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Completed

NCT Number: NCT02274974

Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine

Study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Wounds and Injuries

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;

Cairo, 11511, Egypt

About this study

assessment of adding of epinephrine to lidocaine as local infiltrator to post-caesarean section wound in prolongation of its anaesthetic effect.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women undergoing caesarean delivery under General anesthesia for various indications.
  • Women refuse spinal anesthesia.

Exclusion criteria

  • Known or suspected sensitivity to local anesthesia.
  • Medical disorders induced by pregnancy (Pre-eclamptic toxemia, gestational diabetes mellitus, Hepatic diseases, homeostatic disorder)
  • Medical disorders aggravated by pregnancy (cardiovascular disease, pulmonary disease, renal disease, neurological disease, metabolic or infectious diseases).
  • Women who hemo-dynamically unstable.
  • Lack of adequate verbal communication.

Treatment and study plan

Lidocaine

Drug

•The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine.

Other names: local anaesthetic agent.

lidocaine and Epinephrine

Drug

The wound of C.S will be infiltrated before closure of the skin, with 20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000.

Other names: local anaesthetic agent.

Primary outcomes

  1. Timing of first analgesic request.

    Time frame: 24 hours

Secondary outcomes

  1. Duration of cesarean section

    Time frame: 30 min to 90 min

  2. Onset of breast breastfeeding

    Time frame: 24 hours

  3. Onset of mobilization

    Time frame: 24 hours

    first time patient start moving after the section

  4. Duration of hospital stay

    Time frame: 24 hours to 48 hours

  5. Side effects of local infiltration of lidocaine and epinephrine

    Time frame: 7 days

  6. Postoperative pyrexia

    Time frame: 24 hours

    <38°c

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;Randomized Controlled Trial.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 27, 2014
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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