Clinical trial

Effect of Lidocaine Infusion on Neuraxial Opioid-induced Pruritus After Cesarean Section Double-blinded, Randomized Control Clinical Trial

Name

Aswu/668/10/22

Description

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.

Trial arms

Trial start

2024-01-29

Estimated PCD

2024-05-01

Trial end

2024-05-01

Status

Recruiting

Treatment

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.

Arms:

Lidocaine group

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.

Arms:

Control group

Size

160

Primary endpoint

The incidence of pruritis

24 hours postoperatively

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

Updated at

2024-01-30

1 organization

1 product

4 indications

Organization

Product

Indication

Indication

Indication

Indication