Pulsed Short Wave Therapy In Cesarean Section

Not Applicable

• Conditions: Postoperative Pain

• Registration Number: NCT03604068
• Lead Sponsor: BioElectronics Corporation

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.

Study Timeline

• Study Start: 2018-04-01
• Status Verified: 2018-05
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-07-19
• Last Update Submitted: 2018-07-19
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication Use	Data collected daily for 7 Days	Quantify the use of analgesic medications during 7 days of postoperative recovery.

Secondary Outcome Measures

Name	Time	Method
Time to patient Patient Mobility	2 Days	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	7 Days	presence of edema, erythema,hematoma, and exudate from the surgical wound on the seventh postoperative day that could impair woundhealing process
Change in Visual Analogue Pain	Data collected for 7 Days	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

Trial Locations

Locations (2)

Haykal hospital; 🇱🇧 Tripoli, Lebanon

New Mazloum Hospital; 🇱🇧 Tripoli, Lebanon