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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02549105
Enrollment
80
Registered
2015-09-15
Start date
2014-10-31
Completion date
2015-12-31
Last updated
2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

EMLA CREAM, LIDOCAINE INFILTERATION, PAIN RELIEF

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.

Interventions

DRUGEMLA CREAM 5 mg

EMLA CREAM APPLICATION FOR WOUND AFTER CS

DRUGLIDOCAINE 1 %

LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS

Sponsors

Ain Shams University
CollaboratorOTHER
Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS6 H

Secondary

MeasureTime frame
POSTOPERATIVE PAIN ACCORDING TO VAS24 H

Countries

Egypt

Contacts

Primary ContactHANY A IBRAHIM, MBBCH
DR.HANY_AYAD@YAHOO.COM01220034468
Backup ContactAHMED M MAMDOUH, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026