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Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

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ClinicalTrials.gov Identifier: NCT00737542
Recruitment Status : Unknown
Verified August 2008 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2008
Last Update Posted : November 26, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pain Cesarean Delivery Drug: lidocaine Drug: NACL 0.9% Not Applicable

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 Type : Interventional  (Clinical Trial)
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 the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: A Drug: NACL 0.9%
Experimental: B Drug: lidocaine




Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737542


Locations
Israel
Division of Obstetrics and Gynecology - Soroka University Medical Center Not yet recruiting
Beer-Sheva, Israel, Box 151
Contact: Roy S Kessous, MD    972-4722013    royke@clalit.org.il   
Principal Investigator: Roy Kessous, MD         
Sponsors and Collaborators
Soroka University Medical Center

Responsible Party: Roy Kessous Md., Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00737542     History of Changes
Other Study ID Numbers: sor470408CTIL
First Posted: August 19, 2008    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: August 2008

Keywords provided by Soroka University Medical Center:
management
post

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
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