is complete and the patient is dressed, she will be asked to assign an overall pain score. Pain scores between placebo and study drug used will be compared (mean, median and range). Fisher T tests will be performed to determine statistical significance with the p< 0.05 as a cutoff. Sub-analysis will be done comparing scores of which women who have never been pregnant to those who have. If possible, comparisons of pain scores will be made for women who have had vaginal deliveries compared to those who delivered by C-section. The risks to the patient for this study intervention are minimal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women eligible for IUD insertion

• Willing to give consent

Exclusion Criteria:

• Allergy to lidocaine

• Contraindications to IUD use

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine
1.33 cc 2% liquid lidocaine
• Normal Saline
1.33cc normal saline

Locations

Country	Name	City	State
United States	Women's Health Care Clinic	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Women's Health Care Clinic, Torrance, California

Country where clinical trial is conducted

United States, 

References & Publications (11)

Costello MF, Horrowitz S, Steigrad S, Saif N, Bennett M, Ekangaki A. Transcervical intrauterine topical local anesthetic at hysterosalpingography: a prospective, randomized, double-blind, placebo-controlled trial. Fertil Steril. 2002 Nov;78(5):1116-22. — View Citation

Dogan E, Celiloglu M, Sarihan E, Demir A. Anesthetic effect of intrauterine lidocaine plus naproxen sodium in endometrial biopsy. Obstet Gynecol. 2004 Feb;103(2):347-51. — View Citation

Edelman A, Nichols MD, Leclair C, Astley S, Shy K, Jensen JT. Intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2004 Jun;103(6):1267-72. — View Citation

Edelman A, Nichols MD, Leclair C, Jensen JT. Four percent intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2006 Feb;107(2 Pt 1):269-75. — View Citation

Frishman GN, Spencer PK, Weitzen S, Plosker S, Shafi F. The use of intrauterine lidocaine to minimize pain during hysterosalpingography: a randomized trial. Obstet Gynecol. 2004 Jun;103(6):1261-6. — View Citation

Guney M, Oral B, Bayhan G, Mungan T. Intrauterine lidocaine infusion for pain relief during saline solution infusion sonohysterography: a randomized, controlled trial. J Minim Invasive Gynecol. 2007 May-Jun;14(3):304-10. — View Citation

Güney M, Oral B, Mungan T. Efficacy of intrauterine lidocaine for removal of a "lost" intrauterine device: a randomized, controlled trial. Obstet Gynecol. 2006 Jul;108(1):119-23. — View Citation

Gupta N, Ghosh B, Mittal S. Comparison of oral naproxen and intrauterine lignocaine instillation for pain relief during hysterosalpingography. Int J Gynaecol Obstet. 2008 Sep;102(3):284-6. doi: 10.1016/j.ijgo.2008.04.013. Epub 2008 Jul 7. — View Citation

Hui SK, Lee L, Ong C, Yu V, Ho LC. Intrauterine lignocaine as an anaesthetic during endometrial sampling: a randomised double-blind controlled trial. BJOG. 2006 Jan;113(1):53-7. — View Citation

Lau WC, Tam WH, Lo WK, Yuen PM. A randomised double-blind placebo-controlled trial of transcervical intrauterine local anaesthesia in outpatient hysteroscopy. BJOG. 2000 May;107(5):610-3. — View Citation

Trolice MP, Fishburne C Jr, McGrady S. Anesthetic efficacy of intrauterine lidocaine for endometrial biopsy: a randomized double-masked trial. Obstet Gynecol. 2000 Mar;95(3):345-7. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores During Overall IUD Placement	Pain score on 0-9 scale obtained just before the patient left the examination room; with 0 being "no pain" and 9 being "worst pain in life."	Before patient left the examination room at conclusion of procedure	No
Primary	Pain During Tenaculum Placement	Pain score on 0-9 scale for tenaculum placement (without anesthesia); with 0 being "no pain" and 9 being "worst pain in life." Taken to adjust for different pain thresholds among subjects	Immediately following tenaculum placement	No
Primary	Pain Measurement During Liquid Infusion/Sounding	After liquid infused into three parts of the endometrial cavity: in the lower one third, the middle, and at the top of the cavity. Pain was scored on a 0-9 scale; with 0 being "no pain" and 9 being "worst pain in life."	Recorded at the end of the infusion	No
Primary	Pain During IUD Placement	IUD was inserted following the manufacturer's instructions, and a pain score was immediately obtained. Pain was scored on 0-9 scale; with 0 being "no pain" and 9 being "worst pain in life."	Immediately after IUD placement	No