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

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02549105
• Other study ID #: Ain Shams MH
• Status: Recruiting
• Phase: Phase 4
• First received: January 21, 2015
• Last updated: September 11, 2015
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Ain Shams Maternity Hospital
• Contact: HANY A IBRAHIM, MBBCH
• Phone: 01220034468
• Email: DR.HANY_AYAD[@]YAHOO.COM
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 40 years.

2. Patient American Society of Anesthesiologists physical status ? or ?.

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 ? 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• EMLA CREAM 5 mg
EMLA CREAM APPLICATION FOR WOUND AFTER CS
• LIDOCAINE 1 %
LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS

Locations

Country	Name	City	State
Egypt	Ain Shams university Maternity hospital	Cairo	Abbasya

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS		6 H	Yes
Secondary	POSTOPERATIVE PAIN ACCORDING TO VAS		24 H	Yes