NCT03971708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 17, 2022

Status Verified

June 1, 2020

Enrollment Period

5.5 years

First QC Date

May 29, 2019

Last Update Submit

May 16, 2022

Conditions

Nephrectomy

Keywords

LidocaineTAP blocknephrectomyacute pain

Outcome Measures

Primary Outcomes (1)

  • Analgesic consumption

    The amount of morphine equivalent consumption in the first 24 hours post-operatively

    first 24 hours

Secondary Outcomes (2)

  • Analgesic consumption

    4, 12, 36, 48, 72 hours

  • Pain score

    4, 12, 24, 36, 48, 72 hours

Study Arms (2)

Ropivacaine

OTHER

This is the control where patients will receive ropivacaine via the TAP block infusion post-operatively.

Drug: Ropivacaine

Lidocaine

ACTIVE COMPARATOR

This is the study arm where patients will receive lidocaine via the TAP block infusion post-operatively.

Drug: Lidocaine

Interventions

LidocaineDRUG

Local anesthetic

Also known as: Lignocaine
Lidocaine
RopivacaineDRUG

Local anesthetic

Ropivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

Location

MeSH Terms

Conditions

Acute Pain

Interventions

LidocaineRopivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 3, 2019

Study Start

June 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 17, 2022

Record last verified: 2020-06

Locations

CA(1)