Systemic Effects of Lidocaine Infusion for TAP Block Catheter

Not Applicable

Completed

• Conditions: Nephrectomy
• Interventions: Drug: Ropivacaine; Drug: Lidocaine

• Registration Number: NCT03971708
• Lead Sponsor: University of Alberta

Brief Summary

Lidocaine is a local anesthetic that is usually used for nerve blocks to sensory/motor blockade. However, lidocaine can also been given intravenously, and it has been shown that this method can be used to help alleviate chronic pain. We wish to investigate if lidocaine is infused via the transversus abdominis plane (TAP) block catheter will exert systemic effect, hence reduce opioid consumption and pain score in patients compared with using local anesthetic such as ropivacaine.

Detailed Description

Following IRB approval and written consents, patients undergoing nephrectomy were randomized into 2 groups: standard 0.2% ropivacaine infusion (control) and 0.4% lidocaine infusion for TAP catheter. The TAP catheters were placed by the surgeons under direct vision at the end of surgery before wound closure. All subjects had a general anesthetic in accordance to the discretion of the anesthesiologist in the operating room. At the end of surgery, all patients received a patient-controlled analgesia (PCA) in recovery for 48 hours. The primary outcome was the total opioid consumption at the first 27 hours post-operatively. The secondary outcomes were the total opioid consumption at 4/12/24/36/48/60 hours after the initiation of local anesthetic infusion, the numerical rating scale (NRS) at rest and on movement at 4/12/24/36/48/60 hours after the initiation of the local anesthetic infusion, the incidence of nausea and vomiting, and adverse effects.

The sample size calculation for this non-inferiority trial is based on our previous retrospective study on TAP in nephrectomy patients. A sample of 80 patients is needed, using a power of 90% with the two-sided significance level of 5%. All parametric data will be analyzed using mean and standard deviation. Non-parametric data will be analyzed using median and interquartile range. Student's t-test or Mann-Whitney U test will be used to compare between groups.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Status Verified: 2020-06
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Elective nephrectomy
• patients consent to study
• ASA I to III

Exclusion Criteria

• Patient refusal
• Allergy to lidocaine,
• Patients with cardiac arrhythmias or on anti-arrhythmics or propranolol
• Wolf-Parkinson White syndrome
• Hepatic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine	This is the control where patients will receive ropivacaine via the TAP block infusion post-operatively.
Lidocaine	Lidocaine	This is the study arm where patients will receive lidocaine via the TAP block infusion post-operatively.

Primary Outcome Measures

Name	Time	Method
Analgesic consumption	first 24 hours	The amount of morphine equivalent consumption in the first 24 hours post-operatively

Secondary Outcome Measures

Name	Time	Method
Analgesic consumption	4, 12, 36, 48, 72 hours	The amount of morphine equivalent consumption 4 hours, 12 hours, 36 hours, 48 hours, and 72 hours post-operatively
Pain score	4, 12, 24, 36, 48, 72 hours	Pain score measured in the form of Numeric Rating Scale at 4 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post-operatively

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada