NCT01304212

Brief Summary

The purpose of this study is to compare the analgesic effectiveness of three techniques: the femoral nerve block, intraarticular infiltration or a combination of both in the control of pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the performance multimodal postoperative pain KA combining two analgesic techniques to obtain better analgesia than when applied separately.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_4 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 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

2.8 years

First QC Date

February 24, 2011

Last Update Submit

August 27, 2014

Conditions

Pain

Keywords

total knee arthroplastyintraarticular infiltrationfemoral block

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    Is measured at the time of starting rehabilitation, postoperatively 48 hours using visual analog scale, numerical and categorical verbal pain scale at 12,24 and 48 hours

    48 hours postoperatively

Study Arms (3)

femoral block

ACTIVE COMPARATOR
Drug: ropivacaine

local infiltration + femoral nerve block

EXPERIMENTAL

Combination of local infiltration with drugs and femoral nerve block

Drug: morphine ,ketorolac

several drugs local infiltration

ACTIVE COMPARATOR
Drug: several drugs: morphine chloride,ropivacaine,epinephrine,ketorolacDrug: ropivacaine,morphine chloride,epinephrine,ketorolac

Interventions

several drugs: morphine chloride,ropivacaine,epinephrine,ketorolacDRUG

This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline

several drugs local infiltration
ropivacaine,morphine chloride,epinephrine,ketorolacDRUG

This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline

several drugs local infiltration
ropivacaineDRUG

The lock is held before starting the operation, viewing with ultrasound and confirmed the femoral nerve with nerve stimulation at an intensity of 0.5 mA and a frequency of 2 Hz Pajunk 50mm needle, patellar flexion. It be administered 30ml of ropivacaine 0.75% (225mg)

femoral block
morphine ,ketorolacDRUG

ultrasound-assisted femoral nerve block is performed and leaks intraoperatively with a 100 ml solution containing: 5 mg of morphine to 0.1% (5ml) +30 mg of ketorolac (1 ml) +96 ml of 0.9% saline.

local infiltration + femoral nerve block

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • intervention program for total knee arthroplasty
  • ASA I, II, III
  • over 65 years old

You may not qualify if:

  • ASA \> III
  • patients who refuse the realization of technical loco-regional anesthesia
  • presence of coagulopathy or impaired hemostatic function
  • BMI \> 35
  • Serious intraoperative complications
  • patients undergoing bypass and aortic-femoral or femoro popliteal bypass operated leg
  • patients treated for chronic pain diagnosed processes, different knee osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • José Antonio Bernia Gil, MD, PhD

    Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD,MD

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

April 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

ES(1)