Back to resultsSelective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery
Primary Purpose
Postoperative Pain, Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ropivacaine 0.5% Injectable Solution
Ropivacaine 0.2% Injectable Solution
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Patient scheduled for a total knee arthroplasty under spinal block.
- Patient with a weight above 40kg.
Exclusion Criteria:
- Patient with ASA IV status.
- Contraindication to spinal block, or peripheral nerve blocks.
- Neurological deficit of the lower limb.
- Patient with renal dysfunction.
- Patient with chronic pain, opioid consumption or alcohol consumption.
- Pregnancy.
Sites / Locations
- Eric Albrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tibial nerve block
Local infiltration analgesia
Arm Description
Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block.
Adductor canal block by the anesthetist under ultrasound guidance before spinal block. Infiltration of the knee by the surgeon with local anesthetic at the end of the surgery.
Outcomes
Primary Outcome Measures
Total morphine consumption (mg)
Secondary Outcome Measures
Total morphine consumption (mg)
Analgesic duration (minutes)
Time from the block to the first analgesic request
Pain scores (numeric rating scale, 0-10) at rest and on movement
0= no pain, 10=the worst pain imaginable
Rate of postoperative nausea and vomiting
Yes/No
Rate of prurit
Yes/No
Active flexion
Flexion of the knee by the patient measured in degrees
Passive flexion
Flexion of the knee by physiotherapist measured in degrees
Quadriceps muscle strength (numeric scale, 1-5)
1=no contraction, 5=normal strength
Distance walked (meters)
Complication of tibial nerve block
Intravascular injection/hematoma/infection/Common peroneal nerve block
Length of stay in hospital
Days
Full Information
NCT ID
NCT03698006
First Posted
October 2, 2018
Last Updated
October 7, 2022
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT03698006
Brief Title
Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery
Official Title
Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tibial nerve block
Arm Type
Experimental
Arm Description
Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block.
Arm Title
Local infiltration analgesia
Arm Type
Active Comparator
Arm Description
Adductor canal block by the anesthetist under ultrasound guidance before spinal block. Infiltration of the knee by the surgeon with local anesthetic at the end of the surgery.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Intervention Description
Tibial nerve block with 10ml of Ropivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2% Injectable Solution
Intervention Description
Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule
Primary Outcome Measure Information:
Title
Total morphine consumption (mg)
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Total morphine consumption (mg)
Time Frame
2 hours, 48 hours and 72 hours postoperatively
Title
Analgesic duration (minutes)
Description
Time from the block to the first analgesic request
Time Frame
Postoperative day 0
Title
Pain scores (numeric rating scale, 0-10) at rest and on movement
Description
0= no pain, 10=the worst pain imaginable
Time Frame
2 hours, 24 hours, 48 hours and 72 hours postoperatively
Title
Rate of postoperative nausea and vomiting
Description
Yes/No
Time Frame
2 hours, 24 hours, 48 hours and 72 hours postoperatively
Title
Rate of prurit
Description
Yes/No
Time Frame
2 hours, 24 hours, 48 hours and 72 hours postoperatively
Title
Active flexion
Description
Flexion of the knee by the patient measured in degrees
Time Frame
24hours, 48hours and 72hours postoperatively
Title
Passive flexion
Description
Flexion of the knee by physiotherapist measured in degrees
Time Frame
24hours, 48hours and 72hours postoperatively
Title
Quadriceps muscle strength (numeric scale, 1-5)
Description
1=no contraction, 5=normal strength
Time Frame
24hours, 48hours and 72hours postoperatively
Title
Distance walked (meters)
Time Frame
24hours, 48hours and 72hours postoperatively
Title
Complication of tibial nerve block
Description
Intravascular injection/hematoma/infection/Common peroneal nerve block
Time Frame
up to 1 week
Title
Length of stay in hospital
Description
Days
Time Frame
up to 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient scheduled for a total knee arthroplasty under spinal block.
Patient with a weight above 40kg.
Exclusion Criteria:
Patient with ASA IV status.
Contraindication to spinal block, or peripheral nerve blocks.
Neurological deficit of the lower limb.
Patient with renal dysfunction.
Patient with chronic pain, opioid consumption or alcohol consumption.
Pregnancy.
Facility Information:
Facility Name
Eric Albrecht
City
Lausanne
State/Province
English
ZIP/Postal Code
1004
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22543069
Citation
Sinha SK, Abrams JH, Arumugam S, D'Alessio J, Freitas DG, Barnett JT, Weller RS. Femoral nerve block with selective tibial nerve block provides effective analgesia without foot drop after total knee arthroplasty: a prospective, randomized, observer-blinded study. Anesth Analg. 2012 Jul;115(1):202-6. doi: 10.1213/ANE.0b013e3182536193. Epub 2012 Apr 27.
Results Reference
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Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery
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