Pulsed Short Wave Therapy In Cesarean Section

Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: RecoveryRx; Device: Sham RecoveryRx

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Maassarani, Ph.D; Phone Number: 79156547; Email: M.maassarani@outlook.fr
• Study Contact Backup: Name: Omar Tabbouche, Pharma D; Phone Number: 03433032; Email: omartabbouche@gmail.com

Study Locations

• Lebanon
  • Tripoli, Lebanon
    • Recruiting
    • New Mazloum Hospital
    • Contact: Mahmoud Maassarani, Ph.D; Phone Number: 96179156547; Email: M.maassarani@outlook.fr
  • Tripoli, Lebanon
    • Recruiting
    • Haykal Hospital
    • Contact: Omar Tabbouche, Pharm D; Phone Number: +9613433032; Email: omartabbouche@gmail.com
    • Principal Investigator: Moustafa Chaaban, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Group; 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.	Device: RecoveryRx; A pulsed shortwave therapy medical device; Other Names: pulsed shortwave therapy
Sham Comparator: Control Group; 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.	Device: Sham RecoveryRx; A sham pulsed shortwave therapy medical device; Other Names: Sham pulsed shortwave therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Use	Quantify the use of analgesic medications during 7 days of postoperative recovery.	Data collected daily for 7 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Data collected for 7 Days
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.	2 Days
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	7 Days

Collaborators and Investigators

• Sponsor: BioElectronics Corporation
• Investigators: Principal Investigator: Moustafa Chaaban, MD, Haykal Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Caesarean section
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: PRO180401

Drug and device information, study documents

• 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