Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine

NCT ID: NCT02274974

Last Updated: 2015-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-04-30

Brief Summary

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Study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain.

Detailed Description

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assessment of adding of epinephrine to lidocaine as local infiltrator to post-caesarean section wound in prolongation of its anaesthetic effect.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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lidocaine

20 ml of 2% lidocaine.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

•The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine.

lidocaine and epinephrine.

20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000. I.e.: by adding 1/4 from ampoule of adrenaline 1mg./1ml to bottle of lidocaine Hydrochloric acid (HCL) 2% 50 ml(20mg/ml).

Group Type EXPERIMENTAL

lidocaine and Epinephrine

Intervention Type DRUG

The wound of C.S will be infiltrated before closure of the skin, with 20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000.

Interventions

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Lidocaine

•The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine.

Intervention Type DRUG

lidocaine and Epinephrine

The wound of C.S will be infiltrated before closure of the skin, with 20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000.

Intervention Type DRUG

Other Intervention Names

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local anaesthetic agent. local anaesthetic agent.

Eligibility Criteria

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Inclusion Criteria

* Women undergoing caesarean delivery under General anesthesia for various indications.
* Women refuse spinal anesthesia.

Exclusion Criteria

* Known or suspected sensitivity to local anesthesia.
* Medical disorders induced by pregnancy (Pre-eclamptic toxemia, gestational diabetes mellitus, Hepatic diseases, homeostatic disorder)
* Medical disorders aggravated by pregnancy (cardiovascular disease, pulmonary disease, renal disease, neurological disease, metabolic or infectious diseases).
* Women who hemo-dynamically unstable.
* Lack of adequate verbal communication.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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AMR HELMY YEHIA

Lecturer in Obstetrics and Gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr H Yhia, M.D, MRCOG

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Maternity Hospital(AinShamsMH)

Locations

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Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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AbdElRhman G Ali,cairo,egypt,Post-Caerarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine.

Reference Type BACKGROUND

Other Identifiers

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local infilteration of C.S

Identifier Type: -

Identifier Source: org_study_id

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