Systemic Effects of Lidocaine Infusion for TAP Block Catheter

Nephrectomy Clinical Trial

Official title:

Investigating Systemic Effects of Lidocaine Infusion for Transversus Abdominis Plane (TAP) Block Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971708
• Other study ID #: Pro00054477
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrectomy

Intervention

Drug:
• Lidocaine
Local anesthetic
• Ropivacaine
Local anesthetic

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic consumption	The amount of morphine equivalent consumption in the first 24 hours post-operatively	first 24 hours
Secondary	Analgesic consumption	The amount of morphine equivalent consumption 4 hours, 12 hours, 36 hours, 48 hours, and 72 hours post-operatively	4, 12, 36, 48, 72 hours
Secondary	Pain score	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	4, 12, 24, 36, 48, 72 hours