Pulsed Short Wave Therapy In Cesarean Section

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: RecoveryRx
* Device: Sham RecoveryRx


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Group<br>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<br>* A pulsed shortwave therapy medical device<br>* Other names: pulsed shortwave therapy;|
| Sham Comparator: Control Group<br>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<br>* A sham pulsed shortwave therapy medical device<br>* Other names: Sham pulsed shortwave therapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean section