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

NCT ID: NCT02536235

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention: intraoperative topical heat

Group Type: EXPERIMENTAL

heat

Intervention Type: OTHER

activated heating pad to lower abdomen

Control: no intraoperative heat

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

heat

activated heating pad to lower abdomen

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Planned Parenthood of Greater New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

PPNYC

Locations

Planned Parenthood- Boro Hall

Brooklyn, New York, United States

Countries

United States

Other Identifiers

SFPRF15-20

Identifier Type: -

Identifier Source: org_study_id