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Osteoarthrosis Knee Arthroplasty Analgesia Pain ManagementACBNCT06533085

Comparison Ultrasound-Guided Adductor Canal Block and Surgeon-Performed Block for Pain Management After Total Knee Arthroplasty

A study testing Adductor canal block by surgeon in people with Osteoarthrosis Knee Arthroplasty Analgesia Pain Management, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: Adductor canal block (ACB) is widely performed for postoperative analgesia for total knee arthroplasty (TKA). The aim of this study is to compare surgeon-assisted and anesthesiologist-assisted (ultrasound-guided) adductor blocks in terms of postoperative analgesic efficacy. Read more about this study

Who is it for?
Ages 40 to 90 yearsHealthy volunteers can take part
What is being tested?
Adductor canal block by surgeon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2021to 30 May 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 40 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Performing total knee joint arthroplasty due to stage 4 gonarthrosis
  • Agree to participate in the study
  • Having signed the informed consent form

Who cannot join

  • The following were excluded from the study: refusal to participate
  • Underwent revision TKA,
  • Allergy to any of the painkillers used,
  • Contraindication to regional or spinal anesthesia,
  • Use of narcotic painkillers prior to surgery,
  • Sensory or motor neuropathy,
  • Cirrhosis of the liver,
  • Chronic renal failure

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ahievran university

    Kirşehi̇r, 40100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison Ultrasound-Guided Adductor Canal Block and Surgeon-Performed Block for Pain Management After Total Knee Arthroplasty: A Prospective Randomized Controlled Study

Objective: Adductor canal block (ACB) is widely performed for postoperative analgesia for total knee arthroplasty (TKA). The aim of this study is to compare surgeon-assisted and anesthesiologist-assisted (ultrasound-guided) adductor blocks in terms of postoperative analgesic efficacy.

Methods: This study was designed as a double-blind, prospective and randomized trial. A total of 240 participants were randomly allocated to three groups: one where the surgeon performed the adductor canal block (ACBs), another where it was conducted by an anesthetist with ultrasound guidance (ACBa), and a third group without the adductor block. The follow-up management after the Total Knee Arthroplasty (TKA) procedure occurred on the first, third, and tenth days, as well as the twelfth week. Outcome measures comprised pain assessment using the Visual Analog Scale (VAS) and monitoring opioid analgesic consumption.

Read the detailed description
  1. Introduction In advanced stages of osteoarthritis (OA) of knee, one of major option of treatment is total knee arthroplasty (TKA). Approximately 20% of individuals who undergo TKA experience a loss of physical function, primarily due to the variable intensity of post-operative pain. The risk of thromboembolism due to ambulation limitations and immobility increases along with pain . Various approaches have been proposed to manage post-operative pain. Three distinct regimens have been developed to control pain that develops after TKA. These can be pre-operative, intraoperative, and post-operative analgesic regimens . The main component of the pre-operative regimen is opioids. Local infiltration analgesic regimens are considered in the intraoperative regime, while peripheral nerve blocks are examined in the post-operative analgesic regime . Opioids are effective in pain management, yet they come with limited side effects . Local infiltration anesthesia administration is straightforward and carries a low risk of systemic toxicity . While various methods exist, the posterior capsule is a commonly targeted administration site. Adductor canal block (ACB) can be performed pre-operatively, intraoperatively, or post-operatively. The motor branches of the femoral nerve are preserved while blocking the saphenous nerve, and quadriceps muscle strength is minimally affected. Hospital stay is shortened. ACB is becoming increasingly popular due to these advantages. ACB is routinely performed with ultrasound (USG) pre-operatively or post-operatively. In addition, intraoperative ACB performed by the surgeon has recently been introduced. One of the techniques utilized to alleviate post-operative pain is known as posterior capsular infiltration analgesia (PCI). In PCI, local sensory nerve endings are targeted. PCI preserves muscle strength and does not negatively impact functional recovery. The objective of this study is to compare postoperative pain among knee prosthesis patients who undergo adductor canal block (ACBa) performed by an anesthetist using ultrasound guidance, ACB (ACBs) performed intraoperatively by the surgeon, and those without ACB.
  2. Materials and Methods This study has been designed in a double-blind, randomized, controlled trial format. The study included 255 participants diagnosed with knee osteoarthritis and underwent TKA surgery between May 2021 and May 2022 at our university hospital. The sample size for the study was determined through a power analysis. Based on power analysis for the F-test with a Type I error rate of 0.05, a 95% confidence interval, and a Type II error rate of 0.10, the requisite total sample size is determined to be 207 subjects (equating to 69 patients per group). Owing to the potential employment of non-parametric tests within the analyses, it is recommended to augment the sample size by 15%. Consequently, the calculated sample size necessary is established at 240 subjects (thereby requiring 80 patients per group). This study will be conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval for the study was been obtained from the ethics committee of the institution where the researchers are employed (Kirsehir Ahi Evran University, Faculty of Medicine Ethics Committee, IRB approval number: 2022-08/89). Participation was voluntary. Informed consent was obtained from the participants, indicating that their information would be used in the study, but their identities would remain confidential.

