The effect of Adductor-Channel Blockade with high pain responders after reconstruction of the anterior cruciate ligament
- Conditions
- Patients who will undergo reconstruktion of ligament cruciate ligament.MedDRA version: 14.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-000663-83-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Age> 18 years and <80 years
• Patients in the recovery ward (before discharge to home) indicates a postoperative VAS score = 40 at 45 degrees inward inflexion of the knee after reconstruction of the anterior cruciate ligament (ACL) with a hamstring graft with general anesthesia and without administration of opioid in the last 30 minutes before inclusion.
• Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations in full.
• ASA I-III.
• BMI> 18 and <40
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Patients who are operating in blood emptiness (used a cuff)
• Patients who can not cooperate with the investigation.
• Patients who do not understand or speak Danish.
• Allergy to those used in the study drugs.
• Pregnancy, studied with HCG urinstiks on the day of surgery when possible pregnancy.
• Alcohol and / or drug abuse - the investigator's opinion.
• Daily consumption of opioid
• Infection at the injection area
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable;Primary end point(s): •Forskel i smertescore ved 45 graders aktiv flektion af knæled 45 minutter (t45) efter anlæggelse af AKB med 30 mL ropivacain 7.5 mg/mL versus placebo;Timepoint(s) of evaluation of this end point: painscore at the time 45 and 90 minutes after studydrug has been given<br>;Main Objective: The purpose of this study is to investigate the analgesic effect of BAC in patients with moderate to severe pain (VAS = 40 mm) after reconstruction of the anterior cruciate ligament (hamstring graft). The hypothesis is that the BAC will reduce post-operative pain, maintain muscle strength, and to reduce the post-operative use of opioid compared to placebo.<br>The purpose of the study is therefore to clarify whether BAC can and should be used in the subgroup of patients who have moderate to severe pain after cruciate ligament
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The difference in pain scores at rest 45 minutes (t45) after the construction of BAC with 30 mL of ropivacaine 7.5 mg / mL versus placebo.<br>• The difference in pain scores at 45 degrees inward inflexion of knee 90 minutes (t90) after the construction of BAC between the two treatment groups<br>• The difference in pain scores at rest 90 minutes (t90) after the construction of BAC between the two treatment groups<br>• Maximum pain (VAS) for 5 meter walk and with full load on the operated leg at times t45 and t90<br>• Patient assessment of change in muscle strength after BAC assessed within the 5 meter walk to the times t45 and t90;Timepoint(s) of evaluation of this end point: painscore at the time 45 and 90 minutes after studydrug has been given