- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517159
Adductor Canal Block Combined With Local Infiltration Analgesia vs Local Infiltration Analgesia Alone for Postoperative Pain in Total Knee Arthroplasty (ADB_01)
Comparison of the Effect of Adductor Canal Block Combined With Local Infiltration Analgesia Versus Local Infiltration Analgesia Alone on Postoperative Pain Scores in Total Knee Arthroplasty
Total knee arthroplasty (TKA) is commonly associated with significant postoperative pain, which may impair early mobilization and functional recovery. Multimodal analgesia techniques are widely used to improve postoperative pain control while minimizing opioid consumption. Local infiltration analgesia (LIA) is a commonly used method; however, its effectiveness may be limited when used alone. The adductor canal block (ACB) provides effective analgesia while preserving quadriceps muscle strength.
This prospective randomized controlled study aims to compare the effectiveness of adductor canal block combined with local infiltration analgesia versus local infiltration analgesia alone on postoperative pain scores in patients undergoing total knee arthroplasty. The primary outcome is postoperative pain assessed using the NRS at multiple time points within the first 48 hours. Secondary outcomes include opioid consumption, functional recovery parameters and hemodynamic parameters.
The results of this study are expected to contribute to optimizing postoperative analgesia strategies in total knee arthroplasty.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total knee arthroplasty (TKA) is frequently associated with moderate to severe postoperative pain, which can negatively affect early mobilization, rehabilitation, and patient satisfaction. Effective pain management strategies are essential for enhanced recovery protocols. Multimodal analgesia has become the standard approach, combining different techniques to improve analgesic efficacy while reducing opioid-related side effects.
Local infiltration analgesia (LIA) is widely used as part of multimodal analgesia; however, it may not always provide sufficient analgesia when used alone. The adductor canal block (ACB) has gained popularity due to its ability to provide sensory blockade of the saphenous nerve while preserving quadriceps muscle strength, thus facilitating early mobilization.
This prospective randomized controlled trial was conducted to evaluate the effect of combining ACB with LIA compared to LIA alone in patients undergoing total knee arthroplasty. Patients were randomly assigned into two groups: one group received ACB combined with LIA, while the control group received LIA alone.
Postoperative pain was assessed using the Visual Analog Scale (VAS) at 2, 6, 12, 24 and 48 hours postoperatively. Secondary outcomes included total opioid consumption and functional recovery parameters. Demographic data, operative variables, and perioperative characteristics were also recorded and analyzed.
The findings of this study aim to provide evidence regarding the efficacy of combining regional anesthesia techniques with local infiltration analgesia in improving postoperative pain control following total knee arthroplasty.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
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Ankara, Ankara, Turkey (Türkiye), 06100
- Ankara University Faculty of Medicine, Ibni Sina Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 years and older
- Patients scheduled for elective total knee arthroplasty
- American Society of Anesthesiologists (ASA) physical status I-III
- Patients who provided written informed consent
Exclusion Criteria:
- Known allergy to local anesthetics
- Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
- Infection at the injection site
- Severe hepatic or renal dysfunction
- Neurological disorders affecting lower extremities
- Cognitive impairment preventing pain assessment
- Refusal to participate
- Body mass index (BMI) greater than 30 kg/m²
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACB+LIA
Patients in this group received an adductor canal block combined with local infiltration analgesia for postoperative pain management following total knee arthroplasty.
|
Ultrasound-guided adductor canal block was performed using local anesthetic to provide postoperative analgesia.
Local infiltration analgesia was administered intraoperatively using local anesthetic agents around the surgical site.
|
|
Active Comparator: LIA
Patients in this group received local infiltration analgesia alone for postoperative pain management following total knee arthroplasty.
|
Local infiltration analgesia was administered intraoperatively using local anesthetic agents around the surgical site.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain at rest (Numerating Rating Scale, NRS)
Time Frame: 2,6,12,24,48
|
Postoperative pain was assessed using the NRS at rest at predefined time points.
Postoperative pain was assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Pain scores were recorded at rest at predefined time points.
|
2,6,12,24,48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid Consumption
Time Frame: 0-48 hours postoperatively
|
Total opioid consumption within the first 48 hours postoperatively.
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0-48 hours postoperatively
|
|
Knee flexion range of motion (degrees) measured with a goniometer
Time Frame: 24 and 48 hours postoperatively
|
Functional recovery will be assessed by measuring knee flexion range of motion (degrees) using a standard goniometer at predefined postoperative time points.
|
24 and 48 hours postoperatively
|
|
Heart rate (beats per minute)
Time Frame: Baseline (preoperative) and every 15 minutes from induction of anesthesia to extubation
|
Heart rate (beats per minute) will be recorded at baseline and at 15-minute intervals from induction of anesthesia to extubation.
|
Baseline (preoperative) and every 15 minutes from induction of anesthesia to extubation
|
|
Mean arterial pressure (mmHg)
Time Frame: Baseline (before induction of anesthesia) and every 15 minutes from induction of anesthesia to extubation
|
Mean arterial pressure (mmHg) will be recorded at baseline (preoperative) and at 15-minute intervals during the intraoperative period.
|
Baseline (before induction of anesthesia) and every 15 minutes from induction of anesthesia to extubation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-349-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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