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Combined Saphenous Nerve and IPACK Blocks Versus Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT03680716
Recruitment Status : Completed
First Posted : September 21, 2018
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Study Description
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Brief Summary:
A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). The objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with IPACK block is more effective for the postoperative pain than a local infiltration analgesia.

Condition or disease Intervention/treatment Phase
Postoperative Pain Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture Drug: Ropivacaine injection Not Applicable

Detailed Description:

The saphenous nerve and the iPACK will be performed after general anaesthesia induction and before the surgery under ultrasound-guidance.

The local infiltration analgesia will be performed by the surgeon during the surgery.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of a Combined Saphenous Nerve Block and IPACK Block Versus Local Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Double-blinded Trial.
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IPACK block
Saphenous nerve block and IPACK block by anesthetist under ultrasound guidance.
 Drug: Ropivacaine injection
Saphenous nerve block with 20ml of ropivacaine 0.5% and IPACK block with 30ml of ropivacaine 0.2% (total dose of 160 mg).
Active Comparator: Local infiltration analgesia
Periarticular infiltration by surgeon
 Drug: Ropivacaine injection
Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).


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

Secondary Outcome Measures :
  1. Total morphine consumption (mg) [ Time Frame: 2 hours, 48 hours and 72 hours postoperatively ]
  2. Pain scores (numeric rating scale, 0-10) at rest and on movement [ Time Frame: 2hours, 24hours, 48hours and 72hours postoperatively ]
    0= no pain, 10=the worst pain imaginable

  3. Rate of postoperative nausea and vomiting [ Time Frame: 2hours, 24hours, 48hours and 72hours postoperatively ]
    Yes/No

  4. Rate of antiemetic consumption [ Time Frame: 2hours, 24hours, 48hours and 72hours postoperatively ]
    Yes/No

  5. Rate of pruritus [ Time Frame: 2hours, 24hours, 48hours and 72hours postoperatively ]
    Yes/No

  6. Active flexion [ Time Frame: 24hours, 48hours and 72hours postoperatively ]
    Flexion of the knee by the patient measured in degrees

  7. Quadriceps muscle strength (numeric scale, 1-5) [ Time Frame: 24hours, 48hours and 72hours postoperatively ]
    1=no contraction, 5=normal strength

  8. Distance walked (meters) [ Time Frame: 24 hours, 48hours and 72hours postoperatively ]
  9. Anterior Cruciate Ligament - Return to Sport after Injury survey [ Time Frame: 4 and 8 postoperative months ]
  10. International Knee Documentation Committee score [ Time Frame: 4 and 8 postoperative months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Statut ASA I-III.
  • Patient scheduled for anterior crutiate ligament reconstruction under general anesthesia.

Exclusion Criteria:

  • Pregnancy.
  • Contraindication to local anesthesia.
  • Patient with chronic pain, opioid consumption or alcohol consumption.
  • Patient with coagulation trouble, hepatic dysfunction or renal dysfunction.
  • Patient with diabetic or femoral neuropathy.
Contacts and Locations
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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): NCT03680716


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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eric Albrecht, Program director of regional anaesthesia, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03680716    
Other Study ID Numbers: CER 2018-01163
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries
Ropivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents