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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Active Comparator | 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. |
|
| Control Group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RecoveryRx | Device | A pulsed shortwave therapy medical device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication Use | Quantify the use of analgesic medications during 7 days of postoperative recovery. | Data collected daily for 7 Days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Maassarani, Ph.D | Contact | 79156547 | M.maassarani@outlook.fr | |
| Omar Tabbouche, Pharma D | Contact | 03433032 | omartabbouche@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Moustafa Chaaban, MD | Haykal hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haykal hospital | Recruiting | Tripoli | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32871021 | Derived | Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Sham RecoveryRx | Device | A sham pulsed shortwave therapy medical device |
|
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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 |
| New Mazloum Hospital | Recruiting | Tripoli | Lebanon |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |