Total Knee ReplacementNCT04814303
Impact of Adductor Canal Block on Functional Recovery
A study testing Intrathecal morphine, Adductor Canal block and Peri-articular Infilteration in people with Total Knee Replacement, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Intrathecal morphine, Adductor Canal block and Peri-articular Infilteration
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist class ( ASA) I - III
- BMI 18-35 kg/m2
- Scheduled for primary unilateral TKR
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Amira M Gad, M.B.B.CH contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Total Knee Replacement
- Being tested
- Intrathecal morphine, Adductor Canal block, Peri-articular Infilteration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphineProcedure or surgery
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.
Adductor Canal blockProcedure or surgery
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.
Peri-articular InfilterationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ITM | Active comparator | 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. Receives: Procedure: Intrathecal morphine |
| ACB | Active comparator | 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. Receives: Procedure: Intrathecal morphine; Procedure: Adductor Canal block |
| PAI | Active comparator | 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. Receives: Procedure: Intrathecal morphine; Procedure: Peri-articular Infilteration |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Timed Up and Go" test (TUG)
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.
Measured: 48 hours
Secondary outcomes (4)
Visual analogue scale (VAS) at rest
will be used to assess knee pain intensity
Measured: 72 hours
Visual analogue scale (VAS) at movement
will be used to assess knee pain intensity
Measured: 72 hours
Time to first analgesic request
the first time the patient ask for analgesia
Measured: 72 hours
Total analgesic consumption
Total consumption of postoperative rescue analgesics (total of paracetamol doses) will be recorded
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Abbas Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814303
- Sponsor's protocol ID
- Adductor canal block in TKR
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block Versus Periarticular Infiltration Effect on Functional Outcome In Patients Undergoing Total Knee Replacement
- ClinicalTrials.gov ID
- NCT04814303
- Acronym / sponsor ID
- Adductor canal block in TKR
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ITM | Active comparator | Procedure: Intrathecal morphinespinal 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. |
| ACB | Active comparator | Procedure: Intrathecal morphine, Procedure: Adductor Canal blockspinal 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. |
| PAI | Active comparator | Procedure: Intrathecal morphine, Procedure: Peri-articular Infilterationspinal 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist class ( ASA) I - III
- BMI 18-35 kg/m2
- Scheduled for primary unilateral TKR
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal morphineAfter 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. | Procedure or surgery | ACB, ITM, PAI |
| Adductor Canal blockThe 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. | Procedure or surgery | ACB |
| Peri-articular Infilterationthe 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. | Procedure or surgery | PAI |
Primary outcome
"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.
4 secondary outcomes
Visual analogue scale (VAS) at rest
Time frame: 72 hours
Visual analogue scale (VAS) at movement
Time frame: 72 hours
Time to first analgesic request
Time frame: 72 hours
Total analgesic consumption
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira M Gad, M.B.B.CH contact
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal morphine, Adductor Canal block and Peri-articular Infilteration in people with Total Knee Replacement, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa A Hassan, M.D. (01002953253, shimaa.abbas@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Timed Up and Go" test (TUG) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.