ContraceptionNCT02769247
Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion
A study testing Naproxen and Lidocaine in people with Contraception and Pain, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Pain
- What is being tested?
- Naproxen and Lidocaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2016
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DEERS-eligible reproductive age women (i.e. Tricare beneficiaries)
- age 18 years and older
- desiring Paragard or Mirena intrauterine device insertion
Who cannot join
- Current pregnancy
- cervical stenosis
- severe medical illness
- known allergy or sensitivity to lidocaine or naproxen
- peptic ulcer disease
- current pelvic inflammatory disease
Show all 9Show fewer
- patients with known renal insufficiency
- patients using chronic NSAIDs or on chronic pain medication
- women desiring Skyla IUD insertion will also be excluded due to infrequency of insertions at WRNMMC
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate.
The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.
- Conditions
- Contraception, Pain
- Being tested
- Naproxen, Lidocaine, placebo
- Keywords
- naproxen, lidocaine, intrauterine device, IUD, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Oral naproxen vs placebo
LidocaineDrug
Intrauterine lidocaine vs normal saline
placeboDrug
either normal saline or empty oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion Receives: Drug: placebo |
| Naproxen/Normal saline | Experimental | Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Receives: Drug: Naproxen; Drug: placebo |
| Placebo oral medication/Lidocaine | Experimental | Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Receives: Drug: Lidocaine; Drug: placebo |
| Naproxen/Lidocaine | Experimental | Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Receives: Drug: Naproxen; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Control With IUD Insertion
visual analog scale (0-10) as assessed by patient within 30 minutes after IUD insertion. Scale is from a minimum of 0, with maximum of 10 with higher scores denoting more pain
Measured: within 30 minutes after IUD insertion
Secondary outcomes (4)
Physician Perceived Pain Control During IUD Insertion
visual analog scale (0-3) as assessed by physician within 30 minutes after IUD insertion Scale is from a minimum of 0, with maximum of 3 with higher scores denoting more pain
Measured: within 30 minutes after IUD insertion
Patient Satisfaction With IUD
Patient satisfaction as rated on a 1-5 scale 30 days post insertion. Scale of 5 means highly satisfied, 1 means unsatisfied.
Measured: 30 days post insertion
Difficulty IUD Insertion
as rated by the physician. Very easy/easy were rated as "easy" whereas difficult/very difficult is difficult.
Measured: within 30 minutes of IUD insertion
Perceived Pain 30 Days Post Insertion
survey patient 30 days later to determine her recollection of pain during insertion (0-10); 10 being the most pain. One patient had no IUD initially inserted and was not included; each arm had patients lost to follow up (3 in placebo arm, 2 in naproxen arm, 4 in placebo/oral medication arm).
Measured: 30 days post IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan Dunlow, MD, Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769247
- Sponsor's protocol ID
- 384645-5
- Status last verified
- Oct 2018
- First submitted
- 6 May 2016
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Miles SM, Shvartsman K, Dunlow S. Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial. Contracept Reprod Med. 2019 Sep 10;4:13. doi: 10.1186/s40834-019-0094-0. eCollection 2019.
PubMed 31516731
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion
- ClinicalTrials.gov ID
- NCT02769247
- Acronym / sponsor ID
- 384645-5
- Conditions
- Contraception, Pain
- Keywords
- naproxen, lidocaine, intrauterine device, IUD, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Posted 8 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.
Detailed description
This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate.
The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: placeboPatient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion |
| Naproxen/Normal saline | Experimental | Drug: Naproxen, Drug: placeboPatient will receive naproxen and intrauterine normal saline prior to IUD insertion |
| Placebo oral medication/Lidocaine | Experimental | Drug: Lidocaine, Drug: placeboPatient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion |
| Naproxen/Lidocaine | Experimental | Drug: Naproxen, Drug: LidocainePatient will receive naproxen and intrauterine lidocaine prior to IUD insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DEERS-eligible reproductive age women (i.e. Tricare beneficiaries)
- age 18 years and older
- desiring Paragard or Mirena intrauterine device insertion
Key exclusion criteria (9 listed)
- Current pregnancy
- cervical stenosis
- severe medical illness
- known allergy or sensitivity to lidocaine or naproxen
- peptic ulcer disease
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 |
|---|---|---|
| NaproxenOral naproxen vs placebo | Drug | Naproxen/Lidocaine, Naproxen/Normal saline |
| LidocaineIntrauterine lidocaine vs normal saline | Drug | Naproxen/Lidocaine, Placebo oral medication/Lidocaine |
| placeboeither normal saline or empty oral capsule | Drug | Naproxen/Normal saline, Placebo, Placebo oral medication/Lidocaine |
Primary outcome
Pain Control With IUD Insertion
Time frame: within 30 minutes after IUD insertion
visual analog scale (0-10) as assessed by patient within 30 minutes after IUD insertion. Scale is from a minimum of 0, with maximum of 10 with higher scores denoting more pain
4 secondary outcomes
Physician Perceived Pain Control During IUD Insertion
Time frame: within 30 minutes after IUD insertion
Patient Satisfaction With IUD
Time frame: 30 days post insertion
Difficulty IUD Insertion
Time frame: within 30 minutes of IUD insertion
Perceived Pain 30 Days Post Insertion
Time frame: 30 days post IUD insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31516731Miles SM, Shvartsman K, Dunlow S. Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial. Contracept Reprod Med. 2019 Sep 10;4:13. doi: 10.1186/s40834-019-0094-0. eCollection 2019.
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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.
Susan Dunlow, MD principal investigator
WRNMMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naproxen and Lidocaine in people with Contraception and Pain, run by Walter Reed National Military Medical Center 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 3 inclusion and 9 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 8 Nov 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2018). 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 Control With IUD Insertion (time frame: within 30 minutes after IUD insertion). 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 NCT02769247, which also lists 1 linked publication.
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 8 Nov 2018.