MedDataX Logo

Adductor Canal Block and Arthroscopic Knee Surgery, High Pain Responders

NCT ID: NCT02001662

Last Updated: 2013-12-06

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthroscopic Knee Surgery

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Minor arthroscopic knee surgery including ACL-reconstruction (hamstrins graft) High pain responders Adductore Canal Block Analgesics Ultrasound guided nerve block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Intervention group, block no. 1 - Ropivacain

Intervention Type PROCEDURE

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

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)

Group Type SHAM_COMPARATOR

Control group: 1. block - saline

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention group, block no. 1 - Ropivacain

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

Intervention Type PROCEDURE

Control group: 1. block - saline

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Malene Espelund

MD,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Malene Espelund, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital, University of Copenhagen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Amager Hospital, University of Copenhagen, Denmark

Copenhagen, Copenhagen, Amager, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-000663-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-3-2013-039

Identifier Type: OTHER

Identifier Source: secondary_id

SM3-ME-13

Identifier Type: -

Identifier Source: org_study_id