Rheumatism KneeNCT04986878
Single Shot Versus Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty
A study testing single-shot adductor canal block in people with Rheumatism Knee, run by Aswan University Hospital at 2 sites in Egypt.
Trial summary
Adductor canal block (ACB) has emerged as an option for postoperative regional analgesia in patients undergoing total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatism Knee
- What is being tested?
- single-shot adductor canal block
- 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
- 2 sitesEgypt
- Study dates
- 15 Mar 2017to 30 Jun 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for primary total knee arthroplasty with
- American Society of Anesthesiologists (ASA) physical status I -III,
- mentally competent and able to give consent for enrollment in the study.
Who cannot join
- Patient younger than 18 years old or older than 70 years old
- Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol.
- Revision surgeries were excluded.
- Impaired kidney functions and patients with coagulopathy were also excluded.
- Chronic pain syndromes and patients with chronic opioid use defined as the use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery.
- BMI of 40 or more
- Pregnancy (positive urine pregnancy test result in Preop area on the morning of surgery)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Comparison Between the Analgesic Effects of Single Shot Versus Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty
Adductor canal block (ACB) has emerged as an option for postoperative regional analgesia in patients undergoing total knee arthroplasty (TKA).
Read the detailed description
Various approaches to the performance of peripheral nerve blocks for postoperative pain control in patients undergoing TKA have been described in the literature. These approaches include lumbar plexus block, femoral nerve block (FNB), with or without a sciatic nerve block, and most recently the ACB. FNB is a commonly used modality for postoperative analgesia after TKA. It is considered by some as the gold standard or the cornerstone of postoperative analgesia after TKA. However, FNB reduces quadriceps muscle strength essential for mobilization and active contribution in any physical rehabilitation program. Quadriceps weakness places the patients at risk of falling. which may be detrimental to postoperative recovery. The ACB has recently emerged as an appealing alternative to FNB as it is predominately a sensory nerve block of a more distal branch of the femoral nerve ( the saphenous nerve).
- Conditions
- Rheumatism Knee
- Being tested
- single-shot adductor canal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-shot adductor canal blockProcedure or surgery
Also called Saphenous nerve block
An ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe was used to perform the adductor canal block immediately postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Single shot adductor canal block | Active comparator | Following sterile preparation and draping, an ultrasound survey of the medial thigh was performed, halfway between the superior anterior iliac spine and the patella. The superficial femoral artery has been identified beneath the sartorius muscle in a short-axis view, with the vein just inferior and the saphenous nerve just lateral to the artery. A 20 Gauge, 120 mm, non-cuttings tip echogenic needle (SonoPlex STIM, Germany) needle was introduced in-plane, and 2 to 3 mL of LA bolus (0.25 % Bupivacaine) was used to confirm proper needle placement in the adductor canal near the saphenous nerve. Then, a bolus of 20 ml of Bupivacaine 0.25 % was injected through the needle Receives: Procedure: single-shot adductor canal block |
| Continuous adductor canal block | Active comparator | a catheter was secured in place using Tegaderm. The catheters were connected to a pump that infused local anesthetic, 20 mL of 0.25 % bupivacaine, followed by 48 hours of continuous infusion of 0.125 % bupivacaine at 5 mL/h. Receives: Procedure: single-shot adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain scores by visual analogue score
visual analogue score is a straight, vertical 10-cm line with the bottom point representing "no pain" = (0cm) and the top point representing "the worst pain you could ever have" = (10 cm).
Measured: 48 hours
Secondary outcomes (3)
time to up and go test (minutes)
determines how long it takes a person to get out of a chair
Measured: 48 hours
six-minute walking test
calculates the distance that can be walked in 6 minutes
Measured: 48 hours
the 30-Second Chair test
determines how many times a person can rise from a chair and sit down again in 30 seconds while keeping their arms crossed over their chest
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start15 Mar 2017
- Primary completion31 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatism KneeStudies of the same condition, open and under way.
