Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption

NCT ID: NCT02539628

Last Updated: 2017-04-28

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

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-09-30

Brief Summary

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

The investigators believe sufficient spread to all nerves within the adductor canal-and thereby sufficient analgesia-can only be obtained by bolus injections and not by continuous infusions via a catheter. The aim of the study is to investigate whether an adductor canal block performed as repeated intermittent boluses provides superior pain relief to continuous infusion. The investigators hypothesize that adductor canal block performed as intermittent boluses via a catheter will reduce morphine consumption and pain as well as enhance ambulation and muscle strength compared with continuous infusion.

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.

Postoperative Pain

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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

Intermittent bolus

ropivacaine 0.2%, 21 ml every 3 hours

Group Type EXPERIMENTAL

ropivacaine 0.2%

Intervention Type DRUG

Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM

Continuous infusion

ropivacaine 0.2%, 7ml/h

Group Type ACTIVE_COMPARATOR

ropivacaine 0.2%

Intervention Type DRUG

Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM

Interventions

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

ropivacaine 0.2%

Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Patients scheduled for total knee arthroplasty in spinal anesthesia
* Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
* American society of anesthesiologists 1-3
* Ability to perform a timed up and go test preoperatively

Exclusion Criteria

* Patients who cannot cooperate
* Patients who cannot understand or speak Danish.
* Patients with allergy to the medicines used in the study
* Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
* Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
* Rheumatoid arthritis
* BMI \> 40
* Neuromuscular pathology in the lower limbs
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

University of California, San Diego

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Smiths Medical, ASD, Inc.

INDUSTRY

Sponsor Role collaborator

Pia Jaeger

OTHER

Sponsor Role lead

Responsible Party

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

Pia Jaeger

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Gentofte Municipality, Hellerup, Denmark

Site Status

Countries

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

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Jaeger P, Baggesgaard J, Sorensen JK, Ilfeld BM, Gottschau B, Graungaard B, Dahl JB, Odgaard A, Grevstad U. Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Blinded, Controlled Clinical Trial. Anesth Analg. 2018 Jun;126(6):2069-2077. doi: 10.1213/ANE.0000000000002747.

Reference Type DERIVED
PMID: 29293181 (View on PubMed)

Other Identifiers

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

2014-005642-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SM3-PJ-14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.