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

NCT06225323 | Completed

• 1 other identifier: Aswu/668/10/22
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Lidocaine Infusion; Neuraxial Opioid; Pruritus; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• The incidence of pruritis

  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).

  24 hours postoperatively

Secondary Outcomes (1)

• The severity of pruritis

  24 hours postoperatively

Study Arms (2)

Lidocaine group

EXPERIMENTAL

Patients will receive Lidocaine infusion for 6 hours

Drug: Lidocaine

Control group

PLACEBO COMPARATOR

Patients will receive normal saline infusion for 6 hours

Other: Saline

Interventions

Lidocaine 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.

Lidocaine group

Saline 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.

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Women undergoing Cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 20 to 40 years.
• Weight from 50 to 90 kg.
• Women undergoing Cesarean section.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University

Aswān, 81511, Egypt

Location

MeSH Terms

Conditions

Pruritus

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 25, 2024
• Study Start: January 29, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)