Physical examinations were repeated on participants before the surgery, and pre-operative anesthesia examinations were conducted. At this stage, the acceptance criteria for the participants were evaluated. Inclusion criteria were defined as end stage (Kellgren-Lawrence grade 4) knee osteoarthritis, treated with primary TKA and willing to participate the study. The following were excluded from the study: refusal to participate, underwent revision TKA, allergy to any of the painkillers used, contraindication to regional or spinal anesthesia, use of narcotic painkillers prior to surgery, sensory or motor neuropathy, cirrhosis of the liver, chronic renal failure. The study was continued with 240 participants after excluding those who did not meet the criteria. The participants were randomly divided into three groups, one being the control group. Figure 1 shows the Consolidated Standards of Reporting Trials (CONSORT) diagram.

A computer-generated randomized list was generated from which participants were randomly allocated to one of the three study groups in a 1:1:1 allocation ratio. Adductor canal block plus posterior capsular infiltration analgesia was performed intra-operatively by the surgeon using anatomical landmarks, and no additional imaging was performed (ACBs). Adductor canal block plus posterior capsular infiltration analgesia was performed post-operatively by a specialist in anesthesiology with the help of ultrasound (ACBa). Finally, a control group underwent PCI only. Patients were evaluated postoperatively by different authors for double-blind.

Participants and the surgeons conducting pre-operative and post-operative assessments need to be made aware of the group to which the patient belongs. The surgeon performing the operation is distinct from the one conducting the assessment.

All participants underwent surgery by a single senior surgeon, under spinal anesthesia performed by a single experienced anesthesiologist. The participants were prepared for the operation by applying lateral support in the supine position under spinal anesthesia. Following the administration of spinal anesthesia, a dose of 10 mg/kg of tranexamic acid was administered intravenously to each patient before the commencement of the surgical procedure. The surgical procedure involved a standard midline skin incision followed by a medial parapatellar arthrotomy. Subsequently, standard tibial and femoral osteotomies were performed with the use of a tourniquet during implant cementation. The Genesis II (Smith \& Nephew, Memphis, TN) primary posterior-stabilized implant was utilised. The tourniquet was inflated at the stage when the cuts were completed and the washing procedure began. The implant was then performed, the cement reaction was completed, and the tourniquet cuff was lowered. Total knee arthroplasty with a tourniquet and cement was used in all participants.

Three groups were evaluated in the study. All three groups underwent intraoperative PCI.

Group 1 (Adductor canal block by surgeon): The method described by Pepper et al. was employed. Accordingly, the anatomical landmarks were first determined by the surgeon post-implantation. The medial femoral cavity was dissected with finger dissection. The vastus medialis obliquus muscle was dissected laterally. The needle was advanced posterior-superiorly by resting it on the anteromedial aspect of the femur at a 45° angle, approximately four finger breadths (7 cm) proximal to the joint line. It was ensured that the needle was not within an artery, and a 22G 10 cm needle was used to inject 7 ml of 0.5% bupivacaine + 8 ml of 0.9% saline. No additional peri-articular injection was performed (Figure 2).

Group 2 (Adductor canal block by anesthesiology specialist ): This method was performed post-operatively right after the surgery was over. The anesthesiologist used an ultrasound-guided technique without a stimulator aid to apply the adductor canal block. While the patient was supine, the leg position was done with a slight external thigh rotation. After proper positioning, the skin was prepared with an iodine solution, and a sterile technique was used. For block performance, a 22-gauge 100 mm needle and linear ultrasound probe were chosen. Our target zone for the adductor canal block was the inner mid-thigh, where the vasoadductor membrane can be seen on the medial border of the vastus medialis muscle and the lateral side of the femoral artery. Sartorius muscle was seen anterior to all three of those structures. After ultrasonography visualization of the vasoadductor membrane, the needle was targeted to the membranous structure beside the femoral artery. A mixture of 7 ml 0.5% bupivacaine with 8 ml of %0.9 isotonic saline solution was injected slowly into the particular area as peri-articular filling lateral to the femoral artery was seen (Figure 3).

Group 3 (Control group): The posterior capsular infiltration analgesia procedure was performed following irrigation procedures before implantation. The PCI procedure involves injecting 20 mL of the PCI cocktail (consisting of 0.2% ropivacaine and 2.0 mg/mL epinephrine) into the posterior aspect of the capsule through the intercondylar space of the femur. The PCI cocktail was prepared by an anesthesiologist who was not a part of the study (Figure 4).

Postoperative rehabilitation and management: Continuous physical therapy was conducted to measure the patient's endurance at certain movement degrees. The device was set at 45° on the first day after surgery, and rehabilitation began. Those who tolerated rehabilitation for 60 minutes were gradually increased to 75°, 90°, 105°, and 120°. On the first day, a maximum of 90° was allowed, and on the second day, the 105° and 120° were moved to those who tolerated it. The angle the participants could tolerate and how long was recorded on the 1st, second, and third days. Metamizole sodium 500 mg/dose every 6 hours intravenously, celecoxib (orally, once daily, 400 mg per dose), paracetamol (oral, four times daily, 500 mg per dose), pregabalin (orally, once daily, 75 mg per dose) were given for postoperative pain management. Patient with persisted paint or could not tolerate rehabilitation, single dose (2 ml) containing 100 mg of tramadol hydrochloride was administered.

