Postoperative Pain Following Knee ArthroplastyNCT07040709
Efficacy of Peripheral Nerve Blocks in Total Knee Arthroplasty
A study testing Opioid Analgesic (tramadol hydrochloride), Prophylactic analgesia (intravenous paracetamol) and Rescue analgesia (intramuscular diclofenac sodium) in people with Postoperative Pain Following Knee Arthroplasty, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
In total knee arthroplasty, the effectiveness of some peripheral nerve blocks in postoperative pain control has been investigated, with conflicting results reported. The primary aim of this study is to evaluate the effects of the suprainguinal fascia iliaca plane block, which is routinely performed in our clinic for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain Following Knee Arthroplasty
- What is being tested?
- Opioid Analgesic (tramadol hydrochloride), Prophylactic analgesia (intravenous paracetamol) and Rescue analgesia (intramuscular diclofenac sodium)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2025to 1 Mar 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 75 years
- Patients classified as ASA I, II, or III based on physical status
- Patients scheduled for total knee arthroplasty under spinal anesthesia
Who cannot join
- Patients with chronic pain conditions.
- Patients with a history of allergy to opioids or local anesthetics.
- Patients with psychiatric disorders that may impair cooperation.
- Patients with bleeding disorders or those using anticoagulant therapy.
- Patients unwilling to participate voluntarily in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, ABD Veya Kanada'daysanız Lütfen Seçin..., 60100
About this study
Official title: Investigation of the Effectiveness of Adductor Canal Block and Suprainguinal Fascia Iliaca Block in Patients Planned for Total Knee Arthroplasty
In total knee arthroplasty, the effectiveness of some peripheral nerve blocks in postoperative pain control has been investigated, with conflicting results reported. The primary aim of this study is to evaluate the effects of the suprainguinal fascia iliaca plane block, which is routinely performed in our clinic for postoperative pain management, and the adductor canal block in patients undergoing total knee arthroplasty under spinal anesthesia. Patients scheduled for total knee arthroplasty under spinal anesthesia will be randomly assigned using computer-generated randomization into two groups: the adductor canal block group (Group A) and the suprainguinal fascia iliaca plane block group (Group S). The nerve blocks will be performed by a single investigator according to the assigned group. Postoperative follow-up assessments will be conducted and recorded by a different investigator who is blinded to which nerve block was performed.
Read the detailed description
This study will be conducted on patients undergoing total knee arthroplasty with spinal anesthesia at the operating room of Gaziosmanpaşa University Research and Application Hospital. Patients aged between 18 and 75 years, with American Society of Anesthesiologists (ASA) scores of 1-3, will be included in the study. Patients with a history of chronic pain, allergy to opioids or local anesthetics, psychiatric conditions that impair cooperation, or those who do not wish to participate voluntarily will be excluded.
Patients will be randomly assigned into two groups using a computer-generated randomization: the adductor canal block group (Group A) and the suprainguinal fascia iliaca plane block group (Group S). Postoperative monitoring in the recovery unit will include non-invasive measurements of ECG, blood pressure, heart rate, and SpO2.
According to their assigned group, patients will receive either ultrasound-guided suprainguinal fascia iliaca plane block or adductor canal block for postoperative analgesia control. Patients will be observed in the recovery room for an adequate period, after which a patient-controlled analgesia (PCA) pump will be routinely applied in our clinic. The PCA will be infused with an opioid-containing solution at an appropriate dose, and detailed patient information will be provided. Instead of continuous infusion, the device will deliver bolus doses intermittently when the patient's numeric rating scale (NRS) score reaches 4 or higher. If the patient's pain score remains 4 or above despite analgesic administration, routine intramuscular dicloron as rescue analgesia will be administered in our clinic. Patients will be periodically visited in bed, and data will be recorded regarding pain scores, motor strength of the operated limb, opioid consumption, use of rescue analgesia, and any complications. Follow-up assessments will be performed by a single experienced Anesthesiology and Reanimation specialist.
- Being tested
- Opioid Analgesic (tramadol hydrochloride), Prophylactic analgesia (intravenous paracetamol), Rescue analgesia (intramuscular diclofenac sodium)
- Keywords
- Knee Replacement Arthroplasty, Postoperative Pain, Nerve Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Analgesic (tramadol hydrochloride)Other
For postoperative pain management, a patient-controlled analgesia (PCA) pump will be routinely applied to the patient in our clinic. An infusion of an opioid (tramadol hydrochloride) at an appropriate dose will be administered via intravenous route through the pump, and the patient will be provided with detailed information about its use. Instead of continuous infusion, the device will deliver intermittent bolus doses when the patient's numeric rating scale (NRS) score is 4 or higher.
