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| ID | Type | Description | Link |
|---|---|---|---|
| SFP1-1 | Other Grant/Funding Number | Society of Family Planning |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone.
This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS.
The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paracervical block with lidocaine | Active Comparator | Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion |
|
| paracervical block with ketorolac and lidocaine | Experimental | Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine | Drug | paracervical block with lidocaine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Pain During Specific Time Intervals Throughout D&C Procedure. | 100-mm Visual Analogue Scale (VAS) during specific time intervals of D&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain) Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure. | Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale Regarding Satisfaction Level | 100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction) | end of study (prior to clinic discharge) |
| Reported Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johns Hopkins University, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Columbia-Willamette | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19935022 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracervical Block With Lidocaine | Subjects who received paracervical block with 18 mL of 1% lidocaine and 2 mL of saline for pain control during first trimester surgical abortion |
| FG001 | Paracervical Block With Ketorolac and Lidocaine | Subjects who received pain control of paracervical block with combined 30mg of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paracervical Block With Lidocaine | Subjects who received pain control with paracervical block with 18mL of 1% lidocaine and 2mL of saline during first trimester surgical abortion |
| BG001 | Paracervical Block With Ketorolac and Lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | 100-mm Visual Analogue Scale (VAS) during specific time intervals of D&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain) Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure. | Posted | Mean | Standard Deviation | mm | Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure |
|
Data collected during study participation (receipt of written informed consent until 2-4 week follow-up by phone or clinic visit)
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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 | Paracervical Block With Lidocaine | Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| immediate postoperative hemorrhage | Reproductive system and breast disorders | Systematic Assessment | Subject experienced hemorrhage (400mL) most likely due to subject's known leiomyoma. Subject was treated conservatively as an outpatient and did not require blood transfusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| reported symptoms | Reproductive system and breast disorders | Systematic Assessment | Secondary outcomes assessed included fever, chills, vomiting, heavy bleeding/clots. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Cansino | University of California, Davis | 9167346930 | Catherine.Cansino@ucdmc.ucdavis.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| ketorolac and lidocaine |
| Drug |
paracervical block with ketorolac and lidocaine |
|
fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)
| end of study (upon discharge from facility after procedure) |
| Complications | end of study |
Subjects who received pain control with paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion |
| 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 |
|
| gestational age | Mean | Standard Deviation | days |
|
| gravidity | Number | participants |
|
| prior vaginal deliveries | Number | participants |
|
| prior abortions | Number | participants |
|
| level of provider performing procedure | Number | participants |
|
| institution | Number | participants |
|
| level of menstrual symptoms | Number | participants |
|
Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion |
|
|
|
| Secondary | Visual Analogue Scale Regarding Satisfaction Level | 100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction) | Posted | Mean | Standard Deviation | mm | end of study (prior to clinic discharge) |
|
|
|
|
| Secondary | Reported Symptoms | fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event) | Posted | Number | participants | end of study (upon discharge from facility after procedure) |
|
|
|
|
| Secondary | Complications | Posted | Number | participants | end of study |
|
|
|
|
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Paracervical Block With Ketorolac and Lidocaine | Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion | 1 | 25 | 0 | 25 |
|
| repeat procedure | Reproductive system and breast disorders | Systematic Assessment | Subject underwent uncomplicated repeat vacuum aspiration procedure on postoperative day 3. |
|
|
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| Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 0.15 |
| Superiority or Other |