Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortionl (HAPPE)

Planned Parenthood of Greater New York

Status: Completed

Conditions: Topical Heat Application for Intraoperative Abortion Pain Management

Treatments: Other: heat

Study type: Interventional

Funder types: Other

Identifiers

NCT02536235

SFPRF15-20

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 16 to 51 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Intervention: intraoperative topical heat

Experimental group

Treatment:

Other: heat

Control: no intraoperative heat

No Intervention group