NCT01383122

Brief Summary

Pain following Cesarean delivery remains the most common post-operative complaint, and the provision of effective and safe analgesia is very important. Pain can impede the mother's ability to mobilise, and to care for and breastfeed her newborn baby. Pulsed electromagnetic field (PEMF) devices have been used in various clinical settings, especially after plastic surgeries, to reduce postoperative swelling and pain, as well as to accelerate wound repair. PEMF therapy is simple to use, cost-effective and has no known side effects. Despite advances in post-operative analgesia, pain relief and maternal satisfaction remain inadequate in some patients. Improving the quality of post-Cesarean analgesia while limiting undesirable side effects will enhance maternal satisfaction and reduce the risk of post-operative complications. The investigators hypothesize that the continuous use of a PEMF device for 48 hours after Cesarean delivery will result in decreased post-operative pain scores on movement at 48 hours.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

8 months

First QC Date

June 24, 2011

Last Update Submit

March 23, 2012

Conditions

Pain

Keywords

Pulsed electromagnetic field deviceCesarean section

Outcome Measures

Primary Outcomes (1)

  • Pain score by visual analogue scale (VAS) on movement at 48 hours postoperatively

    48 hours

Secondary Outcomes (4)

  • Pain at rest and on movement by VAS, and maternal satisfaction at 24 & 48 hours postoperatively

    48 hours

  • Opioid consumption at 24 & 48 hours postoperatively

    48 hours

  • Assessment of side effects: nausea, vomiting, sedation & itchiness

    48 hours

  • Presence of pain 6 weeks postoperatively

    6 weeks

Study Arms (2)

Active device

ACTIVE COMPARATOR

Functional pulsed electromagnetic field device

Device: Pulsed electromagnetic field device (ActiPatch TM)

Placebo - inactive device

PLACEBO COMPARATOR

Inactive pulsed electromagnetic field device

Device: Inactive pulsed electromagnetic field device (ActiPatch TM)

Interventions

Pulsed electromagnetic field device (ActiPatch TM)DEVICE

Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.

Also known as: ActiPatch TM
Active device
Inactive pulsed electromagnetic field device (ActiPatch TM)DEVICE

Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.

Also known as: ActiPatch TM
Placebo - inactive device

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years or older
  • full term singleton pregnancy
  • undergoing elective cesarean delivery

You may not qualify if:

  • Patients who have refused, are unable to give or have withdrawn consent
  • Patients unable to communicate fluently in English
  • Patients with American Society of Anesthesiologists (ASA) classification of 3 or greater
  • Patients with chronic pain, or neuropathic analgesic drugs
  • Patients in use of antidepressant and psychotropic drugs
  • Patients with a history of opioid or intravenous drug abuse
  • Patients with known allergy or contra-indication to any other drugs used in this trial
  • Patients who have refused spinal anesthesia, or those in whom it is contra-indicated
  • Patients with a history of previous cesarean delivery and persistent pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

  • Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

    PMID: 32871021DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose CA Carvalho, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 28, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

CA(1)