NCT01911949

Brief Summary

Hip replacement surgery is one of the most common elective surgeries in Canada and with this surgery, there is considerable pain after the operation. By decreasing the amount of pain after surgery, the patients may be able to move and walk quicker, resulting in easier physiotherapy sessions, shorter hospital stays and may help to avoid adverse outcomes like nausea and vomiting and being overly sedated. By using ultrasound guided femoral nerve block, it may be an alternative for pain management with minimal side effects for patients having hip replacement surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

July 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
3.4 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

July 26, 2013

Last Update Submit

March 20, 2018

Conditions

Post Surgical Pain

Keywords

femoral nerve blockultrasound guidedtotal hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is number of patients recruited per week and we hope to recruit 2 patients per week.

    Three months

Secondary Outcomes (4)

  • Number of eligible patients consenting to participate.

    Three months

  • Number of patients participating that were randomized and received the study intervention.

    Three months

  • Completion of study data collection forms

    Three months

  • Incidence of respiratory depression and seizures in participating subjects

    Three months

Study Arms (2)

Single shot femoral nerve block

EXPERIMENTAL

Ultrasound guided Femoral Nerve Block-40ml of bupivacaine 0.5% with epinephrine

Drug: Single shot femoral nerve block

Placebo femoral nerve block

PLACEBO COMPARATOR

Sterile normal saline solution

Drug: Single shot femoral nerve block

Interventions

Single shot femoral nerve blockDRUG

Nerve block in lingual crease using ultrasound guidance

Also known as: Femoral Nerve Block with 40ml bupivacaine plus 0.5% epinephrine
Placebo femoral nerve blockSingle shot femoral nerve block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years or older undergoing unilateral hip arthroplasty.
  • Patient capable to complete informed consent.

You may not qualify if:

  • Pediatric population.
  • Inability to complete informed consent.
  • Patient refusal.
  • Contraindication for regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders, local or systemic infection, local anesthesia allergy.
  • Presence of neuromuscular deficit including diabetic peripheral neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Heathcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

  • Rothwell MP, Pearson D, Hunter JD, Mitchell PA, Graham-Woollard T, Goodwin L, Dunn G. Oral oxycodone offers equivalent analgesia to intravenous patient-controlled analgesia after total hip replacement: a randomized, single-centre, non-blinded, non-inferiority study. Br J Anaesth. 2011 Jun;106(6):865-72. doi: 10.1093/bja/aer084. Epub 2011 Apr 13.

    PMID: 21490024BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineEpinephrine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Mauricio Forero, MD

    St. Joseph's Healthcare Hamilton

    PRINCIPAL INVESTIGATOR

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

July 26, 2013

First Posted

July 30, 2013

Study Start

January 1, 2017

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

CA(1)