NCT01303120

Brief Summary

The aim of this study is to compare the efficacy of the analgesic effect of the preoperative femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks in patients after TKA in the immediate postoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable postoperative-pain

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

February 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 21, 2015

Status Verified

February 1, 2011

Enrollment Period

2.6 years

First QC Date

February 20, 2011

Last Update Submit

January 20, 2015

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

  • Efficacy of single short femoral nerve block

    Three days

Study Arms (3)

Femoral Nerve Block

ACTIVE COMPARATOR
Drug: Femoral Nerve Block

Combined Nerve Blocks

ACTIVE COMPARATOR
Drug: Combined nerve blocks

Patient-controlled analgesia

ACTIVE COMPARATOR
Drug: Patient-controlled analgesia

Interventions

Femoral Nerve BlockDRUG

Preoperative Bupivacaine 0.5%, perineurally as single shot

Femoral Nerve Block
Combined nerve blocksDRUG

Preoperative Bupivacaine 0.5%, perineurally as single shot

Combined Nerve Blocks
Patient-controlled analgesiaDRUG

Patient controlled analgesia with morphine

Patient-controlled analgesia

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Undergoing two TKA
  • Understanding PCA protocol

You may not qualify if:

  • Skin infection near injection site
  • Allergy to local analgesics
  • Peripheral neuropathy
  • Coagulopathy
  • Dementia
  • Proven opioid dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Related Publications (1)

  • Stav A, Reytman L, Sevi R, Stav MY, Powell D, Dor Y, Dudkiewicz M, Bayadse F, Sternberg A, Soudry M. Femoral versus Multiple Nerve Blocks for Analgesia after Total Knee Arthroplasty. Rambam Maimonides Med J. 2017 Jan 30;8(1):e0006. doi: 10.5041/RMMJ.10281.

    PMID: 28178436DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 20, 2011

First Posted

February 24, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 21, 2015

Record last verified: 2011-02

Locations

IL(1)