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

Ain Shams Maternity Hospital

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: lidocaine and Epinephrine; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02274974

local infilteration of C.S

Details and patient eligibility

About

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

Full description

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

Enrollment: 160 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

lidocaine

Active Comparator group

Description:

20 ml of 2% lidocaine.

Treatment:

Drug: Lidocaine

lidocaine and epinephrine.

Experimental group

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).

Treatment:

Drug: lidocaine and Epinephrine