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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06225323
Enrollment
136
Registered
2024-01-25
Start date
2024-01-29
Completion date
2024-04-30
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Lidocaine Infusion, Neuraxial Opioid, Pruritus

Brief summary

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.

Detailed description

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).

Interventions

DRUGLidocaine

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.

OTHERSaline

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.

Sponsors

Aswan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of pruritis24 hours postoperativelyThe 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

MeasureTime frameDescription
The severity of pruritis24 hours postoperativelyThe severity of pruritis will be assessed using qualitative scales (Pruritus Severity Scale)such as none, mild, moderate, severe or very sever pruritus.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026