Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Planned Parenthood Federation of America | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cervical dilators are frequently used for preparation prior to second trimester surgical abortion. While their use decreases complications associated with surgical abortion, their placement is often uncomfortable for the patient. Currently there are no proven methods for reducing pain during osmotic dilator placement. The use of numbing medication around the cervix (paracervical block) may decrease this placement pain.
It is estimated that 1.21 million abortions were performed in 2008. Of these, approximately 11% occurred in the second trimester and 1.4% occurred after 21 weeks gestation. In the United States, dilation and evacuation (D&E) is the most common method of terminating a second trimester pregnancy with greater than 98% of second trimester abortions occurring by D&E.
Pre-procedure cervical preparation decreases the incidence of complications associated with D&E. Cervical dilators are often used prior to second trimester D&Es to aid in softening and dilating the cervix. Typically, dilator placement occurs the day of the D&E or 1-2 days prior and oftentimes occurs in an outpatient clinic setting without anesthesia readily available. Many women experience moderate to severe discomfort with osmotic dilator insertion. Providers use various methods to minimize this discomfort including paracervical block (PCB), non-steroidal anti-inflammatory medications (NSAIDs), anxiolytics and narcotics. In particular, PCB and NSAIDs are readily available in the clinic setting and can be used for this purpose. There is, however, no data to support their efficacy in ameliorating the pain of dilator insertion.
Paracervical blocks are used commonly to decrease pain in abortion procedures and other gynecological procedures. The PCB is thought to work primarily by blocking pain conduction via Frankenhauser's plexus. As such, their effect may be most important in relieving the pain associated with cervical dilation. In a recent randomized control trial, PCB prior to first trimester surgical abortion was found to significantly reduce pain with cervical dilation and uterine aspiration. Since osmotic dilator placement primarily involves cervical manipulation and dilation, PCB may provide some pain relief over placebo. The research team proposes a randomized controlled trial to evaluate the efficacy of a PCB in decreasing pain associated with osmotic dilator placement. This trial will also provide information about the degree of pain that women experience during osmotic dilator placement; information not previously known.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Group | Sham Comparator | This non-intervention group will receive the sham paracervical block. This intervention will include
|
|
| Paracervical Block Group | Experimental | This intervention group will receive the paracervical block. This intervention will include
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthetic for tenaculum placement | Procedure | 2 mL of buffered Lidocaine injected superficially at anterior lip of cervix in 12 o'clock position Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Time of Osmotic Dilator Placement | Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after osmotic dilator placement. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain. | Within 5 minutes of PCB or sham procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain With Paracervical Block or Sham | Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after last injection for paracervical block OR script for sham injection. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain. | Within 5 minutes after baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Bayer, MD MPH | UCSD Department of Reproductive Medicine | Principal Investigator |
| Sheila Mody, MD MPH | UCSD Department of Reproductive Medicine | Principal Investigator |
| Kelly Culwell, MD MPH | Planned Parenthood of the Pacific Southwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of the Pacific Southwest: First Avenue Family Planning Michelle Wagner Center | San Diego | California | 92101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11166751 | Background | Glantz JC, Shomento S. Comparison of paracervical block techniques during first trimester pregnancy termination. Int J Gynaecol Obstet. 2001 Feb;72(2):171-8. doi: 10.1016/s0020-7292(00)00292-7. | |
| 14622683 | Background | Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sham Group | This non-intervention group will receive the sham paracervical block. This intervention will include
|
| FG001 | Paracervical Block Group | This intervention group will receive the paracervical block. This intervention will include
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sham Group | This non-intervention group will receive the sham paracervical block. This intervention will include
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain at Time of Osmotic Dilator Placement | Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after osmotic dilator placement. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain. | Posted | Mean | Standard Deviation | units on a scale | Within 5 minutes of PCB or sham procedure |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Group | This non-intervention group will receive the sham paracervical block. This intervention will include
