The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section

This study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. One hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also examine possible effect of this infiltration of parameters of wound heeling and scar formation, six weeks post partum.

Study Overview

• Status: Unknown
• Conditions: Pain Relief
• Intervention / Treatment: Drug: Local, pre-incisional injection of 20 ml 1% xylocaine

Detailed Description

Among all other abdominal operations cesarean section is unique in two aspects. First, the requirement for rapid and as painless as possible recovery is not only important for the general good reasons, but there is the newborn baby, who needs maternal care. Second, in many cases the operation recurs in the same site, which may involve higher level of post operative pain.

Application of local anesthetics to the incision site have been tried for abdominal operation in several forms, ranging from pre-incision injection (1-6) through post incision injection (7 ) to indwelling catheter for protracted instillation (8-9). Where tried, these methods mostly contributed to the reduction of post operative pain and patients' satisfaction, although there is no consensus as to its efficacy. Yet, local, pre-incision injection of local anesthetics has not been tested for cesarean section.

The above not withstanding, it has been proposed that local infiltration of tissue with xylocaine may interfere with wound healing (10-11). Others suggested possible benefit due to antimicrobial activity (12) Conversely, Al- Asfour et al. (13) found no effect of topical oral application of xylocaine on experimental wounds in rabbits. Interestingly, Drucker et al. found that less collagen was deposited in healing wounds that were infiltrated with xylocaine prior to incision, while the strength of the scar was not affected (14-15).

Our proposed study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. It will also examine possible effect of this infiltration of parameters of wound heeling and scar formation.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Poriya, Israel
    • Recruiting
    • Department of Obstetrics & Gynecology, Baruch Padeh Medical Center
    • Principal Investigator: Izhar Ben-Shlomo, MD
    • Contact: Izhar Ben-Shlomo, MD; Phone Number: 972-50-6268024; Email: izharbs@netvision.net.il
    • Contact: Aviva Peleg, MSc; Phone Number: 972-50-6267521; Email: apeleg@poria.health.gov.il
    • Sub-Investigator: Nimrod Weitzman, MD
    • Sub-Investigator: Dmitri Chuyun, MD
    • Sub-Investigator: Moshe Ben-Ami, MD, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Candidates for non-emergency cesarean section

Exclusion Criteria:

• Emergency cesarean section
• Known or suspected sensitivity to local anesthetics
• Pre-eclamptic toxemia
• Deranged liver function
• Deranged hemostasis
• Lack of adequate verbal communication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xylocaine; Participants will receive local injection of 20 ml 1% Xylocaine to the skin incision site	Drug: Local, pre-incisional injection of 20 ml 1% xylocaine; Local, pre-incisional injection of 20 ml 1% xylocaine
Placebo Comparator: Controls; Participants will receive injection of 0.9% NaCl 20 ml to the incision site	Drug: Local, pre-incisional injection of 20 ml 1% xylocaine; Local, pre-incisional injection of 20 ml 1% xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Level of post operative pain on a visual analog scale	Up to 48 hours postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Appearance of operative scar, compared to previous scar	6-8 weeks

Collaborators and Investigators

• Sponsor: The Baruch Padeh Medical Center, Poriya
• Investigators: Principal Investigator: Izhar Ben-Shlomo, MD, Department of Obstetrics & Gynecology, Baruch Padeh Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: June 4, 2009
• First Submitted That Met QC Criteria: June 4, 2009
• First Posted (Estimate): June 5, 2009

Study Record Updates

• Last Update Posted (Estimate): August 25, 2009
• Last Update Submitted That Met QC Criteria: August 23, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Xylocaine; Post operative pain; Scar quality; Casarean section
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Xylocaine CS Scar.CTIL