NCT02001662

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2013

Shorter than P25 for phase_4

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

April 9, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2013

Enrollment Period

6 months

First QC Date

April 9, 2013

Last Update Submit

December 5, 2013

Conditions

Arthroscopic Knee Surgery

Keywords

Minor arthroscopic knee surgery including ACL-reconstruction (hamstrins graft)High pain respondersAdductore Canal BlockAnalgesicsUltrasound guided nerve block

Outcome Measures

Primary Outcomes (1)

  • Pain score during 45 degree flexion of the knee

    Pain score during flexion of the knee 45 min. after nerve block

    45 minutes after nerve block

Secondary Outcomes (3)

  • Pain score

    0-90 min. after first nerveblock

  • muscle strength

    45 and 90 min after nerve block

  • Opioid consumption

    0-90 min after nerve block

Study Arms (2)

Intervention group, block no. 1 - Ropivacain

EXPERIMENTAL

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

Control group, block no. 1 - saline

SHAM COMPARATOR

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

Interventions

Intervention group, block no. 1 - RopivacainPROCEDURE

Intervention group: 1. block ropivacaine - 2. block saline

Intervention group, block no. 1 - Ropivacain
Control group: 1. block - salinePROCEDURE

Control group: 1. block saline - 2. block ropivacaine

Control group, block no. 1 - saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amager Hospital, University of Copenhagen, Denmark

Copenhagen, Copenhagen, Amager, 2300, Denmark

Location

Study Officials

  • Malene Espelund, MD

    Glostrup University Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,

Study Record Dates

First Submitted

April 9, 2013

First Posted

December 5, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 6, 2013

Record last verified: 2013-12

Locations

DK(1)