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Pulsed Short Wave Therapy In Cesarean Section

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
RecoveryRx
Sham RecoveryRx
Sponsored by
BioElectronics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Caesarean section

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Voluntarily
  • Performed using spinal anesthesia
  • ASA I (Normal healthy patients) and II (Patients with mild systemic disease) (as defined by the American Society of Anesthesiologists Physical Status Classification system)
  • PARA 0000, 1, 2, 3 [i.e. First, Second, or Third C-Section)
  • At term pregnancy (>38 weeks)
  • BMI <35
  • Age between 18 - 50 years

Exclusion Criteria:

  • Longitudinal surgical incision
  • Placental abnormalities noted
  • Time of extraction of the fetus >10 min from cutaneous incision
  • Blood loss during surgery of >800 ml
  • Any of the conditions not considered in inclusion criteria

Sites / Locations

  • Haykal hospitalRecruiting
  • New Mazloum HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Group

Control Group

Arm Description

Patients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as an active RecoveryRx Pulsed Short Wave Therapy device.

Patients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as a sham RecoveryRx Pulsed Short Wave Therapy device.

Outcomes

Primary Outcome Measures

Medication Use
Quantify the use of analgesic medications during 7 days of postoperative recovery.

Secondary Outcome Measures

Change in Visual Analogue Pain
The visual analog scale (VAS) has been used extensively for rating pain intensity in previous studies. Postoperative pain will be measured daily over a 7 day recovery period
Time to patient Patient Mobility
The benefits of mobility outlined in current nursing textbooks indicate that "Early ambulation is the most significant general nursing measure to prevent postoperative complications". There the time in hours after the c-section operation when the patient becomes mobile(walking) will be used recorded.
Would Closure at Day 7, Wound Complications
presence of edema, erythema,hematoma, and exudate from the surgical wound on the seventh postoperative day that could impair woundhealing process

Full Information

First Posted
June 5, 2018
Last Updated
July 19, 2018
Sponsor
BioElectronics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03604068
Brief Title
Pulsed Short Wave Therapy In Cesarean Section
Official Title
Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioElectronics Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following Cesarean section. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.
Detailed Description
Pain is ranked highest among undesirable clinical outcomes associated with caesarean section therefore postoperative pain relief following a cesarean section is extremely important to optimize maternal and neonate well being. Multimodial analgesics are effective in reducing postoperative pain but analgesia is still not optimized. Opiate based analgesics are effective but having troubling side effects. Addition of non-drug pain therapies hold promise in improving postoperative recovery while potentially allowing for reduced use of drug based analgesics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Caesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Active Comparator
Arm Description
Patients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as an active RecoveryRx Pulsed Short Wave Therapy device.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Patients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as a sham RecoveryRx Pulsed Short Wave Therapy device.
Intervention Type
Device
Intervention Name(s)
RecoveryRx
Other Intervention Name(s)
pulsed shortwave therapy
Intervention Description
A pulsed shortwave therapy medical device
Intervention Type
Device
Intervention Name(s)
Sham RecoveryRx
Other Intervention Name(s)
Sham pulsed shortwave therapy
Intervention Description
A sham pulsed shortwave therapy medical device
Primary Outcome Measure Information:
Title
Medication Use
Description
Quantify the use of analgesic medications during 7 days of postoperative recovery.
Time Frame
Data collected daily for 7 Days
Secondary Outcome Measure Information:
Title
Change in Visual Analogue Pain
Description
The visual analog scale (VAS) has been used extensively for rating pain intensity in previous studies. Postoperative pain will be measured daily over a 7 day recovery period
Time Frame
Data collected for 7 Days
Title
Time to patient Patient Mobility
Description
The benefits of mobility outlined in current nursing textbooks indicate that "Early ambulation is the most significant general nursing measure to prevent postoperative complications". There the time in hours after the c-section operation when the patient becomes mobile(walking) will be used recorded.
Time Frame
2 Days
Title
Would Closure at Day 7, Wound Complications
Description
presence of edema, erythema,hematoma, and exudate from the surgical wound on the seventh postoperative day that could impair woundhealing process
Time Frame
7 Days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Voluntarily Performed using spinal anesthesia ASA I (Normal healthy patients) and II (Patients with mild systemic disease) (as defined by the American Society of Anesthesiologists Physical Status Classification system) PARA 0000, 1, 2, 3 [i.e. First, Second, or Third C-Section) At term pregnancy (>38 weeks) BMI <35 Age between 18 - 50 years Exclusion Criteria: Longitudinal surgical incision Placental abnormalities noted Time of extraction of the fetus >10 min from cutaneous incision Blood loss during surgery of >800 ml Any of the conditions not considered in inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Maassarani, Ph.D
Phone
79156547
Email
M.maassarani@outlook.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Tabbouche, Pharma D
Phone
03433032
Email
omartabbouche@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustafa Chaaban, MD
Organizational Affiliation
Haykal hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haykal hospital
City
Tripoli
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Tabbouche, Pharm D
Phone
+9613433032
Email
omartabbouche@gmail.com
First Name & Middle Initial & Last Name & Degree
Moustafa Chaaban, MD
Facility Name
New Mazloum Hospital
City
Tripoli
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Maassarani, Ph.D
Phone
96179156547
Email
M.maassarani@outlook.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
32871021
Citation
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.
Results Reference
derived

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Pulsed Short Wave Therapy In Cesarean Section

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