NCT01522066

Brief Summary

An alternative to general anesthesia - which puts a patient completely to sleep - is regional anesthesia, where local anesthetic is injected under the skin to freeze or 'block' a nerve or set of nerves. This method allows a patient to be awake during surgery and avoids any unpleasant after-effects of general anesthetic. A regional block is normally performed by inserting a needle under the skin so that the needle tip is near the nerve to be blocked, followed by injection of a single shot of enough local anesthetic to block any sensation that the nerve normally provides. Although regional nerve blocks provide pain relief during a surgical procedure, they eventually wear off, occasionally leaving the patient to contend with localized pain in the part of the body that was operated on. In these cases, over-the-counter painkillers like Tylenol or Advil may not be strong enough to completely take away the pain. We believe that, instead of giving a single shot of anesthetic, patients can be fitted with a catheter - a thin, flexible tube - that can be used to deliver one dose of local anesthetic to block the nerve before surgery and which could also be used to deliver a second dose of anesthetic just prior to discharge from the hospital. This way, the patient still only receives one needle poke, but their pain can be better managed following surgery. Our study will compare the post-nerve block pain profiles of individuals who have received a single-shot injection of local anesthetic versus those who have received two doses via the catheter delivery method.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

January 26, 2012

Last Update Submit

March 23, 2020

Conditions

Local AnesthesiaAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain levels

    Pain levels at surgery site following surgery (up to 24 hours post-surgery) will be assessed.

    24 hours following surgery

Secondary Outcomes (1)

  • Patient comfort at home

    Post-operative period (approx. 24 hrs following surgery)

Study Arms (2)

Perineural catheter

EXPERIMENTAL

Local anesthetic will be delivered through an indwelling perineural catheter

Procedure: Perineural catheter

Single-shot block

ACTIVE COMPARATOR

Local anesthetic will be delivered by the conventional, single-shot method.

Procedure: Single-shot block

Interventions

Perineural catheterPROCEDURE

Patients in the experimental group will receive a single dose of local anesthetic though an indwelling catheter both before and after surgery.

Perineural catheter
Single-shot blockPROCEDURE

Patients in the control group will receive a single shot of local anesthetic, in standard fashion, before surgery.

Single-shot block

Eligibility Criteria

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

You may qualify if:

  • Adult (\> 18 yrs)
  • Scheduled for surgery that requires peripheral nerve blockade

You may not qualify if:

  • Failure to provide informed consent
  • Allergy to local anesthetic
  • Neurological pathology and/or deficit in the block region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

  • Ip VH, Tsui BC. The catheter-over-needle assembly facilitates delivery of a second local anesthetic bolus to prolong supraclavicular brachial plexus block without time-consuming catheterization steps: a randomized controlled study. Can J Anaesth. 2013 Jul;60(7):692-9. doi: 10.1007/s12630-013-9951-5. Epub 2013 May 1.

    PMID: 23637033DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ban Tsui, MD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 31, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

CA(1)