Prophylactic analgesia (intravenous paracetamol)Other
All patients will receive routine prophylactic analgesia with 1 gram of intravenous paracetamol every 6 hours (which may be skipped if the patient's pain score is 2 or below and they do not request pain relief).
Rescue analgesia (intramuscular diclofenac sodium)Other
If the pain persists despite the administered analgesics and the patient's pain score remains 4 or above, rescue analgesia with intramuscular diclofenac sodium, which is routinely used in our clinic, will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | A patient who underwent total knee arthroplasty under spinal anesthesia will receive an adductor canal block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption. Receives: Other: Opioid Analgesic (tramadol hydrochloride); Other: Prophylactic analgesia (intravenous paracetamol); Other: Rescue analgesia (intramuscular diclofenac sodium) |
| Group S | Active comparator | A patient who underwent total knee arthroplasty under spinal anesthesia will receive an suprainguinal fascia iliac plane block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption. Receives: Other: Opioid Analgesic (tramadol hydrochloride); Other: Prophylactic analgesia (intravenous paracetamol); Other: Rescue analgesia (intramuscular diclofenac sodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
Numeric Rating Scale (NRS), is a simple and widely used tool for patients to rate their pain intensity. It typically involves asking the patient to select a number from 0 to 10, where: 0 indicates no pain at all, 10 represents the worst pain imaginable.
Measured: Postoperative patients will be visited and their pain scores will be evaluated at 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours
Secondary outcomes (2)
Total opioid consumption
Total amount of opioid (tramadol hydrochloride) consumed via intravenous route within the 24 hours postoperatively with a controlled pain pump.
Measured: The total amount of administered opioid (tramadol hydrochloride) within the first 24 hours postoperatively.
The patient's knee extension capability
The patient's knee extension capability is classified as follows:
0: Normal strength, the patient can fully extend the knee with normal force.
1: The patient can extend the knee beyond gravity's effect but cannot overcome resistance.
3: Paralysis; the patient is unable to extend the knee.
Measured: Postoperative patients will be visited and their knee extension capability will be evaluated at 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start8 Jun 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Following Knee ArthroplastyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing total knee arthroplasty under spinal anesthesia will be randomly assigned by computer-generated randomization into one of two groups: the adductor canal block group (Group A) or the suprainguinal fascia iliaca plane block group (Group S). After the surgical procedure, depending on the assigned group, the postoperative analgesia will be managed with ultrasound-guided suprainguinal fascia iliaca plane block or adductor canal block.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Genc, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040709
- Sponsor's protocol ID
- 24-AKD-143
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Adductor Canal Block and Suprainguinal Fascia Iliaca Block in Patients Planned for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07040709
- Acronym / sponsor ID
- 24-AKD-143
- Keywords
- Knee Replacement Arthroplasty, Postoperative Pain, Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 8 Jun 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 27 Jun 2025 (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.
In total knee arthroplasty, the effectiveness of some peripheral nerve blocks in postoperative pain control has been investigated, with conflicting results reported. The primary aim of this study is to evaluate the effects of the suprainguinal fascia iliaca plane block, which is routinely performed in our clinic for postoperative pain management, and the adductor canal block in patients undergoing total knee arthroplasty under spinal anesthesia. Patients scheduled for total knee arthroplasty under spinal anesthesia will be randomly assigned using computer-generated randomization into two groups: the adductor canal block group (Group A) and the suprainguinal fascia iliaca plane block group (Group S). The nerve blocks will be performed by a single investigator according to the assigned group. Postoperative follow-up assessments will be conducted and recorded by a different investigator who is blinded to which nerve block was performed.
Detailed description
This study will be conducted on patients undergoing total knee arthroplasty with spinal anesthesia at the operating room of Gaziosmanpaşa University Research and Application Hospital. Patients aged between 18 and 75 years, with American Society of Anesthesiologists (ASA) scores of 1-3, will be included in the study. Patients with a history of chronic pain, allergy to opioids or local anesthetics, psychiatric conditions that impair cooperation, or those who do not wish to participate voluntarily will be excluded.
Patients will be randomly assigned into two groups using a computer-generated randomization: the adductor canal block group (Group A) and the suprainguinal fascia iliaca plane block group (Group S). Postoperative monitoring in the recovery unit will include non-invasive measurements of ECG, blood pressure, heart rate, and SpO2.
