Study Results
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.
COMPLETED
NA
81 participants
INTERVENTIONAL
2013-03-31
2014-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment
NCT01307202
Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study
NCT00889148
Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy
NCT06112223
Postoperative Analgesia After Total Knee Arthroplasty
NCT00421967
Implementation of a Pain Management Protocol for Total Knee Arthroplasty
NCT02474654
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Prospective randomised study
Study population:
Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study.
Intervention:
The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. The second group will receive local infiltration with ropivacaine of the knee during surgery. Half of these patients will additionally be treated with gabapentin.
Primary study parameters/outcome of the study:
NRS-score (11-scale Numeric Rating Scale in which 0 means no pain, and 10 means most pain imaginable) in rest.
Secondary study parameters/outcome of the study:
Speed of mobilisation, postoperative opiate consumption. NRS scores during flexion exercise of the knee and during walking exercise.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
epidural analgesia
The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced.
marcaine
bupivacaine 0,125%
sufentanil
sufentanil 1mcg/ml
local infiltration
The second group will receive local infiltration with ropivacaine of the knee during surgery.
naropin
ropivacaine 0,2%, 3x 50 ml during surgery
local infiltration and gabapentin
The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin.
naropin
ropivacaine 0,2%, 3x 50 ml during surgery
neurontin
gabapentin 600 mg pre-operative 3 dd 300 mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
naropin
ropivacaine 0,2%, 3x 50 ml during surgery
marcaine
bupivacaine 0,125%
sufentanil
sufentanil 1mcg/ml
neurontin
gabapentin 600 mg pre-operative 3 dd 300 mg
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Waiting for total knee replacement surgery
* Informed consent
Exclusion Criteria
* Aortic Valve stenosis
* Severely compromised cardiac function
* infection near epidural punction site
* Redo knee surgery
* Previous arthrotomies
* Allergy/Hypersensitivity for study mediation or all other used medication
* Participation in other studies
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. Antonius Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Leon Timmerman
anesthesiologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Leon Timmerman, MD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiologist
Louis N Marting, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopedic surgeon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Antonius Hospital
Nieuwegein, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TKP-37796
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.