Clinical trial NCT02536235: Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortionl
Official title: Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Topical Heat Application for Intraoperative Abortion Pain Management
Lead sponsor: Planned Parenthood of Greater New York
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2015-08-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 51
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration
timeFrame: collected at time of procedure.
Secondary outcomes:
measure: pain score measured on VAS at time of speculum placement
timeFrame: collected at time of procedure.
measure: pain score measured on VAS at time of paracervical block
timeFrame: collected at time of procedure.
measure: pain score measured on VAS at time of tenaculum placemenet
timeFrame: collected at time of procedure.
measure: pain score measured on VAS at time of cervical dilation
timeFrame: collected at time of procedure.
measure: overall pain scores will be measured on VAS at the conclusion of the procedure
timeFrame: collected at conclusion of procedure.
measure: overall satisfaction with pain management will be measured on a 5 point Likert scale
timeFrame: collected at conclusion of procedure
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Planned Parenthood- Boro Hall
state: New York
Study officials:
affiliation: PPNYC
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: