- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04814303
Impact of Adductor Canal Block on Functional Recovery
March 22, 2021 updated by: Shimaa Abbas Hassan, Assiut University
Adductor Canal Block Versus Periarticular Infiltration Effect on Functional Outcome In Patients Undergoing Total Knee Replacement
TKA involves extensive bone resection as well as soft tissue excision and therefore is associated with profound postoperative pain.
Adequate analgesia after TKA is therefore considered paramount to facilitate early hospital discharge and effective functional recovery.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis (OA) of the knee has become a major public health issue and imposes a significant healthcare burden and accounts for high annual hospitalizations.
Chronic OA of the knee may lead to reduced physical fitness, mobility disability with a resultant increased risk of cardio-metabolic comorbidity and early mortality.
Total knee arthroplasty (TKA) is indicated in severe cases to improve long-term pain and function.
(1) TKA involves extensive bone resection as well as soft tissue excision and therefore is associated with profound postoperative pain.
(2) Inadequate perioperative pain control may prolong hospitalization, hinder early rehabilitation, and is also a strong predictor of persistent pain beyond 3 months.
(3) Adequate analgesia after TKA is therefore considered paramount to facilitate early hospital discharge and effective functional recovery.
(4) The recently introduced adductor canal block (ACB) typically covers the anterio-medial aspect of the knee and preserves quadriceps function, which presumably enhances postoperative rehabilitation by allowing patients to actively participate in knee movement.
The relative effectiveness of this ACB technique added to intrathecal morphine is limited to a single study (1) in which assessment of short-term functional recovery was done and dexamethasone was neither included in the LIA solution nor perineurally in the ACB.
Thus, we hypothesize that adductor canal block as an adjunct to intrathecal morphine will have a better impact on functional recovery than peri-articular infiltration.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shimaa A hassan, M.D.
- Phone Number: 01002953253
- Email: shimaa.abbas@med.aun.edu.eg
Study Contact Backup
- Name: Amira M Gad, M.B.B.CH
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American Society of Anesthesiologist class ( ASA) I - III
- BMI 18-35 kg/m2
- Scheduled for primary unilateral TKR
Exclusion Criteria:
- Known allergy to local anesthetics
- Contraindication to adductor canal block e.g. infection at the site of injection
- Contraindication to spinal anesthesia e.g. coagulopathy.
- Patients with pre-existing motor or sensory deficits in lower extremities.
- Patients who are morbidly obese (BMI≥35) because ultrasound-guided regional anesthesia could be technically difficult.
- Bilateral or revision total knee replacement
- Insulin or noninsulin-dependent diabetes mellitus.
- systemic corticosteroid use within 30-days of surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ITM
spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral and Intrathecal morphine 150 μg will be added.
|
After applying standard monitoring of pulse oximetry, ECG, NIBP; while the patient in the sitting position following complete sterile aseptic condition after sterilization bovine bethidine spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral levels using a 25- gauge Whitacre needle.
Intrathecal morphine 150 μg will be added to patients of both groups.
Supplemental oxygen will be administered via a simple face mask.
|
Active Comparator: ACB
spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral and Intrathecal morphine 150 μg will be added.
The block will be performed in the mid adductor canal to block both the saphenous and the nerve to vastus medialis.
After skin infiltration with 1 to 2 mL of 2% lidocaine, an 80-mm, 22-gauge, the short-bevel echogenic needle is advanced in-plane with the ultrasound beam in an anterior-to-posterior direction until the tip is located within the adductor canal deep to the vastoadductor membrane.
After negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection plane.
The study solution will be injected within the canal adjacent to the femoral artery.
Patients in this group received 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine and 4 mg dexamethasone.
|
After applying standard monitoring of pulse oximetry, ECG, NIBP; while the patient in the sitting position following complete sterile aseptic condition after sterilization bovine bethidine spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral levels using a 25- gauge Whitacre needle.
Intrathecal morphine 150 μg will be added to patients of both groups.
Supplemental oxygen will be administered via a simple face mask.
The block will be performed in the mid adductor canal to block both the saphenous and the nerve to vastus medialis.
After skin infiltration with 1 to 2 mL of 2% lidocaine, an 80-mm, 22-gauge, short-bevel echogenic needle is advanced in plane with the ultrasound beam in an anterior-to-posterior direction until the tip is located within the adductor canal deep to the vastoadductor membrane.
After negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection plane.
The study solution will be injected within the canal adjacent to the femoral artery.
Patients in group 1 received 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine and 4 mg dexamethasone.
|
Active Comparator: PAI
spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral and Intrathecal morphine 150 μg will be added.
PAI intra-operatively will be performed with 150 mL of 0.25% bupivacaine with 1:400,000 epinephrine, 30 mg of ketorolac, and 8 mg dexamethasone.
|
After applying standard monitoring of pulse oximetry, ECG, NIBP; while the patient in the sitting position following complete sterile aseptic condition after sterilization bovine bethidine spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral levels using a 25- gauge Whitacre needle.
Intrathecal morphine 150 μg will be added to patients of both groups.
Supplemental oxygen will be administered via a simple face mask.
the surgeon will perform the PAI intra-operatively; 150 mL of 0.25% bupivacaine with 1:400,000 epinephrine, 30 mg of ketorolac, and 8 mg dexamethasone.
Half of the solution will be administered into the posterior capsule and posterior soft tissues of the knee under direct vision after osteotomy but before insertion of the implants.
The remaining half of the solution will be administered into the anterior soft tissues after placement of the implants and before skin closure.
All local infiltration will be carried out while a thigh tourniquet (used to limit surgical bleeding) was inflated at a pressure of 300 to 350 mm Hg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Timed Up and Go" test (TUG)
Time Frame: 48 hours
|
reflects the time it takes a subject to stand up from a standard-height armchair, walk 3 m, walk back to the chair, and sit down.
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale (VAS) at rest
Time Frame: 72 hours
|
will be used to assess knee pain intensity
|
72 hours
|
Visual analogue scale (VAS) at movement
Time Frame: 72 hours
|
will be used to assess knee pain intensity
|
72 hours
|
Time to first analgesic request
Time Frame: 72 hours
|
the first time the patient ask for analgesia
|
72 hours
|
Total analgesic consumption
Time Frame: 72 hours
|
Total consumption of postoperative rescue analgesics (total of paracetamol doses) will be recorded
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2021
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
March 22, 2021
First Submitted That Met QC Criteria
March 22, 2021
First Posted (Actual)
March 24, 2021
Study Record Updates
Last Update Posted (Actual)
March 24, 2021
Last Update Submitted That Met QC Criteria
March 22, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adductor canal block in TKR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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