Pain
Conditions
Keywords
Pain during first-trimester surgical abortion
Brief summary
The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that varying paracervical block techniques might have on that pain. These different techniques involve wait time following the injection as well as the number of sites injected.
Detailed description
The investigators plan to conduct a single-blinded randomized trial of 350 women undergoing elective first-trimester surgical abortion. Subjects will be randomized to two different paracervical block techniques, but both the medications and the amount of medications will remain the same. Subjects will not know to which group they have been randomized as this knowledge may affect how much pain is felt. Primary Outcome: Patient reported pain with cervical dilation during first trimester surgical abortion. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation. The 100-mm VAS scale is a well established and validated study instrument. Secondary Outcomes: 1. Socio-demographic and clinical data: age, race, gravidity, parity, gestational age, prior vaginal delivery, prior abortion, level of menstrual symptoms 2. Pain (VAS scale): * anticipated * baseline * with speculum insertion * with placement of the PCB * with aspiration * 30 min postoperatively * intrapersonal pain changes (calculated in analysis) * anxiety \[baseline\] (VAS scale; anchors 0 = none, 100mm = worst imaginable): * of pain * of surgery * satisfaction (VAS scale; anchors 0 = not, 100mm = very satisfied): * with pain control * overall abortion experience * adverse events * need for additional intraoperative and/or postoperative pain medication * participants' belief if they were in the intervention or control group
Interventions
DRUGParacervical block technique with lidocaine
The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
Sponsors
Planned Parenthood Federation of America
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18 years or older * voluntarily requesting pregnancy termination * ultrasound-confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age * generally healthy * English or Spanish speaking * able or willing to sign an informed consent and agree to terms of the study
Exclusion criteria
* gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this gestational age at the study sites) * incomplete abortion * failed medical abortion * required or requested IV sedation (prior to randomization) * patient who declines Ibuprofen, Lorazepam or PCB * medical contraindication or allergy to any of the study medications * chronic use of narcotic pain medication or heroin * significant physical or mental health condition * adnexal mass or tenderness on pelvic exam consistent with inflammatory disease * known hepatic disease * women who, in the opinion of the investigator, are not suitable for the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perception of Pain | after completion of cervical dilation | To determine whether varying paracervical block techniques affect patient perception of pain. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores Throughout Procedure at Various Time Points | up to several hours | Distance (mm) from the left of the 100 mm Visual Analog Scale (VAS anchors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure: * prior to medication (baseline) * after speculum insertion * with placement of PCB * with cervical dilation * with aspiration * 30 minutes post-operatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 4-site Injection The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period. | 83 |
| 2-site Injection The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period. | 80 |
| 4-Site PCB Followed by 3-minute Wait Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period. | 80 |
| 4-site PCB Followed by no Wait Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period. | 83 |
| Total | 326 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Missing Data | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 3 | 2 | 0 |
Baseline characteristics
| Characteristic | 2-site Injection | 4-Site PCB Followed by 3-minute Wait | 4-site Injection | 4-site PCB Followed by no Wait | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 80 Participants | 83 Participants | 83 Participants | 326 Participants |
| Age, Continuous | 25.5 years STANDARD_DEVIATION 5.3 | 25.2 years STANDARD_DEVIATION 5.2 | 25.2 years STANDARD_DEVIATION 5.2 | 26.4 years STANDARD_DEVIATION 5.5 | 25.575 years STANDARD_DEVIATION 5.3 |
| Region of Enrollment United States | 80 participants | 80 participants | 83 participants | 83 participants | 326 participants |
| Sex: Female, Male Female | 80 Participants | 80 Participants | 83 Participants | 83 Participants | 326 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 80 | 0 / 80 | 0 / 83 |
| other Total, other adverse events | 0 / 83 | 0 / 80 | 0 / 80 | 0 / 83 |
| serious Total, serious adverse events | 0 / 83 | 0 / 80 | 0 / 80 | 0 / 83 |
Outcome results
Primary
Patient Perception of Pain
To determine whether varying paracervical block techniques affect patient perception of pain. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation.