Examined Variables: The participants' age, gender, body mass index, and the side of the operation were examined. The participants' need and consumption of opioids. (One ampoule (2 ml) contains 100 mg of tramadol hydrochloride. Range of motion (ROM) was measured pre-operatively and 12th week post-operatively. The Knee Society Score (KSS) and the Oxford Knee Score (OKS) were also measured preoperatively and at 12 weeks post-operatively to assess functional status. VAS scores were recorded for the participants before surgery and at 3 h, 12 h, first day, 3 days, 10 days and 12 weeks after surgery.

Being tested
Adductor canal block by surgeon
Keywords
Knee Arthroplasty Pain Adductor Canal Block analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adductor canal block by surgeonProcedure or surgery

    Also called Adductor canal block by anesthesiology specialist

    Three groups were evaluated in the study. All three groups underwent intraoperative PCI.

    Group 1 (Adductor canal block by surgeon) Group 2 (Adductor canal block by anesthesiology specialist ) Group 3 (Control group)

Study groups in NCT06533085
Study groupRoleWhat they receive
Adductor canal block by surgeonActive comparatorThe method described by Pepper et al. was employed [20]. Accordingly, the anatomical landmarks were first determined by the surgeon post-implantation. The medial femoral cavity was dissected with finger dissection. The vastus medialis obliquus muscle was dissected laterally. The needle was advanced posterior-superiorly by resting it on the anteromedial aspect of the femur at a 45° angle, approximately four finger breadths (7 cm) proximal to the joint line. It was ensured that the needle was not within an artery, and a 22G 10 cm needle was used to inject 7 ml of 0.5% bupivacaine + 8 ml of 0.9% saline. No additional peri-articular injection was performed
Receives: Procedure: Adductor canal block by surgeon
Adductor canal block by anesthesiology specialistActive comparatorThe anesthesiologist used an ultrasound-guided technique without a stimulator aid to apply the adductor canal block. While the patient was supine, the leg position was done with a slight external thigh rotation.Our target zone for the adductor canal block was the inner mid-thigh, where the vasoadductor membrane can be seen on the medial border of the vastus medialis muscle and the lateral side of the femoral artery. After ultrasonography visualization of the vasoadductor membrane, the needle was targeted to the membranous structure beside the femoral artery. A mixture of 7 ml 0.5% bupivacaine with 8 ml of %0.9 isotonic saline solution was injected slowly into the particular area as peri-articular filling lateral to the femoral artery was seen
Receives: Procedure: Adductor canal block by surgeon
Control groupActive comparatorThe posterior capsular infiltration analgesia procedure was performed following irrigation procedures before implantation. The PCI procedure involves injecting 20 mL of the PCI cocktail (consisting of 0.2% ropivacaine and 2.0 mg/mL epinephrine) into the posterior aspect of the capsule through the intercondylar space of the femur. The PCI cocktail was prepared by an anesthesiologist who was not a part of the study
Receives: Procedure: Adductor canal block by surgeon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

    Measured: immediately before surgery and postoperative at hour 3, postoperative at hour 12, postoperative day 1, postoperative day 3, postoperative day 10 and week 12 after surgery.

  2. Pain Managment

    consumption of opioids (single dose (2 ml) containing 100 mg of tramadol hydrochloride was administered)

    Measured: Postoperative Day 1 Opioid Usage, Postoperative Day 2 Opioid Usage, Postoperative Day 3 Opioid Usage

Secondary outcomes (1)
  1. Functionality

    Knee scoiety score(KSS) (The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.Turkish validity and reliability has been established.)

    Measured: preoperatively and at week 12 post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start1 May 2021
  3. Primary completion15 May 2022
  4. Study completion30 May 2022

Resources

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
randomized controlled study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06533085
Sponsor's protocol ID
2022-08/89
Acronym
ACB
Status last verified
Jul 2024
First submitted
24 Jul 2024
Last updated
1 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cakmak MF, Horoz L, Arslan FN, Demir OU, Basarir K. Comparison ultrasound-guided adductor canal block and surgeon-performed block for pain management after total knee arthroplasty: a prospective randomized controlled study. BMC Musculoskelet Disord. 2024 Aug 10;25(1):637. doi: 10.1186/s12891-024-07762-x.

    PubMed 39127622

Questions about this trial

What is this clinical trial studying?

A study testing Adductor canal block by surgeon in people with Osteoarthrosis Knee Arthroplasty Analgesia Pain Management, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

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: finished, as of the sponsor's last update on 1 Aug 2024. 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 Turkey (Türkiye). 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?

Pain Intensity (time frame: immediately before surgery and postoperative at hour 3, postoperative at hour 12, postoperative day 1, postoperative day 3, postoperative day 10 and week 12 after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06533085, which also lists 1 linked publication.

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 1 Aug 2024.

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