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Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Soroka University Medical Center Identifier:
First received: August 17, 2008
Last updated: November 25, 2009
Last verified: August 2008
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.

Condition Intervention
Cesarean Delivery
Drug: lidocaine
Drug: NACL 0.9%

Study Type: Interventional
Official Title: A Prospective Randomized Double-blind, Placebo-controlled Study of the Effect of Preoperative Analgesia With Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

Resource links provided by NLM:

Further study details as provided by Soroka University Medical Center:

Arms Assigned Interventions
Placebo Comparator: A Drug: NACL 0.9%
Experimental: B Drug: lidocaine

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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00737542

Division of Obstetrics and Gynecology - Soroka University Medical Center Not yet recruiting
Beer-Sheva, Israel, Box 151
Contact: Roy S Kessous, MD    972-4722013   
Principal Investigator: Roy Kessous, MD         
Sponsors and Collaborators
Soroka University Medical Center
  More Information

Responsible Party: Roy Kessous Md., Soroka University Medical Center Identifier: NCT00737542     History of Changes
Other Study ID Numbers: sor470408CTIL
Study First Received: August 17, 2008
Last Updated: November 25, 2009

Keywords provided by Soroka University Medical Center:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017