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

Sponsor

Ain Shams Maternity Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02274974

Collaborator

(none)

160

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Lidocaine Drug: lidocaine and Epinephrine	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: lidocaine 20 ml of 2% lidocaine.	Drug: Lidocaine •The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine. Other Names: local anaesthetic agent.
Experimental: 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).	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. Other Names: local anaesthetic agent.

Arm

Intervention/Treatment

Active Comparator: lidocaine

20 ml of 2% lidocaine.

Drug: Lidocaine

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

Other Names:

local anaesthetic agent.

Experimental: 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).

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.

Other Names:

local anaesthetic agent.

Outcome Measures

Primary Outcome Measures

Timing of first analgesic request. [24 hours]

Secondary Outcome Measures

Duration of cesarean section [30 min to 90 min]
Onset of breast breastfeeding [24 hours]
Onset of mobilization [24 hours]
first time patient start moving after the section
Duration of hospital stay [24 hours to 48 hours]
Side effects of local infiltration of lidocaine and epinephrine [7 days]
Postoperative pyrexia [24 hours]
<38°c

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.