Postoperative Pain
Conditions
Keywords
Caesarean section
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.
Interventions
DEVICERecoveryRx
A pulsed shortwave therapy medical device
DEVICESham RecoveryRx
A sham pulsed shortwave therapy medical device
Sponsors
BioElectronics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Use | Data collected daily for 7 Days | Quantify the use of analgesic medications during 7 days of postoperative recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Lebanon
Contacts
Primary ContactMahmoud Maassarani, Ph.D
Backup ContactOmar Tabbouche, Pharma D
Outcome results
None listed