Postoperative PainNCT04396652
Peri-articular Injection and (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.
A study testing Adductor canal block (ACB) group, Peri-articular injection group and Adductor canal block and IPACK block group in people with Postoperative Pain and Regional Anesthesia, run by Tanta University at 1 site in Egypt.
Trial summary
This is a prospective randomized double blind controlled study to evaluate the post-operative analgesic effect of adductor canal block (ACB) or peri-articular injection (PAIs) compared to combined adductor canal block and infiltration of the interspace between popliteal artery and the capsule of posterior knee block … Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Postoperative Pain, Regional Anesthesia
- What is being tested?
- Adductor canal block (ACB) group, Peri-articular injection group and Adductor canal block and IPACK block group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 15 Sep 2021
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty
Who cannot join
- Patient who refuse the regional anesthesia technique.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
- Patient with Advanced renal, hepatic and cardiac diseases.
- Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in comprehending (NRS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Adductor Canal Block, Peri-articular Injection or Infiltration Between Popliteal Artery and Posterior Knee Capsule (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.
This is a prospective randomized double blind controlled study to evaluate the post-operative analgesic effect of adductor canal block (ACB) or peri-articular injection (PAIs) compared to combined adductor canal block and infiltration of the interspace between popliteal artery and the capsule of posterior knee block ( IPACK) in patient undergoing total knee arthroplasty
Read the detailed description
This prospective randomized study will be carried out in Tanta University Hospitals in Anesthesia Department for one year after approval from ethical committee of faculty of medicine of Tanta university. After approval from institutional ethics committee, an informed consent will be taken from each patient. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only. Any unexpected risks encountered during the course of the research will be cleared to the participants as well as to the Ethical Committee on time. Every patient will receive an explanation to the purpose of the study and every patient will have a secret code number to ensure privacy to participants and confidentiality of data.
Inclusion criteria:
Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty will be enrolled in the study.
Exclusion criteria:
- Patient who refuse the regional anesthesia technique.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
- Patient with Advanced renal, hepatic and cardiac diseases.
- Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in comprehending (NRS).
Grouping and Allocation:
60 patients will be enrolled in this study in each group, Patients will be randomly classified into three equal groups (20 patients each).
Randomization will be done by computer generated numbers into:
Group (I): 20 patients will receive adductor canal block alone. Group (II): 20 Patients will receive peri-articular injection alone. Group (III): 20 patients will receive adductor canal block (ACB) and infiltration of the interspace between popliteal artery and the capsule of posterior knee block (IPACK).
Anesthetic technique:
Preoperative assessment will be done by:
History talking, clinical examination, routine laboratory investigations including CBC, coagulation profile, random blood sugar, liver and renal function tests. During the pre-anesthetic assessment, all patients will be familiarized with Numeric Rating Scale (NRS) score. On entering the operating room, intravenous line (IV) will be inserted, routine monitoring of heart rate by ECG, noninvasive blood pressure (NIBP), pulse oximetry will be done. All patients will receive spinal anesthesia with 3 ml 0.5% (15 mg) hyperbaric bupivacaine plus 25 μgm fentanyl at the L3/4 interspaces and the study of regional anesthetic technique will be performed postoperatively according to each group. All patients will receive postoperative analgesic regimen which is paracetamol 1gm intravenously every 8 hours and ketorolac 30mg every12 hours. Rescue analgesia in the form of 0.05 mg/kg of morphine IV will be administrated when the Numeric Rating Score (NRS) exceeding 3. The morphine dose will be repeated whenever indicated considering the total dose in the first 24 hours never exceeding 20 mg.
Measurements:
- Demographic data (age, gender, weight, ASA classification).
- Post-operative pain will be assessed by Numeric Rating Scale (NRS) from 0 to 10 at 0,2,4,6 then every 6h for 24 hours and in the second and third postoperative days at rest and during Physiotherapy.
- Postoperative analgesia, which will be assessed by total analgesic consumption, and time till administration of first rescue analgesia will be recorded.
- Effect on Motor function: by recording the mean time taken to achieve 90o active knee flexion each day till the third postoperative day.
- Adverse effects: hypotension, Bradycardia, infection, hematoma and local anesthetic toxicity will be observed and treated accordingly.
- Conditions
- Postoperative Pain, Regional Anesthesia
- Being tested
- Adductor canal block (ACB) group, Peri-articular injection group, Adductor canal block and IPACK block group
- Keywords
- peri-articular injection, adductor canal block, IPACK, Total knee arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal block (ACB) groupProcedure or surgery
Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal
Peri-articular injection groupProcedure or surgery
Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon.
A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL
Adductor canal block and IPACK block groupProcedure or surgery
Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block (ACB) group | Experimental | Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal Receives: Procedure: Adductor canal block (ACB) group |
| Peri-articular injection group | Experimental | Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon.
A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL Receives: Procedure: Peri-articular injection group |
| Adductor canal block and IPACK block group | Experimental | Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected Receives: Procedure: Adductor canal block and IPACK block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post-operative pain will be assessed at rest and during physiotherapy by Numeric Rating Scale from (0-10) '0' representing "no pain" to '10' representing "worst pain imaginable"
Measured: After the resolution of the effect of spinal anesthesia for 72 hours postoperative
Secondary outcomes (3)
Postoperative analgesia
Total analgesic consumption will be recorded
Measured: First 24 hours postoperatively
Duration of the block
Time till administration of first rescue analgesia will be recorded
Measured: First 24 hours postoperatively
Effect on Motor function
By recording the mean time taken to achieve 90o active knee flexion
Measured: Each day till the third postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Jul 2020
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shebl Abdelghany, Tanta University
- Investigators
- Mohammed S Abdelghany, Lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396652
- Sponsor's protocol ID
- 33748/3/20
- Other IDs
- Tanta University
- Status last verified
- Oct 2021
- First submitted
- 5 May 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the study had been successfully completed, the data will be shared for other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adductor Canal Block, Peri-articular Injection or Infiltration Between Popliteal Artery and Posterior Knee Capsule (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT04396652
- Acronym / sponsor ID
- 33748/3/20
- Conditions
- Postoperative Pain, Regional Anesthesia
- Keywords
- peri-articular injection, adductor canal block, IPACK, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 20 May 2020 (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.
