NCT02056145

Brief Summary

Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

February 4, 2014

Last Update Submit

July 1, 2014

Conditions

-Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Use of opioids

    The primary outcome measure will be a consumption of opioids through the Intravenous Patient Controlled Analgesia pump. Those amounts will be measured en documented at the fixed intervals during the first 48 hours post-procedure.

    48 hours

Secondary Outcomes (1)

  • Visual analog scale (VAS) scores (0-10)

    48 hours

Study Arms (3)

Group 1

PLACEBO COMPARATOR

Group 1 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.9% saline solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 30 ml saline solution 0.9%.

Procedure: LFCNBProcedure: FNB

Group 2

ACTIVE COMPARATOR

Group 2 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 20 cc 0.25% bupivacaine solution en 10 cc saline solution 0.9%.

Procedure: LFCNBProcedure: FNB

Group 3

ACTIVE COMPARATOR

Group 3 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.25% bupivacaine solution for lateral femoral cutaneous block, for a total of 30 cc of 0.25% bupivacaine solution.

Procedure: LFCNBProcedure: FNB

Interventions

LFCNBPROCEDURE

LFCNB - Normal Saline solution 10 cc

Group 1Group 2
FNBPROCEDURE

FNB - Normal saline solution 10 cc

Group 1

Eligibility Criteria

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

You may qualify if:

  • Primary hip arthroplasty with posterolateral approach.

You may not qualify if:

  • Known allergy to levobupivacaine and / or piritramide
  • Known neurological disorders or peripheral neuropathies
  • Existing drug or alcohol abuse
  • Chronic use of pain medication (\> started 3 months ago) not related to the hip suffering
  • Coagulopathy (international normalized ratio) \> 1.4
  • Thrombocytopenia \<70,000 platelets,
  • Dementia
  • Pregnancy
  • Local infection hip
  • Hepatic and / or renal impairment
  • BMI\> 45.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Sint Augustinus

Wilrijk, Antwerpen, 2610, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sultan TEMURZIEV, MD

    Department of Anesthesiology, Antwerp University Hospital

    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
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ethische Comité UZ Antwerpen

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 5, 2014

Study Start

October 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

BE(1)