Time frame: after completion of cervical dilation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-site Injection | Patient Perception of Pain | 60 mm | Standard Deviation 30 |
| 2-site Injection | Patient Perception of Pain | 68 mm | Standard Deviation 21 |
| 4-Site PCB Followed by 3-minute Wait | Patient Perception of Pain | 56 mm | Standard Deviation 32 |
| 4-site PCB Followed by no Wait | Patient Perception of Pain | 63 mm | Standard Deviation 24 |
Secondary
Pain Scores Throughout Procedure at Various Time Points
Distance (mm) from the left of the 100 mm Visual Analog Scale (VAS anchors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure: * prior to medication (baseline) * after speculum insertion * with placement of PCB * with cervical dilation * with aspiration * 30 minutes post-operatively
Time frame: up to several hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4-site Injection | Pain Scores Throughout Procedure at Various Time Points | With aspiration | 67.75 mm | Standard Error 2.52 |
| 4-site Injection | Pain Scores Throughout Procedure at Various Time Points | After speculum insertion | 29.35 mm | Standard Error 2.43 |
| 4-site Injection | Pain Scores Throughout Procedure at Various Time Points | With placement of PCB | 58.89 mm | Standard Error 2.64 |
| 4-site Injection | Pain Scores Throughout Procedure at Various Time Points | With cervical dilation | 59.76 mm | Standard Error 2.84 |
| 4-site Injection | Pain Scores Throughout Procedure at Various Time Points | 30 minutes post-operatively | 26.27 mm | Standard Error 2.56 |
| 4-site Injection | Pain Scores Throughout Procedure at Various Time Points | Prior to medication (baseline) | 7.65 mm | Standard Error 1.27 |
| 2-site Injection | Pain Scores Throughout Procedure at Various Time Points | 30 minutes post-operatively | 22.37 mm | Standard Error 2.3 |
| 2-site Injection | Pain Scores Throughout Procedure at Various Time Points | With cervical dilation | 68.41 mm | Standard Error 2.9 |
| 2-site Injection | Pain Scores Throughout Procedure at Various Time Points | With placement of PCB | 55.31 mm | Standard Error 2.69 |
| 2-site Injection | Pain Scores Throughout Procedure at Various Time Points | With aspiration | 74.05 mm | Standard Error 2.56 |
| 2-site Injection | Pain Scores Throughout Procedure at Various Time Points | After speculum insertion | 27.31 mm | Standard Error 2.47 |
| 2-site Injection | Pain Scores Throughout Procedure at Various Time Points | Prior to medication (baseline) | 4.84 mm | Standard Error 1.3 |
| 4-Site PCB Followed by 3-minute Wait | Pain Scores Throughout Procedure at Various Time Points | After speculum insertion | 29.3 mm | Standard Error 2.7 |
| 4-Site PCB Followed by 3-minute Wait | Pain Scores Throughout Procedure at Various Time Points | With placement of PCB | 60.0 mm | Standard Error 2.8 |
| 4-Site PCB Followed by 3-minute Wait | Pain Scores Throughout Procedure at Various Time Points | 30 minutes post-operatively | 27.3 mm | Standard Error 2.6 |
| 4-Site PCB Followed by 3-minute Wait | Pain Scores Throughout Procedure at Various Time Points | With cervical dilation | 55.6 mm | Standard Error 3.1 |
| 4-Site PCB Followed by 3-minute Wait | Pain Scores Throughout Procedure at Various Time Points | With aspiration | 72.1 mm | Standard Error 2.6 |
| 4-Site PCB Followed by 3-minute Wait | Pain Scores Throughout Procedure at Various Time Points | Prior to medication (baseline) | 4.2 mm | Standard Error 2.5 |
| 4-site PCB Followed by no Wait | Pain Scores Throughout Procedure at Various Time Points | With aspiration | 69.4 mm | Standard Error 2.5 |
| 4-site PCB Followed by no Wait | Pain Scores Throughout Procedure at Various Time Points | With placement of PCB | 58.3 mm | Standard Error 2.8 |
| 4-site PCB Followed by no Wait | Pain Scores Throughout Procedure at Various Time Points | After speculum insertion | 30.3 mm | Standard Error 2.7 |
| 4-site PCB Followed by no Wait | Pain Scores Throughout Procedure at Various Time Points | Prior to medication (baseline) | 6 mm | Standard Error 0.9 |
| 4-site PCB Followed by no Wait | Pain Scores Throughout Procedure at Various Time Points | With cervical dilation | 63.2 mm | Standard Error 3.1 |
| 4-site PCB Followed by no Wait | Pain Scores Throughout Procedure at Various Time Points | 30 minutes post-operatively | 24.2 mm | Standard Error 2.5 |