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For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental, IUD Insertion group | Experimental | If the subject is assigned to the experimental group (vaginal lidocaine jelly): She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. |
|
| Control, IUD Insertion group | Placebo Comparator | If the subject is assigned to the control group (sterile, surgical lubricant jelly): •She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal 2% Lidocaine | Drug | Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly |
|
| Measure | Description | Time Frame |
|---|---|---|
| (IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion | Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. | 0-3 minutes after procedure completed |
| Measure | Description | Time Frame |
|---|---|---|
| Anticipated Pain as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. | 30 Minutes prior to procedure |
| Baseline Pain as Measured by a Visual Analog Scale |
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Inclusion Criteria:
Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.
Exclusion Criteria:
Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Conti, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Gynecology Clinic | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30444982 | Derived | Conti JA, Lerma K, Schneyer RJ, Hastings CV, Blumenthal PD, Shaw KA. Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Feb;220(2):177.e1-177.e7. doi: 10.1016/j.ajog.2018.11.1085. Epub 2018 Nov 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental, IUD Insertion Group | If the subject is assigned to the experimental group (vaginal lidocaine jelly): She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly |
| FG001 | Control, IUD Insertion Group | If the subject is assigned to the control group (sterile, surgical lubricant jelly): •She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental, IUD Insertion Group | If the subject is assigned to the experimental group (vaginal lidocaine jelly): She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | (IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion | Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. | Per protocol analysis | Posted | Median | Full Range | score on a scale | 0-3 minutes after procedure completed |
|
Adverse event data for each subject was assessed from time of consent to time of appointment discharge. On average this was 90 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental, IUD Insertion Group | If the subject is assigned to the experimental group (vaginal lidocaine jelly): She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Manager | Stanford University, Department of OB/GYN | 6507211562 | familyplanningresearch@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2016 | Aug 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C042973 | K-Y jelly |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Surgical Lubricant Jelly | Drug | Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly |
|
|
Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. |
| Immediately prior to procedure; upon arrival to procedure room |
| Pain After Speculum Placement as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. | Intraoperative |
| Pain After Tenaculum Placement as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. | Intraoperative |
| BG001 | Control, IUD Insertion Group | If the subject is assigned to the control group (sterile, surgical lubricant jelly): •She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Previous Intrauterine Device Insertion | Participant had a previous intrauterine device insertion. | Count of Participants | Participants |
|
| OG001 | Control, IUD Insertion Group | If the subject is assigned to the control group (sterile, surgical lubricant jelly): •She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly |
|
|
| Secondary | Anticipated Pain as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. | Per protocol analysis | Posted | Median | Full Range | score on a scale | 30 Minutes prior to procedure |
|
|
|
| Secondary | Baseline Pain as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. | Per protocol analysis | Posted | Median | Full Range | score on a scale | Immediately prior to procedure; upon arrival to procedure room |
|
|
|
| Secondary | Pain After Speculum Placement as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. | Per protocol analysis | Posted | Median | Full Range | score on a scale | Intraoperative |
|
|
|
| Secondary | Pain After Tenaculum Placement as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain. | Per protocol analysis | Posted | Median | Full Range | score on a scale | Intraoperative |
|
|
|
| 0 |
| 108 |
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | Control, IUD Insertion Group | If the subject is assigned to the control group (sterile, surgical lubricant jelly): •She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly | 0 | 107 | 0 | 107 | 0 | 107 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |