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Completed

NCT Number: NCT06225323

Effect of Lidocaine Infusion on Neuraxial Opioid-induced Pruritus After Cesarean Section

The aim of this study is to assess the efficacy and potency of lidocaine infusion as a preventive measure on pruritus response after injection of 200 micro gram morphine with bupivacaine subarachnoid block, spinal anesthesia, in cesarean section.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University

Aswān, 81511, Egypt

About this study

Neuraxial opioids (NO) are one of the most widely used methods for postpartum analgesia, for cesarean section analgesia, and many other surgical procedures.

The pruritus induced by NO is an unpleasant, subjective, and irritating sensation that causes scratching response.

Pruritus begins shortly after anesthesia, with the onset depending on the type, route and dosage of opioid used. Pruritus invoked by lipid-soluble opioids such as fentanyl and sufentanil is of shorter duration, and the use of the minimum or small dose from opioids in addition of local anesthetics seems to decrease the prevalence and the severity of itching. Pruritus invoked by intrathecal morphine is of longer duration and is difficult to treat. Intrathecal administration, of opioids reach peak concentrations in the cerebrospinal fluid almost immediately. ]. But, after epidural administration, there is a delay in the rise to peak concentration (10-20 min with fentanyl and 1-4 h with morphine).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 20 to 40 years.
  • Weight from 50 to 90 kg.
  • Women undergoing Cesarean section.

Exclusion criteria

  • Patient with known allergies to lidocaine.
  • Preexisting pruritus.
  • Coexisting skin disorders.
  • Contraindications to spinal anesthesia.
  • Preeclampsia.
  • Eclampsia.
  • Major systemic diseases.
  • Refusal to participate.
  • Uses of any current drugs have potential effects on post-operative itching as steroidal ,nonsteroidal ,ondanstern, propofol, midazolam during study period.

Treatment and study plan

Lidocaine

Drug

Patients will receive Lidocaine infusion for 6 hours. After cord clamping and according to ideal body calculate the bolus dose 1.5 mg/kg of lidocaine 1% and complete the dose by normal saline to 20 ml total volume will be given in 10 min.

The infusion dose 1.5 mg/kg/hour of lidocaine 1% for 6 hours in automated syringe pump (aquavesar fixed variable rate 100ml volume) 100 ml then follow up without infusion up to 24 hours.

Saline

Other

Patients will receive normal saline infusion for 6 hours. After cord clamping 20 ml total volume normal saline will be given in 10 min.

The infusion dose 1.5 mg/kg/hour of normal saline for 6 hours in automated syringe pump (aquavesar fixed variable rate 100ml volume) 100 ml then follow up without infusion up to 24 hours.

Primary outcomes

  1. The incidence of pruritis

    Time frame: 24 hours postoperatively

    The incidence of pruritis will be classifies as moderate (affecting a larger area, such as face and arms or face and anterior surface of thorax, but not disturbing the patient, and therefore not requiring treatment) , severe (extensive or generalized, often disturbing the patient and may need treatment)or very sever(disturbing the patient and treatment was indicated).

Secondary outcomes

  1. The severity of pruritis

    Time frame: 24 hours postoperatively

    The severity of pruritis will be assessed using qualitative scales (Pruritus Severity Scale)such as none, mild, moderate, severe or very sever pruritus.

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Official study title

Effect of Lidocaine Infusion on Neuraxial Opioid-induced Pruritus After Cesarean Section Double-blinded, Randomized Control Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2024
Registry last updated
Jul 31, 2024

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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