IPACK Block Multimodal AnalgesiaNCT04213287
Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty
A study testing Dexketoprofen Trometamol, spinal anesthesia and IPACK in people with IPACK Block Multimodal Analgesia and Postoperative NRS Scores, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ Infiltration of the interspace between the popliteal artery and the capsule of the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- IPACK Block Multimodal Analgesia, Postoperative NRS Scores
- What is being tested?
- Dexketoprofen Trometamol, spinal anesthesia and IPACK
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2019to 15 Mar 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
- Age 18 to 80 years
- Planned use of regional anesthesia
- Ability to follow study protocol
- Patients of participating surgeons
Who cannot join
- Hepatic or renal insufficiency
- Younger than 18 years old and older than 80
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI > 40
- Diabetes
Show all 9Show fewer
- ASA of IV
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Diskapi Yildirim Beyazit Training Research Hospital
Ankara, Altındag, 06450
ilkay baran, md, 5323852642, ilkayb@hotmail.com
About this study
Official title: Evaluation of Multimodal Analgesia Methods in Patients Who Underwent IPACK Block in Total Knee Arthroplasty
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) - in patients undergoing total knee arthroplasty. dexketoprofen and paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
Read the detailed description
Postoperative pain after total knee arthroplasty is serious and difficult to management. Multimodal analgesia recommended for the pain management. For these reasons, we planned a study involving two multimodal analgesia regimens. Patients who will undergo total knee arthroplasty will receive preemptive oral analgesic (dexketofrofen) 1 hour before the operation. Surgery will be initiated after spinal anesthesia is applied to the patients. Two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ IPACK- will be applied at the end of the surgery. dexketoprofenand paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
- Being tested
- Dexketoprofen Trometamol, spinal anesthesia, IPACK, PAI, Adductor canal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexketoprofen TrometamolDrug
Drug: Dexketoprofen Trometamol oral tablet
spinal anesthesiaOther
Drug: heavy bupivacaine 2,5 ml 0,5%
IPACKOther
Drug: bupivacaine 20 ml 0,025%
PAIOther
Drug: bupivacaine 30 ml 0,025%
Adductor canal blockOther
Drug: bupivacaine 20 ml 0,025%
| Study group | Role | What they receive |
|---|---|---|
| Peri-Articular Injections and IPACK | Experimental | Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
PAI: 30 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine Receives: Drug: Dexketoprofen Trometamol; Other: spinal anesthesia; Other: IPACK; Other: PAI |
| Adductor Canal Block, and IPACK | Active comparator | Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
ADD: 20 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine Receives: Drug: Dexketoprofen Trometamol; Other: spinal anesthesia; Other: IPACK; Other: Adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS Pain Scores
NRS Pain scores with ambulation 24 hours post block administration.All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Measured: 24 hours post block administration
Secondary outcomes (2)
NRS at Rest and with movement
NRS at rest and with movement at different intervals. All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Measured: 24 hours on Post-Operative Day 1
Patient Satisfaction with Pain Control using the likert scale
Satisfaction with Pain control at different intervals. 1-5 (according to patient satisfaction)
Measured: Post-Operative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start23 Dec 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPACK Block Multimodal AnalgesiaStudies 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
- Power analysis will be done after a pilot study. Number of patient may vary.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilkay baran akkuş, Ankara Diskapi Training and Research Hospital
- Investigators
- Ilkay MD Baran Akkuş, MD, Principal investigator, Diskapi Yildirim Beyazit Training Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213287
- Sponsor's protocol ID
- 70/13
- Status last verified
- Dec 2019
- First submitted
- 23 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multimodal Analgesia Methods in Patients Who Underwent IPACK Block in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04213287
- Acronym / sponsor ID
- 70/13
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 30 Dec 2019 (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.
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) - in patients undergoing total knee arthroplasty. dexketoprofen and paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
Detailed description
Postoperative pain after total knee arthroplasty is serious and difficult to management. Multimodal analgesia recommended for the pain management. For these reasons, we planned a study involving two multimodal analgesia regimens. Patients who will undergo total knee arthroplasty will receive preemptive oral analgesic (dexketofrofen) 1 hour before the operation. Surgery will be initiated after spinal anesthesia is applied to the patients. Two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ IPACK- will be applied at the end of the surgery. dexketoprofenand paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Power analysis will be done after a pilot study. Number of patient may vary.
| Arm | Type | Receives |
|---|---|---|
| Peri-Articular Injections and IPACK | Experimental | Drug: Dexketoprofen Trometamol, Other: spinal anesthesia, Other: IPACK, Other: PAISpinal anesthetic with 2,5 ml 0,5% heavy bupivacaine At the end of surgery; PAI: 30 ml 0,025% bupivacaine and IPACK: 20 ml 0,025% bupivacaine |
| Adductor Canal Block, and IPACK | Active comparator | Drug: Dexketoprofen Trometamol, Other: spinal anesthesia, Other: IPACK, Other: Adductor canal blockSpinal anesthetic with 2,5 ml 0,5% heavy bupivacaine At the end of surgery; ADD: 20 ml 0,025% bupivacaine and IPACK: 20 ml 0,025% bupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
- Age 18 to 80 years
- Planned use of regional anesthesia
- Ability to follow study protocol
- Patients of participating surgeons
Key exclusion criteria (9 listed)
- Hepatic or renal insufficiency
- Younger than 18 years old and older than 80
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI > 40
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 |
|---|---|---|
| Dexketoprofen TrometamolDrug: Dexketoprofen Trometamol oral tablet | Drug | Adductor Canal Block, and IPACK, Peri-Articular Injections and IPACK |
| spinal anesthesiaDrug: heavy bupivacaine 2,5 ml 0,5% | Other | Adductor Canal Block, and IPACK, Peri-Articular Injections and IPACK |
| IPACKDrug: bupivacaine 20 ml 0,025% | Other | Adductor Canal Block, and IPACK, Peri-Articular Injections and IPACK |
| PAIDrug: bupivacaine 30 ml 0,025% | Other | Peri-Articular Injections and IPACK |
| Adductor canal blockDrug: bupivacaine 20 ml 0,025% | Other | Adductor Canal Block, and IPACK |
Primary outcome
NRS Pain Scores
Time frame: 24 hours post block administration
NRS Pain scores with ambulation 24 hours post block administration.All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
2 secondary outcomes
NRS at Rest and with movement
Time frame: 24 hours on Post-Operative Day 1
Patient Satisfaction with Pain Control using the likert scale
Time frame: Post-Operative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
Related trials for IPACK Block Multimodal Analgesia
Not yet recruiting
A Randomized Comparison of the Efficacy of the IPACK Block Versus the Popliteal Plexus Block for Posterior Knee Analgesia, in Patients Undergoing a Total Knee Arthroplasty and Receiving a Continuous Distal Femoral Triangle Block
Osteoarthritis, Knee, Postoperative Pain
Not yet recruiting
Postoperative Analgesic Efficacy Between Adductor Canal Block + IPACK Block and Adductor Canal Block + Genicular Nerve Block in Total Knee Arthroplasty
Total Knee Arthroplasty, Adductor Canal Block
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.
Ilkay MD Baran Akkuş, MD principal investigator
Diskapi Yildirim Beyazit Training Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexketoprofen Trometamol, spinal anesthesia and IPACK in people with IPACK Block Multimodal Analgesia and Postoperative NRS Scores, run by Ankara Diskapi Training and Research Hospital 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilkay MD Baran akkus, MD (0905323852642 ext. 0903125902000, ilkayb@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS Pain Scores (time frame: 24 hours post block administration). 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 30 Dec 2019.