This is a prospective randomized double blind controlled study to evaluate the post-operative analgesic effect of adductor canal block (ACB) or peri-articular injection (PAIs) compared to combined adductor canal block and infiltration of the interspace between popliteal artery and the capsule of posterior knee block ( IPACK) in patient undergoing total knee arthroplasty
Detailed description
This prospective randomized study will be carried out in Tanta University Hospitals in Anesthesia Department for one year after approval from ethical committee of faculty of medicine of Tanta university. After approval from institutional ethics committee, an informed consent will be taken from each patient. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only. Any unexpected risks encountered during the course of the research will be cleared to the participants as well as to the Ethical Committee on time. Every patient will receive an explanation to the purpose of the study and every patient will have a secret code number to ensure privacy to participants and confidentiality of data.
Inclusion criteria:
Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty will be enrolled in the study.
Exclusion criteria:
- Patient who refuse the regional anesthesia technique.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
- Patient with Advanced renal, hepatic and cardiac diseases.
- Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in comprehending (NRS).
Grouping and Allocation:
60 patients will be enrolled in this study in each group, Patients will be randomly classified into three equal groups (20 patients each).
Randomization will be done by computer generated numbers into:
Group (I): 20 patients will receive adductor canal block alone. Group (II): 20 Patients will receive peri-articular injection alone. Group (III): 20 patients will receive adductor canal block (ACB) and infiltration of the interspace between popliteal artery and the capsule of posterior knee block (IPACK).
Anesthetic technique:
Preoperative assessment will be done by:
History talking, clinical examination, routine laboratory investigations including CBC, coagulation profile, random blood sugar, liver and renal function tests. During the pre-anesthetic assessment, all patients will be familiarized with Numeric Rating Scale (NRS) score. On entering the operating room, intravenous line (IV) will be inserted, routine monitoring of heart rate by ECG, noninvasive blood pressure (NIBP), pulse oximetry will be done. All patients will receive spinal anesthesia with 3 ml 0.5% (15 mg) hyperbaric bupivacaine plus 25 μgm fentanyl at the L3/4 interspaces and the study of regional anesthetic technique will be performed postoperatively according to each group. All patients will receive postoperative analgesic regimen which is paracetamol 1gm intravenously every 8 hours and ketorolac 30mg every12 hours. Rescue analgesia in the form of 0.05 mg/kg of morphine IV will be administrated when the Numeric Rating Score (NRS) exceeding 3. The morphine dose will be repeated whenever indicated considering the total dose in the first 24 hours never exceeding 20 mg.
Measurements:
- Demographic data (age, gender, weight, ASA classification).
- Post-operative pain will be assessed by Numeric Rating Scale (NRS) from 0 to 10 at 0,2,4,6 then every 6h for 24 hours and in the second and third postoperative days at rest and during Physiotherapy.
- Postoperative analgesia, which will be assessed by total analgesic consumption, and time till administration of first rescue analgesia will be recorded.
- Effect on Motor function: by recording the mean time taken to achieve 90o active knee flexion each day till the third postoperative day.
- Adverse effects: hypotension, Bradycardia, infection, hematoma and local anesthetic toxicity will be observed and treated accordingly.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block (ACB) group | Experimental | Procedure: Adductor canal block (ACB) groupPatients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal |
| Peri-articular injection group | Experimental | Procedure: Peri-articular injection groupPatients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon. A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL |
| Adductor canal block and IPACK block group | Experimental | Procedure: Adductor canal block and IPACK block groupPatients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty
Key exclusion criteria (6 listed)
- Patient who refuse the regional anesthesia technique.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
- Patient with Advanced renal, hepatic and cardiac diseases.
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 |
|---|---|---|
| Adductor canal block (ACB) groupPatients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal | Procedure or surgery | Adductor canal block (ACB) group |
| Peri-articular injection groupPatients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon. A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL | Procedure or surgery | Peri-articular injection group |
| Adductor canal block and IPACK block groupPatients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected | Procedure or surgery | Adductor canal block and IPACK block group |
Primary outcome
Post-operative pain
Time frame: After the resolution of the effect of spinal anesthesia for 72 hours postoperative
Post-operative pain will be assessed at rest and during physiotherapy by Numeric Rating Scale from (0-10) '0' representing "no pain" to '10' representing "worst pain imaginable"
3 secondary outcomes
Postoperative analgesia
Time frame: First 24 hours postoperatively
Duration of the block
Time frame: First 24 hours postoperatively
Effect on Motor function
Time frame: Each day till the third postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No. Once the study had been successfully completed, the data will be shared for other researchers
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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.
Mohammed S Abdelghany, Lecturer principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor canal block (ACB) group, Peri-articular injection group and Adductor canal block and IPACK block group in people with Postoperative Pain and Regional Anesthesia, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: After the resolution of the effect of spinal anesthesia for 72 hours postoperative). 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 14 Oct 2021.