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Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

S

Soroka University Medical Center

Status

Unknown

Conditions

Cesarean Delivery
Pain

Treatments

Drug: lidocaine
Drug: NACL 0.9%

Study type

Interventional

Funder types

Other

Identifiers

NCT00737542
sor470408CTIL

Details and patient eligibility

About

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.

Full 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

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

A
Placebo Comparator group
Treatment:
Drug: NACL 0.9%
B
Experimental group
Treatment:
Drug: lidocaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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