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The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

Primary Purpose

Postoperative Pain, Knee Arthroplasty

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Adductor-Canal-Blockade with Ropivacaine

Adductor-Canal-blockade with saline

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Adductor-Canal-Blockade, postoperative pain, US-guided nerve block, revision knee arthroplasty

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Revision Knee Arthroplasty in general anaesthesia
American society of anesthesiologists (ASA) 1-3
BMI 18-40
Written informed consent

Exclusion Criteria:

Can not cooperate to the exam
Do not speak or understand Danish
Drug allergy
Alcohol or drug abuse

Sites / Locations

Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adductor-Canal-Blockade with ropivacaine

Adductor-Canal-blockade with saline

Arm Description

Outcomes

Primary Outcome Measures

Pain during 45 degrees active flexion of the knee

0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.

Secondary Outcome Measures

Pain during 45 degrees active flexion of the knee

0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.

Pain during 45 degrees active flexion of the knee

0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

Pain during rest

0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.

Pain during rest

0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

Total morphine consumption

Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

Postoperative nausea

Nausea scores(0-3)registered at 1,2,4,6 and 8 hours postoperative, calculated as mean value for the interval 1-8 hours postoperative.

Postoperative nausea

Nausea score(0-3)at 24 hours postoperative.

Postoperative vomiting

Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.

Zofran consumption

Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

Sedation

Sedation score (0-3) registered at 1,2,4,6 and 8 hours postoperative, calculated as the mean value for the interval 1-8 hours postoperative.

Sedation

Sedation score (0-3) at 24 hours postoperative.

Full Information

NCT ID

NCT01191593

First Posted

August 30, 2010

Last Updated

August 21, 2013

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01191593

Brief Title

The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

Official Title

The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing pain and morphine consumption after revision knee arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Knee Arthroplasty

Keywords

Adductor-Canal-Blockade, postoperative pain, US-guided nerve block, revision knee arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adductor-Canal-Blockade with ropivacaine

Arm Type

Experimental

Arm Title

Adductor-Canal-blockade with saline

Arm Type

Placebo Comparator

Intervention Type

Procedure

Intervention Name(s)

Adductor-Canal-Blockade with Ropivacaine

Other Intervention Name(s)

Naropine, Postoperative pain, US-guided nerve block

Intervention Description

US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml

Intervention Type

Procedure

Intervention Name(s)

Adductor-Canal-blockade with saline

Other Intervention Name(s)

Placebo block

Intervention Description

US-guided Adductor-Canal-blockade with saline

Primary Outcome Measure Information:

Title

Pain during 45 degrees active flexion of the knee

Description

0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.

Time Frame

4 hours postoperative

Secondary Outcome Measure Information:

Title

Pain during 45 degrees active flexion of the knee

Description

0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.

Time Frame

1-8 hours postoperative

Title

Pain during 45 degrees active flexion of the knee

Description

0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

Time Frame

24 hours postoperative

Title

Pain during rest

Description

0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.

Time Frame

1-8 hours postoperative

Title

Pain during rest

Description

0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

Time Frame

24 hours postoperative

Title

Total morphine consumption

Description

Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

Time Frame

0-24 hours postoperative

Title

Postoperative nausea

Description

Nausea scores(0-3)registered at 1,2,4,6 and 8 hours postoperative, calculated as mean value for the interval 1-8 hours postoperative.

Time Frame

1-8 hours postoperative

Title

Postoperative nausea

Description

Nausea score(0-3)at 24 hours postoperative.

Time Frame

24 hours postoperative

Title

Postoperative vomiting

Description

Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.

Time Frame

0-24 hours postoperative

Title

Zofran consumption

Description

Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

Time Frame

0-24 hours postoperative

Title

Sedation

Description

Sedation score (0-3) registered at 1,2,4,6 and 8 hours postoperative, calculated as the mean value for the interval 1-8 hours postoperative.

Time Frame

1-8 hours postoperative

Title

Sedation

Description

Sedation score (0-3) at 24 hours postoperative.

Time Frame

24 hours postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Revision Knee Arthroplasty in general anaesthesia American society of anesthesiologists (ASA) 1-3 BMI 18-40 Written informed consent Exclusion Criteria: Can not cooperate to the exam Do not speak or understand Danish Drug allergy Alcohol or drug abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pia Jæger, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark

City

Copenhagen

State/Province

København Ø

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

25386752

Citation

Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.

Results Reference

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The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

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