Pain, Surgical Abortion
Conditions
Keywords
Pain associated with first trimester surgical abortion
Brief summary
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.
Interventions
DRUGlidocaine
paracervical block with lidocaine
DRUGketorolac and lidocaine
paracervical block with ketorolac and lidocaine
Sponsors
Oregon Health and Science University
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* age greater than or equal to 18 years * English-speaking * ability and willingness to sign the informed consent * ability and willingness to comply with the terms of the study * voluntary request for pregnancy termination * ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age not exceeding 76 days (10 6/7 weeks) from the first day of the preceding menstrual cycle
Exclusion criteria
* women who require or request sedation * untreated acute cervicitis or pelvic inflammatory disease * contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria * allergic reaction or sensitivity to lorazepam or NSAIDs * chronic NSAID use * history of gastritis or gastric ulcer * acute renal failure or chronic renal disease * chronic liver disease * history of bleeding diathesis * chronic narcotic use * current or past history of illegal drug use (excluding marijuana)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Pain During Specific Time Intervals Throughout D&C Procedure. | Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale Regarding Satisfaction Level | end of study (prior to clinic discharge) | 100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction) |
| Reported Symptoms | end of study (upon discharge from facility after procedure) | fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event) |
| Complications | end of study | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Paracervical Block With Ketorolac and Lidocaine Subjects who received pain control with paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Paracervical Block With Lidocaine | Paracervical Block With Ketorolac and Lidocaine | Total |
|---|---|---|---|
| Age, Continuous | 27 years STANDARD_DEVIATION 6.2 | 25.6 years STANDARD_DEVIATION 5.4 | 26.3 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 24 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| gestational age | 54 days STANDARD_DEVIATION 10.1 | 57.3 days STANDARD_DEVIATION 11 | 55.7 days STANDARD_DEVIATION 10.6 |
| gravidity 1 | 6 participants | 9 participants | 15 participants |
| gravidity 2 | 6 participants | 3 participants | 9 participants |
| gravidity 3 | 5 participants | 2 participants | 7 participants |
| gravidity 4 or greater | 8 participants | 10 participants | 18 participants |
| gravidity Missing data | 0 participants | 1 participants | 1 participants |
| institution Johns Hopkins University | 14 participants | 14 participants | 28 participants |
| institution Oregon Health and Science University | 11 participants | 11 participants | 22 participants |
| level of menstrual symptoms easy | 8 participants | 7 participants | 15 participants |
| level of menstrual symptoms mild cramping, no medications | 9 participants | 4 participants | 13 participants |
| level of menstrual symptoms over-the-counter medication use | 8 participants | 14 participants | 22 participants |
| level of provider performing procedure attending | 16 participants | 18 participants | 34 participants |
| level of provider performing procedure resident/fellow | 9 participants | 7 participants | 16 participants |
| prior abortions 0 | 15 participants | 15 participants | 30 participants |
| prior abortions 1 or more | 10 participants | 9 participants | 19 participants |
| prior abortions Missing data | 0 participants | 1 participants | 1 participants |
| prior vaginal deliveries 0 | 17 participants | 18 participants | 35 participants |
| prior vaginal deliveries 1 or more | 8 participants | 7 participants | 15 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 13 Participants | 25 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 1 / 25 |
Outcome results
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.
Time frame: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracervical Block With Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | expected level of pain during procedure | 52.2 mm | Standard Deviation 20.8 |
| Paracervical Block With Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | after speculum insertion | 33.6 mm | Standard Deviation 23.2 |
| Paracervical Block With Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | during paracervical block administration | 50.8 mm | Standard Deviation 23.6 |
| Paracervical Block With Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | after cervical dilation | 74.8 mm | Standard Deviation 19 |
| Paracervical Block With Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | immediately after procedure | 61.5 mm | Standard Deviation 24.6 |
| Paracervical Block With Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | 30 min after procedure | 21.8 mm | Standard Deviation 22.4 |
| Paracervical Block With Ketorolac and Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | immediately after procedure | 64.3 mm | Standard Deviation 27.4 |
| Paracervical Block With Ketorolac and Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | expected level of pain during procedure | 51.7 mm | Standard Deviation 25.4 |
| Paracervical Block With Ketorolac and Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | after cervical dilation | 59.8 mm | Standard Deviation 25.1 |
| Paracervical Block With Ketorolac and Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | after speculum insertion | 32.7 mm | Standard Deviation 26.6 |
| Paracervical Block With Ketorolac and Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | 30 min after procedure | 17.6 mm | Standard Deviation 21.4 |
| Paracervical Block With Ketorolac and Lidocaine | Level of Pain During Specific Time Intervals Throughout D&C Procedure. | during paracervical block administration | 46.0 mm | Standard Deviation 24.3 |
Comparison: expected level of pain during procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)p-value: 0.9495% CI: [-13.7, 12.6]Regression, Linear
Comparison: after speculum insertion greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)p-value: 0.995% CI: [-15.1, 13.2]Regression, Linear
Comparison: during paracervical block administration greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)p-value: 0.4995% CI: [-18.6, 9]Regression, Linear
Comparison: after cervical dilation greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)p-value: 0.0395% CI: [-28.3, -1.7]Regression, Linear
Comparison: immediately after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)p-value: 0.795% CI: [-12.2, 18]Regression, Linear
Comparison: 30 min after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)p-value: 0.5295% CI: [-17, 8.8]Regression, Linear
Secondary
Complications
Time frame: end of study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paracervical Block With Lidocaine | Complications | minor | 1 participants |
| Paracervical Block With Lidocaine | Complications | serious | 0 participants |
| Paracervical Block With Ketorolac and Lidocaine | Complications | minor | 1 participants |
| Paracervical Block With Ketorolac and Lidocaine | Complications | serious | 2 participants |
Comparison: minor complications greater number is worse (i.e., more complications)p-value: 1Chi-squared
Comparison: serious complicationsp-value: 0.15Chi-squared
Secondary
Reported Symptoms
fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)
Time frame: end of study (upon discharge from facility after procedure)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paracervical Block With Lidocaine | Reported Symptoms | 3 participants |
| Paracervical Block With Ketorolac and Lidocaine | Reported Symptoms | 0 participants |
Comparison: greater number is worse (i.e., more symptoms)p-value: 0.07Chi-squared
Secondary
Visual Analogue Scale Regarding Satisfaction Level
100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)
Time frame: end of study (prior to clinic discharge)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracervical Block With Lidocaine | Visual Analogue Scale Regarding Satisfaction Level | 62.9 mm | Standard Deviation 24.6 |
| Paracervical Block With Ketorolac and Lidocaine | Visual Analogue Scale Regarding Satisfaction Level | 63.6 mm | Standard Deviation 28.1 |
Comparison: greater number is better (i.e., more satisfaction) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less satisfaction); maximum: 100 mm (greater satisfaction) Measured at end of study (i.e., upon clinic discharge)p-value: 0.93Regression, Linear