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ob/Gyn Regulatory Specialist, Women's Health Research Unit | Oregon Health & Science University | 503-494-3666 | whru@ohsu.edu |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| C005703 | salicylhydroxamic acid |
| D000773 | Anesthesia, Obstetrical |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham | Procedure | Over 60 seconds, without moving the tenaculum, a capped needle gently touches the vaginal sidewall at the level of the external os at 4 and 8 o'clock positions |
|
| Paracervical Block | Procedure | 18 mL of buffered Lidocaine is slowly injected into the vaginal fornices and equally distributed at 4 and 8 o'clock. The injection is continuous from superficial to deep (3cm) to superficial (injecting with insertion and withdrawal) Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate |
|
| Dilator Placement | Procedure | Osmotic dilators will be placed in the usual fashion with a combination of Dilapan-S and laminaria per clinician preference Drugs: Dilapan-S is a hygroscopic cervical dilator made of a patented hydrogel called AQUACRYL. It is a rigid hydrophilic stick that increases in volume by absorbing fluids and comfortably dilating the cervix. Laminaria is an herbal medicine used to induce labor and abortion. The dried stem of Laminaria mechanically dilates the cervical opening by absorbing water and swelling to several times its original diameter. |
|
| Post-procedural assessment | Behavioral | 15 minutes after procedure, subjects will complete a questionnaire that collects information about pain, negative symptoms, and assessment of how effective their pain management was. |
|
| Preprocedural pain control | Drug | 800 mg Ibuprofen taken before dilator placement |
|
| Reported Pain at Baseline | Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) of pain recorded at baseline prior to the paracervical block or sham block procedure. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain. | Baseline, just prior to PCB or sham procedure |
| Pain With Overall Dilator Placement | Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded 15 minutes after osmotic dilator placement. mm=No Pain and 100 mm= worst possible pain. A higher mean score indicates a higher level of pain experienced at this time point. | 15 minutes after dilator placement |
| UCSD Medical Offices South: Women's Health Services | San Diego | California | 92103 | United States |
| 18318867 | Background | Jones RK, Zolna MR, Henshaw SK, Finer LB. Abortion in the United States: incidence and access to services, 2005. Perspect Sex Reprod Health. 2008 Mar;40(1):6-16. doi: 10.1363/4000608. |
| 6866362 | Background | Peterson WF, Berry FN, Grace MR, Gulbranson CL. Second-trimester abortion by dilatation and evacuation: an analysis of 11,747 cases. Obstet Gynecol. 1983 Aug;62(2):185-90. |
| 19935022 | Background | Cansino C, Edelman A, Burke A, Jamshidi R. Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1220-1226. doi: 10.1097/AOG.0b013e3181c1a55b. |
| 11690725 | Background | Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-132. doi: 10.1016/S0304-3959(01)00371-2. No abstract available. |
| 6133988 | Background | Schulz KF, Grimes DA, Cates W Jr. Measures to prevent cervical injury during suction curettage abortion. Lancet. 1983 May 28;1(8335):1182-5. doi: 10.1016/s0140-6736(83)92464-9. |
| 17119534 | Background | Strauss LT, Gamble SB, Parker WY, Cook DA, Zane SB, Hamdan S; Centers for Disease Control and Prevention. Abortion surveillance--United States, 2003. MMWR Surveill Summ. 2006 Nov 24;55(11):1-32. |
| 8604867 | Background | Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x. |
| BG001 |
| Paracervical Block Group |
This intervention group will receive the paracervical block. This intervention will include
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Paracervical Block Group |
This intervention group will receive the paracervical block. This intervention will include
|
|
|
| Secondary | Pain With Paracervical Block or Sham | Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after last injection for paracervical block OR script for sham injection. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain. | Posted | Mean | Standard Deviation | units on a scale | Within 5 minutes after baseline |
|
|
|
| Secondary | Reported Pain at Baseline | Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) of pain recorded at baseline prior to the paracervical block or sham block procedure. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline, just prior to PCB or sham procedure |
|
|
|
| Secondary | Pain With Overall Dilator Placement | Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded 15 minutes after osmotic dilator placement. mm=No Pain and 100 mm= worst possible pain. A higher mean score indicates a higher level of pain experienced at this time point. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes after dilator placement |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Paracervical Block Group | This intervention group will receive the paracervical block. This intervention will include
| 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
Not provided
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |