Adductor Canal Block and Arthroscopic Knee Surgery, High Pain Responders

December 5, 2013 updated by: Malene Espelund, Glostrup University Hospital, Copenhagen

The Analgesic Efficacy of the Adductor Canal Blockade in High Pain Responders After Arthroscopic Knee Surgery - a Randomized Clinical Trial

The investigators want to explore the analgesic effect of Adductor Canal Blockade (a peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The investigators hypothesize that the nerve block will have an abrupt analgesic effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen, Amager
      • Copenhagen, Copenhagen, Amager, Denmark, 2300
        • Amager Hospital, University of Copenhagen, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Arthroscopic knee surgery, if reconstruction of Anterior Cruciate Ligament only hamstring graft 18-80 years of age BMI 18-40 ASA I-III written Consent

Exclusion Criteria:

Unable to communicate in danish, allergic reactions toward any study medication pregnancy alcohol/drug abuse daily opioid consumption scin infection (injection site)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group, block no. 1 - Ropivacain

Adductor-Canal-Block no.1: 30mL ropivacaine (7.5 mg/ml) when postoperative VAS-score is > 40mm (on a 0-100 mm VAS-scale) during a 45 degree active flexion of the knee.

Adductor-Canal-Block no.2: after 45 min (t45) - 30mL isotonic saline.
Procedure: Intervention group, block no. 1 - Ropivacain
Intervention group: 1. block ropivacaine - 2. block saline
Sham Comparator: Control group, block no. 1 - saline

Adductor-Canal-Block no.1: 30mL isotonic saline when postoperative VAS-score is above 40mm (on a 0-100 mm VAS-scale) during a 45 degree active flexion of the knee.

Adductor-Canal-Block no.2: after 45 min (t45) - 30mL ropivacaine (7.5 mg/ml)
Procedure: Control group: 1. block - saline
Control group: 1. block saline - 2. block ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score during 45 degree flexion of the knee
Time Frame: 45 minutes after nerve block
Pain score during flexion of the knee 45 min. after nerve block
45 minutes after nerve block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 0-90 min. after first nerveblock
pain score at rest: time 0,15,30,45,60,75,90 min. after first nerve block pain score during flexion of the knee: time 0,15,30,45,60,75,90 min. after first nerve block pain score during mobilisation (5m walk): 45 and 90 min after nerve block
0-90 min. after first nerveblock
muscle strength
Time Frame: 45 and 90 min after nerve block
patients accesses muscle strength during walk
45 and 90 min after nerve block
Opioid consumption
Time Frame: 0-90 min after nerve block
0-90 min after nerve block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Malene Espelund, MD, Glostrup University Hospital, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

December 4, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

December 6, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SM3-ME-13
  • 2013-000663-83 (EudraCT Number)
  • H-3-2013-039 (Other Identifier: Regional Ethics Committee, Capital region of Denmark)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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