According to their assigned group, patients will receive either ultrasound-guided suprainguinal fascia iliaca plane block or adductor canal block for postoperative analgesia control. Patients will be observed in the recovery room for an adequate period, after which a patient-controlled analgesia (PCA) pump will be routinely applied in our clinic. The PCA will be infused with an opioid-containing solution at an appropriate dose, and detailed patient information will be provided. Instead of continuous infusion, the device will deliver bolus doses intermittently when the patient's numeric rating scale (NRS) score reaches 4 or higher. If the patient's pain score remains 4 or above despite analgesic administration, routine intramuscular dicloron as rescue analgesia will be administered in our clinic. Patients will be periodically visited in bed, and data will be recorded regarding pain scores, motor strength of the operated limb, opioid consumption, use of rescue analgesia, and any complications. Follow-up assessments will be performed by a single experienced Anesthesiology and Reanimation specialist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients undergoing total knee arthroplasty under spinal anesthesia will be randomly assigned by computer-generated randomization into one of two groups: the adductor canal block group (Group A) or the suprainguinal fascia iliaca plane block group (Group S). After the surgical procedure, depending on the assigned group, the postoperative analgesia will be managed with ultrasound-guided suprainguinal fascia iliaca plane block or adductor canal block.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Opioid Analgesic (tramadol hydrochloride), Other: Prophylactic analgesia (intravenous paracetamol), Other: Rescue analgesia (intramuscular diclofenac sodium)A patient who underwent total knee arthroplasty under spinal anesthesia will receive an adductor canal block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption. |
| Group S | Active comparator | Other: Opioid Analgesic (tramadol hydrochloride), Other: Prophylactic analgesia (intravenous paracetamol), Other: Rescue analgesia (intramuscular diclofenac sodium)A patient who underwent total knee arthroplasty under spinal anesthesia will receive an suprainguinal fascia iliac plane block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 75 years
- Patients classified as ASA I, II, or III based on physical status
- Patients scheduled for total knee arthroplasty under spinal anesthesia
Key exclusion criteria (5 listed)
- Patients with chronic pain conditions.
- Patients with a history of allergy to opioids or local anesthetics.
- Patients with psychiatric disorders that may impair cooperation.
- Patients with bleeding disorders or those using anticoagulant therapy.
- Patients unwilling to participate voluntarily in the study.
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 |
|---|---|---|
| Opioid Analgesic (tramadol hydrochloride)For postoperative pain management, a patient-controlled analgesia (PCA) pump will be routinely applied to the patient in our clinic. An infusion of an opioid (tramadol hydrochloride) at an appropriate dose will be administered via intravenous route through the pump, and the patient will be provided with detailed information about its use. Instead of continuous infusion, the device will deliver intermittent bolus doses when the patient's numeric rating scale (NRS) score is 4 or higher. | Other | Group A, Group S |
| Prophylactic analgesia (intravenous paracetamol)All patients will receive routine prophylactic analgesia with 1 gram of intravenous paracetamol every 6 hours (which may be skipped if the patient's pain score is 2 or below and they do not request pain relief). | Other | Group A, Group S |
| Rescue analgesia (intramuscular diclofenac sodium)If the pain persists despite the administered analgesics and the patient's pain score remains 4 or above, rescue analgesia with intramuscular diclofenac sodium, which is routinely used in our clinic, will be administered. | Other | Group A, Group S |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: Postoperative patients will be visited and their pain scores will be evaluated at 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours
Numeric Rating Scale (NRS), is a simple and widely used tool for patients to rate their pain intensity. It typically involves asking the patient to select a number from 0 to 10, where: 0 indicates no pain at all, 10 represents the worst pain imaginable.
2 secondary outcomes
Total opioid consumption
Time frame: The total amount of administered opioid (tramadol hydrochloride) within the first 24 hours postoperatively.
The patient's knee extension capability
Time frame: Postoperative patients will be visited and their knee extension capability will be evaluated at 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th 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 26 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Analgesic (tramadol hydrochloride), Prophylactic analgesia (intravenous paracetamol) and Rescue analgesia (intramuscular diclofenac sodium) in people with Postoperative Pain Following Knee Arthroplasty, run by Tokat Gaziosmanpasa University 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 5 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 26 Jun 2026. 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?
Numeric Rating Scale (NRS) (time frame: Postoperative patients will be visited and their pain scores will be evaluated at 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th 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 26 Jun 2026.