Completed

NCT Number: NCT02536235

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

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.

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Key information

Conditions

Topical Heat Application for Intraoperative Abortion Pain Management

Age range

16 year–51 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood- Boro Hall

Brooklyn, New York, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heat

Other

activated heating pad to lower abdomen

Primary outcomes

pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration

Time frame: 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 outcomes

pain score measured on VAS at time of speculum placement

Time frame: 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 paracervical block

Time frame: 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

Time frame: 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 cervical dilation

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Planned Parenthood of Greater New York

Other

Collaborators

Icahn School of Medicine at Mount Sinai

Registry information

Official study title

Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortion: A Randomized Controlled Trial

Acronym: HAPPE

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 31, 2015
Registry last updated: Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.