PainPhase 4NCT01311102
The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement
A Phase 4 study testing Lidocaine and Normal Saline in people with Pain, run by Women's Health Care Clinic, Torrance, California at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women eligible for IUD insertion
- Willing to give consent
Who cannot join
- Allergy to lidocaine
- Contraindications to IUD use
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Health Care Clinic
Torrance, California, 90502
About this study
Official title: Double Blind, Randomized, Prospective Trial of Impact of Pain Scores on Intrauterine Lidocaine vs Normal Saline Infusion Before IUD Placement.
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.
Read the detailed 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Lidocaine Hydrochloride, Xylocaine
1.33 cc 2% liquid lidocaine
Normal SalineDrug
Also called Sodium chloride
1.33cc normal saline
| Study group | Role | What they receive |
|---|---|---|
| 2% Lidocaine liquid | Experimental | 1.33cc of 2% liquid lidocaine infused in endo cervix and endometrium Receives: Drug: Lidocaine |
| Normal Saline | Placebo comparator | 1.33cc of normal saline infused in endo cervix and endometrium Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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
Measured: 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."
Measured: 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."
Measured: Immediately after IUD placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startJul 2008
- Primary completionDec 2008
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Health Care Clinic, Torrance, California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Nelson, Women's Health Care Clinic, Torrance, California
- Investigators
- Anita L Nelson, M.D., Principal investigator, Women's Health Care Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311102
- Sponsor's protocol ID
- 13531-01
- Status last verified
- Dec 2013
- First submitted
- 21 Jun 2010
- Last updated
- 5 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 14754707Trolice 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.
PubMed 10711541Gupta 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.
PubMed 18603250Lau 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.
PubMed 10826574Guney 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.
PubMed 17478360Edelman 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.
PubMed 16449111Hui 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.
PubMed 16398772Edelman 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.
PubMed 15172863Frishman 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.
PubMed 15172862Costello 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.
PubMed 12414003Guney 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.
PubMed 16816065Nelson 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.
PubMed 23375352
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Prospective Trial of Impact of Pain Scores on Intrauterine Lidocaine vs Normal Saline Infusion Before IUD Placement.
- ClinicalTrials.gov ID
- NCT01311102
- Acronym / sponsor ID
- 13531-01
- Conditions
- Pain
- Keywords
- Pain score, IUD placement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Women's Health Care Clinic, Torrance, CaliforniaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Mar 2011 (estimated)
- Results
- Posted 5 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% Lidocaine liquid | Experimental | Drug: Lidocaine1.33cc of 2% liquid lidocaine infused in endo cervix and endometrium |
| Normal Saline | Placebo comparator | Drug: Normal Saline1.33cc of normal saline infused in endo cervix and endometrium |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women eligible for IUD insertion
- Willing to give consent
Key exclusion criteria (2 listed)
- Allergy to lidocaine
- Contraindications to IUD use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: Lidocaine Hydrochloride, Xylocaine1.33 cc 2% liquid lidocaine | Drug | 2% Lidocaine liquid |
| Normal SalineAlso: Sodium chloride1.33cc normal saline | Drug | Normal Saline |
Primary outcome
Pain Scores During Overall IUD Placement
Time frame: Before patient left the examination room at conclusion of procedure
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."
Pain During Tenaculum Placement
Time frame: Immediately following 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
Pain Measurement During Liquid Infusion/Sounding
Time frame: Recorded at the end of the infusion
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."
Pain During IUD Placement
Time frame: Immediately after 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."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14754707Dogan 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.
- Background: PubMed 10711541Trolice 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.
- Background: PubMed 18603250Gupta 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.
- Background: PubMed 10826574Lau 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.
- Background: PubMed 17478360Guney 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.
- Background: PubMed 16449111Edelman 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.
- Background: PubMed 16398772Hui 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.
- Background: PubMed 15172863Edelman 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.
- Background: PubMed 15172862Frishman 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.
- Background: PubMed 12414003Costello 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.
- Background: PubMed 16816065Guney 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.
- Derived from this study: PubMed 23375352Nelson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita L Nelson, M.D. principal investigator
Women's Health Care Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Normal Saline in people with Pain, run by Women's Health Care Clinic, Torrance, California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores During Overall IUD Placement (time frame: Before patient left the examination room at conclusion of procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311102, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2014.