Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy
NCT ID: NCT01837394
Last Updated: 2013-11-06
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
PHASE4
60 participants
INTERVENTIONAL
2012-08-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
We wish to investigate the analgesic effect of these two blocks compared to placebo (injection of local anesthetic with known pain blocking properties compared with injection of a saline solution), when used as a supplement to conventional oral analgesics.
We hypothesize that patients receiving the active treatment may experience less pain during the first 24 hours after their operation than patients receiving the placebo treatment, and possibly require less opioid analgesics, experience less opioid related side effects and have a higher function level in this period than patients receiving the placebo treatment.
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.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Block arm
Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
Block of the SN and ONP
7.5 ml of Ropivacaine 7.5 mg/ml injected at each site
Paracetamol
Morphine
5 mg as needed
Ondansetron
4 mg i.v. as needed in the PACU
Metoclopramide
10 mg tablet as needed in the postoperative period after discharge from the PACU
Placebo arm
Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
Placebo block
7.5 ml of isotonic saline solution 154 mmol/l injected at each site
Paracetamol
Morphine
5 mg as needed
Ondansetron
4 mg i.v. as needed in the PACU
Metoclopramide
10 mg tablet as needed in the postoperative period after discharge from the PACU
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Block of the SN and ONP
7.5 ml of Ropivacaine 7.5 mg/ml injected at each site
Placebo block
7.5 ml of isotonic saline solution 154 mmol/l injected at each site
Paracetamol
Morphine
5 mg as needed
Ondansetron
4 mg i.v. as needed in the PACU
Metoclopramide
10 mg tablet as needed in the postoperative period after discharge from the PACU
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
* American Society of Anesthesiologists (ASA) class 1-3
Exclusion Criteria
* Do not speak or understand Danish
* Daily use of opioid analgesics
* Allergy towards any of the drugs used in the investigation
* Medicine abuse (at the investigators discretion)
* Alcohol abuse, as defined by the National Board of Health
* General anesthesia contraindicated, or the patient wants spinal anesthesia
* Visualization of necessary structures by ultrasound not possible, or block not possible for other technical reasons
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jens Borglum Neimann
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jens Borglum Neimann
MD, PhD, MBA
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bo Westergaard, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Bispebjerg Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Anesthesiology, Bispebjerg Hospital
Copenhagen, , Denmark
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.
H-2-2011-029
Identifier Type: -
Identifier Source: org_study_id