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Trials / Completed

CompletedNCT06383845

Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy.

Comparison of Erector Spinae Plane Block and Intravenous Lidocaine for Chronic Pain Post Mastectomy: a Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
University Tunis El Manar · Academic / Other
Sex
Female
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP). For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery. For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction. Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery.

Detailed description

Patients undergoing breast surgery with lymph node dissection were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP). For Lido-IV group, patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 2 mg/kg/h till the end of surgery. For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction with injection of 30 ml of Ropivacaine 3.75%. For both group, persistant pain post mastectomy was assessed by Item 5 of BPI score at 1, 3 and 6 months post surgery.

Conditions

Interventions

TypeNameDescription
DRUGLido-IVIntravenous Lidocaine dose loading than a continuous infusion
DRUGESP Blockultrasound guided block with injection of Ropivacaine

Timeline

Start date
2023-01-01
Primary completion
2024-01-31
Completion
2025-09-30
First posted
2024-04-25
Last updated
2025-11-18

Locations

1 site across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT06383845. Inclusion in this directory is not an endorsement.

Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy. (NCT06383845) · Clinical Trials Directory