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

Ain Shams Maternity Hospital

Status and phase: Unknown; Phase 4

Conditions: Post Operative Pain

Treatments: Drug: EMLA CREAM 5 mg; Drug: LIDOCAINE 1 %

Study type: Interventional

Funder types: Other

Identifiers

NCT02549105

Ain Shams MH

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

EMLA CREAM

Active Comparator group

Description:

EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS

Treatment:

Drug: EMLA CREAM 5 mg

LIDOCAINE INFILTERATION

Active Comparator group

Description:

LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS

Treatment:

Drug: LIDOCAINE 1 %