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

NCT02536235 | Completed

• 1 other identifier: SFPRF15-20
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Topical Heat Application for Intraoperative Abortion Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• pain score measured on VAS at time of speculum placement

  collected at time of procedure.

• pain score measured on VAS at time of paracervical block

  collected at time of procedure.

• pain score measured on VAS at time of tenaculum placemenet

  collected at time of procedure.

• pain score measured on VAS at time of cervical dilation

  collected at time of procedure.

• overall pain scores will be measured on VAS at the conclusion of the procedure

  collected at conclusion of procedure.

Study Arms (2)

Intervention: intraoperative topical heat

EXPERIMENTAL

Other: heat

Control: no intraoperative heat

NO INTERVENTION

Interventions

heat OTHER

activated heating pad to lower abdomen

Intervention: intraoperative topical heat

Eligibility Criteria

• Age: 16 Years - 51 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood of Greater New York: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Planned Parenthood- Boro Hall

Brooklyn, New York, United States

Location

MeSH Terms

Interventions

Hot Temperature

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Principal Investigator

  PPNYC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 31, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

US (1)