Effectiveness of Analgesia in Total Knee Arthroplasty

NCT ID: NCT01304212

Last Updated: 2014-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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femoral block

Group Type ACTIVE_COMPARATOR

ropivacaine

Intervention Type DRUG

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)

local infiltration + femoral nerve block

Combination of local infiltration with drugs and femoral nerve block

Group Type EXPERIMENTAL

morphine ,ketorolac

Intervention Type DRUG

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.

several drugs local infiltration

Group Type ACTIVE_COMPARATOR

several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac

Intervention Type DRUG

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

ropivacaine,morphine chloride,epinephrine,ketorolac

Intervention Type DRUG

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

Interventions

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several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac

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

Intervention Type DRUG

ropivacaine,morphine chloride,epinephrine,ketorolac

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

Intervention Type DRUG

ropivacaine

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)

Intervention Type DRUG

morphine ,ketorolac

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jose Antonio Bernia Gil

OTHER

Sponsor Role lead

Responsible Party

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Jose Antonio Bernia Gil

PhD,MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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José Antonio Bernia Gil, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari de Terrassa

Locations

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Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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ATR-2011

Identifier Type: -

Identifier Source: org_study_id

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