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NCT00737542 Clinical Trial

Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

Pain 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.

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00737542
Other study ID # sor470408CTIL
Secondary ID
Status Unknown status
Phase N/A
First received August 17, 2008
Last updated November 25, 2009

Study information
Verified date August 2008
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Unknown status
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lidocaine

• NACL 0.9%

Locations
Country Name City State
Israel Division of Obstetrics and Gynecology - Soroka University Medical Center Beer-Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

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