Clinical trial NCT02549105: Lidocaine-Prilocaine Cream (EMLA) Topical Application Versus Wound Infiltration With Lidocaine After Cesarean Section
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: EMLA CREAM
LIDOCAINE INFILTERATION
PAIN RELIEF
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2015-09-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS
timeFrame: 6 H
Secondary outcomes:
measure: POSTOPERATIVE PAIN ACCORDING TO VAS
timeFrame: 24 H
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university Maternity hospital
state: Abbasya
Study officials:
affiliation: AIN SHAMS MATERNAL HOSPITAL
name: MAGED R ABO SAEDA, MD
role: PRINCIPAL_INVESTIGATOR
References: