Postoperative PainNCT03604068
Pulsed Short Wave Therapy In Cesarean Section
A study testing RecoveryRx in people with Postoperative Pain, run by BioElectronics Corporation at 2 sites in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- RecoveryRx
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesLebanon
- Study dates
- 1 Apr 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Lebanon2 sites, 2 recruiting
- Recruiting
Haykal hospital
Tripoli
Omar Tabbouche, Pharm D, +9613433032, omartabbouche@gmail.com
Moustafa Chaaban, MD
- Recruiting
New Mazloum Hospital
Tripoli
Mahmoud Maassarani, Ph.D, 96179156547, M.maassarani@outlook.fr
About this study
Official title: Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- RecoveryRx, Sham RecoveryRx
- Keywords
- Caesarean section
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecoveryRxDevice
Also called pulsed shortwave therapy
A pulsed shortwave therapy medical device
Sham RecoveryRxDevice
Also called Sham pulsed shortwave therapy
A sham pulsed shortwave therapy medical device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RecoveryRx |
| 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. Receives: Device: Sham RecoveryRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Use
Quantify the use of analgesic medications during 7 days of postoperative recovery.
Measured: Data collected daily for 7 Days
Secondary outcomes (3)
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
Measured: 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.
Measured: 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
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Apr 2018
- Primary completion1 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioElectronics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moustafa Chaaban, MD, Principal investigator, Haykal hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604068
- Sponsor's protocol ID
- PRO180401
- Status last verified
- May 2018
- First submitted
- 5 Jun 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 32871021
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section
- ClinicalTrials.gov ID
- NCT03604068
- Acronym / sponsor ID
- PRO180401
- Conditions
- Postoperative Pain
- Keywords
- Caesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- BioElectronics CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Device: RecoveryRxPatients 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 | Device: Sham RecoveryRxPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RecoveryRxAlso: pulsed shortwave therapyA pulsed shortwave therapy medical device | Device | Active Group |
| Sham RecoveryRxAlso: Sham pulsed shortwave therapyA sham pulsed shortwave therapy medical device | Device | Control Group |
Primary outcome
Medication Use
Time frame: Data collected daily for 7 Days
Quantify the use of analgesic medications during 7 days of postoperative recovery.
3 secondary outcomes
Change in Visual Analogue Pain
Time frame: Data collected for 7 Days
Time to patient Patient Mobility
Time frame: 2 Days
Would Closure at Day 7, Wound Complications
Time frame: 7 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Derived from this study: PubMed 32871021Zimpel 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moustafa Chaaban, MD principal investigator
Haykal hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RecoveryRx in people with Postoperative Pain, run by BioElectronics Corporation at 2 sites in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Maassarani, Ph.D (79156547, M.maassarani@outlook.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Use (time frame: Data collected daily for 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.