Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00737542
First received: August 17, 2008
Last updated: November 25, 2009
Last verified: August 2008
  Purpose

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
Pain
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 21, 2014