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

NCT ID: NCT06225323

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2024-04-30

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).

Conditions

Lidocaine Infusion; Neuraxial Opioid; Pruritus; Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine group

Patients will receive Lidocaine infusion for 6 hours

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: 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.

Control group

Patients will receive normal saline infusion for 6 hours

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: 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.

Interventions

Lidocaine

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.

Intervention Type: DRUG

Saline

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Mohamady Eldemrdash

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aswan University

Aswān, , Egypt

Countries

Egypt

Other Identifiers

Aswu/668/10/22

Identifier Type: -

Identifier Source: org_study_id