Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

Not Applicable

• Conditions: Pain; Cesarean Delivery
• Interventions: Drug: NACL 0.9%; Drug: lidocaine

• Registration Number: NCT00737542
• Lead Sponsor: Soroka University Medical Center

Brief Summary

The objective of this prospective, double-blinded, placebo-controlled, randomized study is to evaluate the impact of preemptive analgesia using incisional site infiltration of lidocaine as compared to saline solution on post operative pain control in women undergoing cesarean deliveries.

Detailed Description

The studied population would be based on women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision.

Prior to each operation, the surgeon will be provided with a syringe containing a 20 mL solution of 1% lidocaine or 0.9% sodium chloride, which will be injected subcutaneously to the incisional site region after anesthesia and before the beginning of the surgery.

After the operation the conventional post cesarean analgesic regime will be used and recorded for all women.

The self-report of pain will be assessed by the patient using a validated visual analog scale, as instructed by the nursing staff.

The patient's mark will be used as a numerical index of pain intensity. The reports will be taken by the patients in intervals of 4 hours for 48 hours after the operation. In addition, analgesic requirements of the patient will be monitored and recorded by the nursing staff and used for comparison between the two study group

Study Timeline

• Status Verified: 2008-08
• Study First Submitted: 2008-08-17
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Last Update Submitted: 2009-11-25
• Last Update Posted: 2009-11-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision.

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Exclusion Criteria

• More than two previous cesarean deliveries
• Other abdominal operations in the past
• Morbid obesity
• Diabetes mellitus, neurological diseases, systemic vascular disease.
• Mental disability
• Lidocaine sensitivity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	NACL 0.9%	-
B	lidocaine	-

Trial Locations

Locations (1)

Division of Obstetrics and Gynecology - Soroka University Medical Center; 🇮🇱 Beer-Sheva, Israel