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

A

Aswan University

Status

Enrolling

Conditions

Neuraxial Opioid
Cesarean Section
Lidocaine Infusion
Pruritus

Treatments

Other: Saline
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06225323
Aswu/668/10/22

Details and patient eligibility

About

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.

Full 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).

Enrollment

160 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 2 patient groups, including a placebo group

Lidocaine group
Experimental group
Description:
Patients will receive Lidocaine infusion for 6 hours
Treatment:
Drug: Lidocaine
Control group
Placebo Comparator group
Description:
Patients will receive normal saline infusion for 6 hours
Treatment:
Other: Saline

Trial contacts and locations

1

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Central trial contact

Ayman M Eldemrdash, MD

Data sourced from clinicaltrials.gov

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