The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty
This study has been completed.
Sponsor:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01261897
First received: December 16, 2010
Last updated: October 3, 2011
Last verified: October 2011
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Purpose
The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain Knee Arthroplasty |
Procedure: Adductor-Canal-Blockade with Ropivacaine Procedure: Adductor-Canal-blockade with saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty |
Resource links provided by NLM:
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- Pain during 45 degrees active flexion of the knee [ Time Frame: 1 hour postoperative ] [ Designated as safety issue: No ]0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative
Secondary Outcome Measures:
- Pain during 45 degrees active flexion of the knee [ Time Frame: 0-6 hours postoperative ] [ Designated as safety issue: No ]0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
- Pain during rest [ Time Frame: 1-6 hours postoperative ] [ Designated as safety issue: No ]0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
- A change in pain score in the ropivacaine group, after activating the block [ Time Frame: 30-60 minutes postoperative ] [ Designated as safety issue: No ]0-100 mm at a visual analogue scale (VAS), at 30 and 60 minutes postoperative. A change in pain score in the ropivacaine group compared to the placebo group, after activating the block.
- Total morphine consumption [ Time Frame: 30 minutes - 6 hours postoperative ] [ Designated as safety issue: No ]Total morphine consumption at the interval 30 minutes - 6 hours postoperative.
- Postoperative nausea [ Time Frame: 1-6 hours postoperative ] [ Designated as safety issue: No ]Nausea scores(0-3)registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as mean value for the interval 1-6 hours postoperative.
- Postoperative vomiting [ Time Frame: 1-6 hours postoperative ] [ Designated as safety issue: No ]Number of vomiting episodes at the interval 1-6 hours postoperative.
- Zofran consumption [ Time Frame: 1-6 hours postoperative ] [ Designated as safety issue: No ]Total zofran consumption at the intervals 1-6 hours postoperative.
- Sedation [ Time Frame: 1-6 hours postoperative ] [ Designated as safety issue: No ]Sedation score (0-3) registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the mean value for the interval 1-6 hours postoperative.
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Adductor-Canal-Blockade with Ropivacaine |
Procedure: Adductor-Canal-Blockade with Ropivacaine
US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
Other Names:
|
| Placebo Comparator: Adductor-Canal-blockade with saline |
Procedure: Adductor-Canal-blockade with saline
US-guided Adductor-Canal-blockade with saline
Other Name: Sham block
|
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Total Knee Arthroplasty in general anaesthesia
- ASA 1-3
- BMI 18-40
- Written informed consent
Exclusion Criteria:
- Can not cooperate to the exam
- Do not speak or understand Danish
- Drug allergy
- Alcohol or drug abuse
- Daily consumption of strong opioids
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261897
Locations
| Denmark | |
| Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital | |
| Gentofte, Hellerup, Denmark, 2900 | |
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
| Principal Investigator: | Pia Jæger, MD | Rigshospitalet, Denmark |
More Information
No publications provided by Rigshospitalet, Denmark
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pia Jaeger, MD, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01261897 History of Changes |
| Other Study ID Numbers: | SM2-PJ-10, 2010-021918-30 |
| Study First Received: | December 16, 2010 |
| Last Updated: | October 3, 2011 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency |
Keywords provided by Rigshospitalet, Denmark:
|
Adductor-Canal-Blockade postoperative pain US-guided nerve block total knee arthroplasty |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Morphine Ropivacaine Analgesics, Opioid Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics Anesthetics, Local Anesthetics |
ClinicalTrials.gov processed this record on June 18, 2013