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

Not Applicable

Completed

• Conditions: Neuraxial Opioid; Cesarean Section; Lidocaine Infusion; Pruritus
• Interventions: Other: Saline; Drug: Lidocaine

• Registration Number: NCT06225323
• Lead Sponsor: Aswan University

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).

Study Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-25
• Study Start: 2024-01-29
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline	Patients will receive normal saline infusion for 6 hours
Lidocaine group	Lidocaine	Patients will receive Lidocaine infusion for 6 hours

Primary Outcome Measures

Name	Time	Method
The incidence of pruritis	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 Outcome Measures

Name	Time	Method
The severity of pruritis	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.

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt