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

Primary Purpose

Pain, Postoperative

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Lidocaine

lidocaine and Epinephrine

About this trial

This is an interventional screening trial for Pain, Postoperative focused on measuring incisional, infiltration, cs, lidocaine, epinephrine, Adverse Reaction to Topical or Infiltrative Lidocaine

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

lidocaine

lidocaine and epinephrine.

Arm Description

20 ml of 2% lidocaine.

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).

Outcomes

Primary Outcome Measures

Timing of first analgesic request.

Secondary Outcome Measures

Duration of cesarean section

Onset of breast breastfeeding

Onset of mobilization

first time patient start moving after the section

Duration of hospital stay

Side effects of local infiltration of lidocaine and epinephrine

Postoperative pyrexia

<38°c

Full Information

NCT ID

NCT02274974

First Posted

October 21, 2014

Last Updated

June 24, 2015

Sponsor

Ain Shams Maternity Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02274974

Brief Title

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

Official Title

Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

Keywords

incisional, infiltration, cs, lidocaine, epinephrine, Adverse Reaction to Topical or Infiltrative Lidocaine

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

lidocaine

Arm Type

Active Comparator

Arm Description

20 ml of 2% lidocaine.

Arm Title

lidocaine and epinephrine.

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Other Intervention Name(s)

local anaesthetic agent.

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

lidocaine and Epinephrine

Other Intervention Name(s)

local anaesthetic agent.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Timing of first analgesic request.

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Duration of cesarean section

Time Frame

30 min to 90 min

Title

Onset of breast breastfeeding

Time Frame

24 hours

Title

Onset of mobilization

Description

first time patient start moving after the section

Time Frame

24 hours

Title

Duration of hospital stay

Time Frame

24 hours to 48 hours

Title

Side effects of local infiltration of lidocaine and epinephrine

Time Frame

7 days

Title

Postoperative pyrexia

Description

<38°c

Time Frame

24 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amr H Yhia, M.D, MRCOG

Organizational Affiliation

Ain Shams Maternity Hospital(AinShamsMH)

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Cairo

ZIP/Postal Code

11511

Country

Egypt

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

background

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

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