- 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
- Model description
- The target population of this study will be patients undergoing primary total knee arthroplasty at Aswan l and Assiut university hospitals
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Fahmy Mahmoud, PhD, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986878
- Sponsor's protocol ID
- 24-10-15
- Status last verified
- Aug 2021
- First submitted
- 30 Jun 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Analgesic Effects of Single Shot Versus Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04986878
- Acronym / sponsor ID
- 24-10-15
- Conditions
- Rheumatism Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 3 Aug 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.
Adductor canal block (ACB) has emerged as an option for postoperative regional analgesia in patients undergoing total knee arthroplasty (TKA).
Detailed description
Various approaches to the performance of peripheral nerve blocks for postoperative pain control in patients undergoing TKA have been described in the literature. These approaches include lumbar plexus block, femoral nerve block (FNB), with or without a sciatic nerve block, and most recently the ACB. FNB is a commonly used modality for postoperative analgesia after TKA. It is considered by some as the gold standard or the cornerstone of postoperative analgesia after TKA. However, FNB reduces quadriceps muscle strength essential for mobilization and active contribution in any physical rehabilitation program. Quadriceps weakness places the patients at risk of falling. which may be detrimental to postoperative recovery. The ACB has recently emerged as an appealing alternative to FNB as it is predominately a sensory nerve block of a more distal branch of the femoral nerve ( the saphenous nerve).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The target population of this study will be patients undergoing primary total knee arthroplasty at Aswan l and Assiut university hospitals
| Arm | Type | Receives |
|---|---|---|
| Single shot adductor canal block | Active comparator | Procedure: single-shot adductor canal blockFollowing sterile preparation and draping, an ultrasound survey of the medial thigh was performed, halfway between the superior anterior iliac spine and the patella. The superficial femoral artery has been identified beneath the sartorius muscle in a short-axis view, with the vein just inferior and the saphenous nerve just lateral to the artery. A 20 Gauge, 120 mm, non-cuttings tip echogenic needle (SonoPlex STIM, Germany) needle was introduced in-plane, and 2 to 3 mL of LA bolus (0.25 % Bupivacaine) was used to confirm proper needle placement in the adductor canal near the saphenous nerve. Then, a bolus of 20 ml of Bupivacaine 0.25 % was injected through the needle |
| Continuous adductor canal block | Active comparator | Procedure: single-shot adductor canal blocka catheter was secured in place using Tegaderm. The catheters were connected to a pump that infused local anesthetic, 20 mL of 0.25 % bupivacaine, followed by 48 hours of continuous infusion of 0.125 % bupivacaine at 5 mL/h. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for primary total knee arthroplasty with
- American Society of Anesthesiologists (ASA) physical status I -III,
- mentally competent and able to give consent for enrollment in the study.
Key exclusion criteria (7 listed)
- Patient younger than 18 years old or older than 70 years old
- Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol.
- Revision surgeries were excluded.
- Impaired kidney functions and patients with coagulopathy were also excluded.
- Chronic pain syndromes and patients with chronic opioid use defined as the use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery.
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 |
|---|---|---|
| single-shot adductor canal blockAlso: Saphenous nerve blockAn ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe was used to perform the adductor canal block immediately postoperatively. | Procedure or surgery | Continuous adductor canal block, Single shot adductor canal block |
Primary outcome
postoperative pain scores by visual analogue score
Time frame: 48 hours
visual analogue score is a straight, vertical 10-cm line with the bottom point representing "no pain" = (0cm) and the top point representing "the worst pain you could ever have" = (10 cm).
3 secondary outcomes
time to up and go test (minutes)
Time frame: 48 hours
six-minute walking test
Time frame: 48 hours
the 30-Second Chair test
Time frame: 48 hours
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 4 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-shot adductor canal block in people with Rheumatism Knee, run by Aswan University Hospital at 2 sites 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 3 inclusion and 7 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
postoperative pain scores by visual analogue score (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 4 Aug 2021.