Pulsed Short Wave Therapy In Cesarean Section

BioElectronics Corporation

Status: Unknown

Conditions: Postoperative Pain

Treatments: Device: RecoveryRx; Device: Sham RecoveryRx

Study type: Interventional

Funder types: Industry

Identifiers

NCT03604068

PRO180401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups

Active Group

Active Comparator group

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.

Treatment:

Device: RecoveryRx

Control Group

Sham Comparator group

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.

Treatment:

Device: Sham RecoveryRx