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

NCT01311102 | Completed Phase 4 Results

• 1 other identifier: 13531-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Pain score; IUD placement

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

2% Lidocaine liquid

EXPERIMENTAL

1.33cc of 2% liquid lidocaine infused in endo cervix and endometrium

Drug: Lidocaine

Normal Saline

PLACEBO COMPARATOR

1.33cc of normal saline infused in endo cervix and endometrium

Drug: Normal Saline

Interventions

Lidocaine DRUG

1.33 cc 2% liquid lidocaine

Also known as: Lidocaine Hydrochloride, Xylocaine

2% Lidocaine liquid

Normal Saline DRUG

1.33cc normal saline

Also known as: Sodium chloride

Normal Saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women eligible for IUD insertion
• Willing to give consent

You may not qualify if:

• Allergy to lidocaine
• Contraindications to IUD use

Sponsors & Collaborators

• Women's Health Care Clinic, Torrance, California: lead

Study Sites (1)

Women's Health Care Clinic

Torrance, California, 90502, United States

Location

Related Publications (12)

• 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. doi: 10.1097/01.AOG.0000109519.74229.30.

  PMID: 14754707 BACKGROUND

• 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. doi: 10.1016/s0029-7844(99)00557-8.

  PMID: 10711541 BACKGROUND

• 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.

  PMID: 18603250 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2000.tb13301.x.

  PMID: 10826574 BACKGROUND

• 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. doi: 10.1016/j.jmig.2007.02.007.

  PMID: 17478360 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000194204.71925.4a.

  PMID: 16449111 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2005.00812.x.

  PMID: 16398772 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000127981.53911.0e.

  PMID: 15172863 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000127370.66704.f5.

  PMID: 15172862 BACKGROUND

• 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. doi: 10.1016/s0015-0282(02)03362-9.

  PMID: 12414003 BACKGROUND

• Guney 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. doi: 10.1097/01.AOG.0000223201.42144.80.

  PMID: 16816065 BACKGROUND

• Nelson AL, Fong JK. Intrauterine infusion of lidocaine does not reduce pain scores during IUD insertion. Contraception. 2013 Jul;88(1):37-40. doi: 10.1016/j.contraception.2012.12.009. Epub 2013 Jan 2.

  PMID: 23375352 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

This was a small pilot study, so may have missed small differences in pain score. Based on the results obtained, a sample size of 418 subjects would be needed to detect a statistically significant difference in the pain scores.

Results Point of Contact

• Title: Dr. Anita Nelson
• Organization: Harbor-UCLA Medical Center

anitanelsonwhc@earthlink.net

310-222-3871

Study Officials

• Anita L Nelson, M.D.

  Women's Health Care Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: March 9, 2011
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2012
• Last Updated: February 5, 2014
• Results First Posted: February 5, 2014

Record last verified: 2013-12

Locations

US (1)