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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274974
• Other study ID #: local infilteration of C.S
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2014
• Last updated: June 24, 2015
• Start date: August 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Egypt	Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timing of first analgesic request.		24 hours	Yes
Secondary	Duration of cesarean section		30 min to 90 min	No
Secondary	Onset of breast breastfeeding		24 hours	No
Secondary	Onset of mobilization	first time patient start moving after the section	24 hours	No
Secondary	Duration of hospital stay		24 hours to 48 hours	No
Secondary	Side effects of local infiltration of lidocaine and epinephrine		7 days	No
Secondary	Postoperative pyrexia	<38°c	24 hours	No