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Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT02524652
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Brief Summary:
Early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. Regarding this latter, different options have emerged recently such as the adductor canal block, performed before the surgery by the anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of the intervention. No trial has compared these two approaches. As practice of medicine should be based on evidence, we decided to undertake this randomised controlled trial where we compared the adductor canal block with the local infiltration analgesia technique in terms of pain and functional outcomes

Condition or disease Intervention/treatment Phase
Rupture of Anterior Cruciate Ligament Infiltration Regional Anesthesia Morbidity Drug: Ropivacaine 0.5% 20 mLs Phase 4

Detailed Description:

Patients scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be randomly allocated to two groups: local infiltration analgesia or adductor canal block.

The local infiltration analgesia will be performed by the surgeon at the end of surgery with 20 mLs of ropivacaine 0.5%. The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient, using the same solution (20 mLs ropivacaine 0.5%)

Postoperative analgesia will include intravenous patient-controlled analgesia of morphine (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3x400 mg) and acetaminophen (4x1000 mg).

A research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial
Study Start Date : September 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018


Arm Intervention/treatment
Experimental: Local infiltration analgesia
Infiltration of the knee by the surgeon with local anaesthetics under general anaesthesia.
Drug: Ropivacaine 0.5% 20 mLs
Injection of the local anesthetic at the end of surgery, either in the surgical sites by the surgeon, or in the adductor canal block by the anesthesiologist under ultrasound guidance.
Other Name: Naropine, Naropin

Active Comparator: Adductor canal block
Injection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist after the surgery, before awaking the patient.
Drug: Ropivacaine 0.5% 20 mLs
Injection of the local anesthetic at the end of surgery, either in the surgical sites by the surgeon, or in the adductor canal block by the anesthesiologist under ultrasound guidance.
Other Name: Naropine, Naropin




Primary Outcome Measures :
  1. Total morphine consumption (mg) [ Time Frame: 24 h postoperatively ]

Secondary Outcome Measures :
  1. Total morphine consumption (mg) [ Time Frame: 2 h postoperatively ]
  2. Total morphine consumption (mg) [ Time Frame: 48 h postoperatively ]
  3. Total morphine consumption (mg) [ Time Frame: 72 h postoperatively ]
  4. Pain scores (numeric rating scale, 0-10) at rest and on movement [ Time Frame: 2 h postoperatively ]
  5. Pain scores (numeric rating scale, 0-10) at rest and on movement [ Time Frame: 12 h postoperatively ]
  6. Pain scores (numeric rating scale, 0-10) at rest and on movement [ Time Frame: 24 h postoperatively ]
  7. Pain scores (numeric rating scale, 0-10) at rest and on movement [ Time Frame: 36 h postoperatively ]
  8. Pain scores (numeric rating scale, 0-10) at rest and on movement [ Time Frame: 48 h postoperatively ]
  9. Pain scores (numeric rating scale, 0-10) at rest and on movement [ Time Frame: 60 h postoperatively ]
  10. Pain scores (numeric rating scale, 0-10) at rest and on movement [ Time Frame: 72 h postoperatively ]
  11. Postoperative nausea and vomiting (yes/no) [ Time Frame: 24 h postoperatively ]
  12. Postoperative nausea and vomiting (yes/no) [ Time Frame: 48 h postoperatively ]
  13. Postoperative nausea and vomiting (yes/no) [ Time Frame: 72 h postoperatively ]
  14. Pruritus (yes/no) [ Time Frame: 24 h postoperatively ]
  15. Pruritus (yes/no) [ Time Frame: 48 h postoperatively ]
  16. Pruritus (yes/no) [ Time Frame: 72 h postoperatively ]
  17. Active flexion [ Time Frame: 24 h postoperatively ]
    Flexion of the knee by the patient measured in degrees

  18. Active flexion [ Time Frame: 48 h postoperatively ]
    Flexion of the knee by the patient measured in degrees

  19. Active flexion [ Time Frame: 72 h postoperatively ]
    Flexion of the knee by the patient measured in degrees

  20. Quadriceps muscle strength (numeric scale, 1-5) [ Time Frame: 24 h postoperatively ]
  21. Quadriceps muscle strength (numeric scale, 1-5) [ Time Frame: 48 h postoperatively ]
  22. Quadriceps muscle strength (numeric scale, 1-5) [ Time Frame: 72 h postoperatively ]
  23. Distance walked (meters) [ Time Frame: 24 h postoperatively ]
  24. Distance walked (meters) [ Time Frame: 48 h postoperatively ]
  25. Distance walked (meters) [ Time Frame: 72 h postoperatively ]
  26. Anterior Cruciate Ligament - Return to Sport after Injury scale [ Time Frame: 4 months postoperatively ]
  27. Anterior cruciate ligament -Return to Sport after Injury scale [ Time Frame: 8 months postoperatively ]
  28. International Knee Documentation Committee score [ Time Frame: 4 months postoperatively ]
  29. International Knee Documentation Committee score [ Time Frame: 8 months postoperatively ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction

Exclusion Criteria:

  • peripheral neuropathy
  • pre-existing femoral neuropathy
  • diabetes mellitus
  • alcoholism
  • drug addiction
  • cancer with chemotherapy
  • chronic pain state

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524652


Locations
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Switzerland
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Eric Albrecht, PD Dr CHUV
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Albrecht, Program Director, Regional Anaesthesia, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02524652    
Other Study ID Numbers: CER 193-15
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents