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

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Lidocaine; Drug: lidocaine and Epinephrine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Principal Investigator: Amr H Yhia, M.D, MRCOG, Ain Shams Maternity Hospital(AinShamsMH)

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: lidocaine; epinephrine; infiltration; incisional; cs; Adverse Reaction to Topical or Infiltrative Lidocaine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Anesthetics; Lidocaine; Anesthetics, Local; Epinephrine
• Other Study ID Numbers: local infilteration of C.S