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

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

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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