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

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

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.

Study Overview

• Status: Completed
• Conditions: Topical Heat Application for Intraoperative Abortion Pain Management
• Intervention / Treatment: Other: heat

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States
      • Planned Parenthood- Boro Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 51 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: intraoperative topical heat	Other: heat; activated heating pad to lower abdomen
No Intervention: Control: no intraoperative heat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration	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.	collected at time of procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score measured on VAS at time of speculum placement	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.	collected at time of procedure.
pain score measured on VAS at time of paracervical block	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.	collected at time of procedure.
pain score measured on VAS at time of tenaculum placemenet	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.	collected at time of procedure.
pain score measured on VAS at time of cervical dilation	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.	collected at time of procedure.
overall pain scores will be measured on VAS at the conclusion of the 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.	collected at conclusion of procedure.
overall satisfaction with pain management will be measured on a 5 point Likert scale	Likert scale assessing satisfaction will be based on scale from 0 to 4 where 0 equals very unsatisfied and 4 equals very satisfied.	collected at conclusion of procedure

Collaborators and Investigators

• Sponsor: Planned Parenthood of Greater New York
• Collaborators: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Principal Investigator, PPNYC

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimate): August 31, 2015

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: September 27, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: SFPRF15-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED