Knee Arthroplasty, TotalNCT07526831
Comparison of the Analgesic Efficacy of Adductor Canal Block and Combined Adductor Canal Block Plus IPACK Block in Knee Surgery
An observational study of Knee Arthroplasty, Total, run by TC Erciyes University at 2 sites in Turkey (Türkiye).
Trial summary
To evaluate the effectiveness of Adductor Canal Block and combined Adductor Canal plus IPACK block in reducing postoperative pain and analgesic requirements in patients undergoing knee surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Adductor Canal Block Group (Group I) and Adductor Canal + iPACK Block Group (Group II)"
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥18 years, classified as ASA physical status I-III, scheduled to undergo total knee arthroplasty.
Who may be able to join
- ASA (American Society of Anesthesiologists) I- ASA II-ASA III Patients
Who cannot join
- history of allergy to the study medication
- refusal to participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Sibel Pehlivan
Kayseri, Talas, 38090
Sibel PEHLIVAN, MD, 05052532919, sibelpehlivan@erciys:edu.tr
- Recruiting
Sibel Seckin Pehlivan
Kayseri, 38039
Sibel Seçkin Pehlivan, 05052532919, sibelpehlivan@erciys:edu.tr
About this study
Official title: Comparison of the Analgesic Efficacy of Adductor Canal Block Versus Adductor Canal Block Combined With Local Anesthetic Infiltration Between the Popliteal Artery and the Capsule of the Knee (IPACK) in Patients Undergoing Knee Surgery
To evaluate the effectiveness of Adductor Canal Block and combined Adductor Canal plus IPACK block in reducing postoperative pain and analgesic requirements in patients undergoing knee surgery.
Read the detailed description
In total knee arthroplasty, ultrasound-guided Adductor canal block or Adductor Canal block combined with local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) will provide adequate postoperative analgesia.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Adductor Canal Block Group (Group I), Adductor Canal + iPACK Block Group (Group II)"
- Keywords
- ultrasound, IPACK block, Adductor Canal Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal Block Group (Group I)Procedure or surgery
All patients in Group I will receive a preoperative adductor canal block. In all groups, an intravenous patient-controlled analgesia device containing morphine will be administered for postoperative pain management.
Adductor Canal + iPACK Block Group (Group II)"Procedure or surgery
All patients in Group II will receive a preoperative adductor canal block combined with an iPACK block. Postoperatively, all patients in both groups will be provided with intravenous patient-controlled analgesia containing morphine for pain management.
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block group(ACB) | Patients in the ACB group (Group I) will receive a single-shot adductor canal block under ultrasound guidance bupivacaine administered preoperatively. Receives: Procedure: Adductor Canal Block Group (Group I) | |
| Adductor canal + iPACK block group(ACB+IPACK) | Patients in the ACB + iPACK group (Group II) will receive a single-shot adductor canal block combined with an infiltration between the popliteal artery and the capsule of the knee (iPACK) under ultrasound guidance bupivacaine. Receives: Procedure: Adductor Canal + iPACK Block Group (Group II)" |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 4 mg 1 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Measured: 24 hours after surgery
Verbal analog Pain Scores on rest and movement
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
Measured: 24 hours after surgery
Secondary outcomes (1)
incidences of adverse effects (like nausea and vomiting)
incidences of nausea and vomiting during the 24 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24 hours).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Apr 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Seçkin Pehlivan, TC Erciyes University
- Investigators
- Sibel Pehlivan, Study director, Erciyes Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526831
- Sponsor's protocol ID
- 2026\115
- Status last verified
- May 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Shoni M, Samineni AV, Salavati S, Mikkilineni N, Wang A, Abdeen A, Freccero D. Combined Single-Shot Infiltration Between the Popliteal Artery and Capsule of the Knee and Adductor Canal Block With Bupivacaine, Dexmedetomidine, and Dexamethasone for Total Knee Arthroplasty: A Propensity-Matched Analysis. Arthroplast Today. 2023 Dec 28;25:101292. doi: 10.1016/j.artd.2023.101292. eCollection 2024 Feb.
PubMed 38235397Mariano ER, Kim TE, Wagner MJ, Funck N, Harrison TK, Walters T, Giori N, Woolson S, Ganaway T, Howard SK. A randomized comparison of proximal and distal ultrasound-guided adductor canal catheter insertion sites for knee arthroplasty. J Ultrasound Med. 2014 Sep;33(9):1653-62. doi: 10.7863/ultra.33.9.1653.
PubMed 25154949
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Efficacy of Adductor Canal Block Versus Adductor Canal Block Combined With Local Anesthetic Infiltration Between the Popliteal Artery and the Capsule of the Knee (IPACK) in Patients Undergoing Knee Surgery
- ClinicalTrials.gov ID
- NCT07526831
- Acronym / sponsor ID
- 2026\115
- Conditions
- Knee Arthroplasty, Total
- Keywords
- ultrasound, IPACK block, Adductor Canal Block
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
To evaluate the effectiveness of Adductor Canal Block and combined Adductor Canal plus IPACK block in reducing postoperative pain and analgesic requirements in patients undergoing knee surgery.
Detailed description
In total knee arthroplasty, ultrasound-guided Adductor canal block or Adductor Canal block combined with local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) will provide adequate postoperative analgesia.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block group(ACB) | – | Procedure: Adductor Canal Block Group (Group I)Patients in the ACB group (Group I) will receive a single-shot adductor canal block under ultrasound guidance bupivacaine administered preoperatively. |
| Adductor canal + iPACK block group(ACB+IPACK) | – | Procedure: Adductor Canal + iPACK Block Group (Group II)"Patients in the ACB + iPACK group (Group II) will receive a single-shot adductor canal block combined with an infiltration between the popliteal artery and the capsule of the knee (iPACK) under ultrasound guidance bupivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years, classified as ASA physical status I-III, scheduled to undergo total knee arthroplasty.
Key inclusion criteria (1 listed)
- ASA (American Society of Anesthesiologists) I- ASA II-ASA III Patients
Key exclusion criteria (2 listed)
- history of allergy to the study medication
- refusal to participate
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 Group (Group I)All patients in Group I will receive a preoperative adductor canal block. In all groups, an intravenous patient-controlled analgesia device containing morphine will be administered for postoperative pain management. | Procedure or surgery | Adductor canal block group(ACB) |
| Adductor Canal + iPACK Block Group (Group II)"All patients in Group II will receive a preoperative adductor canal block combined with an iPACK block. Postoperatively, all patients in both groups will be provided with intravenous patient-controlled analgesia containing morphine for pain management. | Procedure or surgery | Adductor canal + iPACK block group(ACB+IPACK) |
Primary outcome
opioid consumption
Time frame: 24 hours after surgery
In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 4 mg 1 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Verbal analog Pain Scores on rest and movement
Time frame: 24 hours after surgery
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
1 secondary outcome
incidences of adverse effects (like nausea and vomiting)
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 38235397Shoni M, Samineni AV, Salavati S, Mikkilineni N, Wang A, Abdeen A, Freccero D. Combined Single-Shot Infiltration Between the Popliteal Artery and Capsule of the Knee and Adductor Canal Block With Bupivacaine, Dexmedetomidine, and Dexamethasone for Total Knee Arthroplasty: A Propensity-Matched Analysis. Arthroplast Today. 2023 Dec 28;25:101292. doi: 10.1016/j.artd.2023.101292. eCollection 2024 Feb.
- Results publication: PubMed 25154949Mariano ER, Kim TE, Wagner MJ, Funck N, Harrison TK, Walters T, Giori N, Woolson S, Ganaway T, Howard SK. A randomized comparison of proximal and distal ultrasound-guided adductor canal catheter insertion sites for knee arthroplasty. J Ultrasound Med. 2014 Sep;33(9):1653-62. doi: 10.7863/ultra.33.9.1653.
- Combined Single-Shot Infiltration Between the Popliteal Artery and Capsule of the Knee and Adductor Canal Block With Bupivacaine, Dexmedetomidine, and Dexamethasone for Total Knee Arthroplasty: A Propensity-Matched AnalysisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Sibel Pehlivan study director
Erciyes Üniversitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty, Total, run by TC Erciyes University at 2 sites 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibel Pehlivan, DR (0905052532919, Sibelpehlivan@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption (time frame: 24 hours 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 NCT07526831, which also lists 2 linked publications.
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 May 2026.