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Lidocaine-Prilocaine Cream (EMLA) Topical Application Versus Wound Infiltration With Lidocaine After Cesarean Section

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ClinicalTrials.gov Identifier: NCT02549105
Recruitment Status : Unknown
Verified September 2015 by HANY AYAD IBRAHIM, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
HANY AYAD IBRAHIM, Ain Shams Maternity Hospital

Brief Summary:
A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: EMLA CREAM 5 mg Drug: LIDOCAINE 1 % Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EMLA CREAM
EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS
Drug: EMLA CREAM 5 mg
EMLA CREAM APPLICATION FOR WOUND AFTER CS
Other Name: EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25

Active Comparator: LIDOCAINE INFILTERATION
LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS
Drug: LIDOCAINE 1 %
LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS
Other Name: XYLOCAINE




Primary Outcome Measures :
  1. TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS [ Time Frame: 6 H ]

Secondary Outcome Measures :
  1. POSTOPERATIVE PAIN ACCORDING TO VAS [ Time Frame: 24 H ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 18 and 40 years.
  2. Patient American Society of Anesthesiologists physical status І or П.
  3. Gestational age of pregnancy of 37w or more.
  4. Patient have no previous section or have 1or 2 previous sections.
  5. Patient having no medical disorders.
  6. Patient with no obstetrical complications.

Exclusion Criteria:

  1. age below18 or above 40.
  2. Women American Society of Anesthesiologists physical status ш or more.
  3. Women having more than 2 previous cesarean section.
  4. Women receive cardio vascular drugs or having history of cardio vascular disease.
  5. Women with Medical disorders with pregnancy as diabetes milletus.
  6. Women having obstetrical complications as antepartum hemorrhage, pre-eclampsia or eclampsia.
  7. Women having metabolic, hormonal, respiratory, renal and hepatic disease.
  8. Women with any severe allergic condition or severe asthma.
  9. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549105


Contacts
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Contact: HANY A IBRAHIM, MBBCH 01220034468 DR.HANY_AYAD@YAHOO.COM
Contact: AHMED M MAMDOUH, MD

Locations
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Egypt
Ain Shams university Maternity hospital Recruiting
Cairo, Abbasya, Egypt, 11821
Contact: Maged R Aboseda, professor    00201069190707    ahmadhassan376@gmail.com   
Sponsors and Collaborators
Ain Shams Maternity Hospital
Ain Shams University
Investigators
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Principal Investigator: MAGED R ABO SAEDA, MD AIN SHAMS MATERNAL HOSPITAL

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Responsible Party: HANY AYAD IBRAHIM, RESIDENT DOCTOR, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02549105     History of Changes
Other Study ID Numbers: Ain Shams MH
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015

Keywords provided by HANY AYAD IBRAHIM, Ain Shams Maternity Hospital:
EMLA CREAM
LIDOCAINE INFILTERATION
PAIN RELIEF

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Prilocaine
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined