Topical Heat Application for Intraoperative Abortion Pain Management
Conditions
Brief summary
Paracervical blocks are routinely used in first trimester surgical abortions and are a proven method for decreasing procedural pain. Even when paracervical anesthesia is used, an overwhelming majority of women still report at least moderate pain during a first trimester abortion procedure. Other than some non-pharmacologic modalities (music and visualization), only the addition of intravenous medication has been shown to reduce procedural pain. Applied topical heat is effective in alleviating pain in other medical subspecialties, and in gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for intraoperative pain control during first trimester abortion. The investigators plan to conduct a double-blinded, randomized, controlled trial investigating the utility of topical heat application as an adjunct to paracervical block in first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score, measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators will look at the effect of heat application on pain at time of speculum placement, paracervical block, tenaculum placement, cervical dilation and overall pain. Patient satisfaction will also be assessed. If found to reduce pain during abortion under local anesthesia, the use of heat could offer an inexpensive, safe and universally available adjunct to the paracervical block during this procedure.
Interventions
OTHERheat
activated heating pad to lower abdomen
Sponsors
Icahn School of Medicine at Mount Sinai
Planned Parenthood of Greater New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 51 Years
Healthy volunteers
Yes
Inclusion criteria
* Gestational age of 12 6/7 wks or less by ultrasound * Age 16 years or older * Requesting pregnancy termination by surgical abortion * Eligible for outpatient pregnancy termination * Able to provide informed consent * English or Spanish\* speaking \*If research assistant hired for project is bilingual * Electing local anesthesia only
Exclusion criteria
* Reports active bleeding or severe pain at time of enrollment * Early pregnancy failure identified on pre-operative ultrasound * Skin irritation or rash over lower abdomen * Presumed molar pregnancy * Possible ectopic pregnancy * Electing intravenous sedation * Planned intra-operative sonographic guidance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration | collected at time of procedure. | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain score measured on VAS at time of paracervical block | collected at time of procedure. | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. |
| pain score measured on VAS at time of tenaculum placemenet | collected at time of procedure. | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. |
| pain score measured on VAS at time of speculum placement | collected at time of procedure. | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. |
| overall pain scores will be measured on VAS at the conclusion of the procedure | collected at conclusion of procedure. | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded at the conclusion of the procedure. |
| overall satisfaction with pain management will be measured on a 5 point Likert scale | collected at conclusion of procedure | Likert scale assessing satisfaction will be based on scale from 0 to 4 where 0 equals very unsatisfied and 4 equals very satisfied. |
| pain score measured on VAS at time of cervical dilation | collected at time of procedure. | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. |
Countries
United States
Outcome results
None listed