Post-Caesarean Section Incisional Infiltration With Lidoc... | NCT02274974

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

NCT02274974

Sponsor

Ain Shams Maternity Hospital

Status

Completed

Last Update Posted

Jun 25, 2015Estimated

Enrollment

160Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Lidocaine
lidocaine and Epinephrine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Oct 21, 2014

First Submission Date that Met QC Criteria

Oct 23, 2014

First Posted Date

Oct 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2015

Last Update Posted Date

Jun 25, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

AMR HELMY YEHIA, Lecturer in Obstetrics and Gynaecology, Ain Shams Maternity HospitalPrincipal Investigator

Lead Sponsor

Ain Shams Maternity HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lidocaine	Active Comparator	20 ml of 2% lidocaine.	Drug: Lidocaine
lidocaine and epinephrine.	Experimental	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).	Drug: lidocaine and Epinephrine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine	Drug	•The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine.	lidocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Timing of first analgesic request.		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Duration of cesarean section		30 min to 90 min
Onset of breast breastfeeding		24 hours
Onset of mobilization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amr H Yhia, M.D, MRCOG	Ain Shams Maternity Hospital(AinShamsMH)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;		Cairo		11511	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	AbdElRhman G Ali,cairo,egypt,Post-Caerarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine.

ID	Term
D010149	Pain, Postoperative
D000072836	Surgical Wound

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814