Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

NCT ID: NCT00737542

Last Updated: 2009-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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

Conditions

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Pain Cesarean Delivery

Keywords

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management post

Study Groups

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A

Group Type PLACEBO_COMPARATOR

NACL 0.9%

Intervention Type DRUG

B

Group Type EXPERIMENTAL

lidocaine

Intervention Type DRUG

Interventions

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lidocaine

Intervention Type DRUG

NACL 0.9%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Soroka University Medical Center

Locations

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Division of Obstetrics and Gynecology - Soroka University Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Roy S Kessous, MD

Role: primary

Other Identifiers

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sor470408CTIL

Identifier Type: -

Identifier Source: org_study_id