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

Not Applicable

Completed

• Conditions: Topical Heat Application for Intraoperative Abortion Pain Management
• Interventions: Other: heat

• Registration Number: NCT02536235
• Lead Sponsor: Planned Parenthood of Greater New York

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-31
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: intraoperative topical heat	heat	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.
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.

Trial Locations

Locations (1)

Planned Parenthood- Boro Hall; 🇺🇸 Brooklyn, New York, United States