Post Operative PainPhase 4NCT02549105
Lidocaine-Prilocaine Cream (EMLA) Topical Application Versus Wound Infiltration With Lidocaine After Cesarean Section
A Phase 4 study testing EMLA CREAM 5 mg and LIDOCAINE 1 % in people with Post Operative Pain, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- EMLA CREAM 5 mg and LIDOCAINE 1 %
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 4
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years.
- Patient American Society of Anesthesiologists physical status І or П.
- Gestational age of pregnancy of 37w or more.
- Patient have no previous section or have 1or 2 previous sections.
- Patient having no medical disorders.
- Patient with no obstetrical complications.
Who cannot join
- age below18 or above 40.
- Women American Society of Anesthesiologists physical status ш or more.
- Women having more than 2 previous cesarean section.
- Women receive cardio vascular drugs or having history of cardio vascular disease.
- Women with Medical disorders with pregnancy as diabetes milletus.
- Women having obstetrical complications as antepartum hemorrhage, pre-eclampsia or eclampsia.
Show all 9Show fewer
- Women having metabolic, hormonal, respiratory, renal and hepatic disease.
- Women with any severe allergic condition or severe asthma.
- Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
Trial locations and contacts
1 site in 1 country.
AHMED M MAMDOUH, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university Maternity hospital
Cairo, Abbasya, 11821
Maged R Aboseda, professor, 00201069190707, ahmadhassan376@gmail.com
About this study
Official title: A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And Wound Infiltration With Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial
A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.
Read the detailed description
The purpose of this study is to compare the effectiveness of topically applied lidocaine-prilocaine (EMLA) cream with local anesthetic (lidocaine) infiltration on post-cesarean section pain.
Research Question:
Is lidocaine-prilocaine (EMLA) cream application effective as compared to local anesthetic (lidocaine) infiltration on post-caesarean section pain?
Research Hypothesis:
Lidocaine-prilocaine (EMLA) cream application is effective in post_caesarean section pain as compared to local anesthetic (lidocaine) infiltration.
Clinical Application :
Topical Lidocaine-prilocaine (EMLA) cream could be applied frequent times postoperatively, unlike infiltration with local anesthetic.
- Conditions
- Post Operative Pain
- Being tested
- EMLA CREAM 5 mg, LIDOCAINE 1 %
- Keywords
- EMLA CREAM, LIDOCAINE INFILTERATION, PAIN RELIEF
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA CREAM 5 mgDrug
Also called EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25
EMLA CREAM APPLICATION FOR WOUND AFTER CS
LIDOCAINE 1 %Drug
Also called XYLOCAINE
LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS
| Study group | Role | What they receive |
|---|---|---|
| EMLA CREAM | Active comparator | EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS Receives: Drug: EMLA CREAM 5 mg |
| LIDOCAINE INFILTERATION | Active comparator | LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS Receives: Drug: LIDOCAINE 1 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS
Measured: 6 H
Secondary outcomes (1)
POSTOPERATIVE PAIN ACCORDING TO VAS
Measured: 24 H
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, HANY AYAD IBRAHIM, Ain Shams Maternity Hospital
- Investigators
- MAGED R ABO SAEDA, MD, Principal investigator, AIN SHAMS MATERNAL HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549105
- Sponsor's protocol ID
- Ain Shams MH
- Status last verified
- Sep 2015
- First submitted
- 21 Jan 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And Wound Infiltration With Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02549105
- Acronym / sponsor ID
- Ain Shams MH
- Conditions
- Post Operative Pain
- Keywords
- EMLA CREAM, LIDOCAINE INFILTERATION, PAIN RELIEF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Sep 2015 (estimated)
- 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.
A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.
Detailed description
The purpose of this study is to compare the effectiveness of topically applied lidocaine-prilocaine (EMLA) cream with local anesthetic (lidocaine) infiltration on post-cesarean section pain.
Research Question:
Is lidocaine-prilocaine (EMLA) cream application effective as compared to local anesthetic (lidocaine) infiltration on post-caesarean section pain?
Research Hypothesis:
Lidocaine-prilocaine (EMLA) cream application is effective in post_caesarean section pain as compared to local anesthetic (lidocaine) infiltration.
Clinical Application :
Topical Lidocaine-prilocaine (EMLA) cream could be applied frequent times postoperatively, unlike infiltration with local anesthetic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMLA CREAM | Active comparator | Drug: EMLA CREAM 5 mgEMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS |
| LIDOCAINE INFILTERATION | Active comparator | Drug: LIDOCAINE 1 %LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 40 years.
- Patient American Society of Anesthesiologists physical status І or П.
- Gestational age of pregnancy of 37w or more.
- Patient have no previous section or have 1or 2 previous sections.
- Patient having no medical disorders.
Key exclusion criteria (9 listed)
- age below18 or above 40.
- Women American Society of Anesthesiologists physical status ш or more.
- Women having more than 2 previous cesarean section.
- Women receive cardio vascular drugs or having history of cardio vascular disease.
- Women with Medical disorders with pregnancy as diabetes milletus.
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 |
|---|---|---|
| EMLA CREAM 5 mgAlso: EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25EMLA CREAM APPLICATION FOR WOUND AFTER CS | Drug | EMLA CREAM |
| LIDOCAINE 1 %Also: XYLOCAINELIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS | Drug | LIDOCAINE INFILTERATION |
Primary outcome
TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS
Time frame: 6 H
1 secondary outcome
POSTOPERATIVE PAIN ACCORDING TO VAS
Time frame: 24 H
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
AHMED M MAMDOUH, MD contact
MAGED R ABO SAEDA, MD principal investigator
AIN SHAMS MATERNAL HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EMLA CREAM 5 mg and LIDOCAINE 1 % in people with Post Operative Pain, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 6 inclusion and 9 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 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 HANY A IBRAHIM, MBBCH (01220034468, DR.HANY_AYAD@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS (time frame: 6 H). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2015.