Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- BioElectronics Corporation
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Medication Use
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
- •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
Arms & Interventions
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.
Intervention: RecoveryRx (Device)
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.
Intervention: Sham RecoveryRx (Device)
Outcomes
Primary Outcomes
Medication Use
Time Frame: Data collected daily for 7 Days
Quantify the use of analgesic medications during 7 days of postoperative recovery.
Secondary Outcomes
- Time to patient Patient Mobility(2 Days)
- Would Closure at Day 7, Wound Complications(7 Days)
- Change in Visual Analogue Pain(Data collected for 7 Days)