AnalgesiaNCT05963139
Comparison of Local Anesthetic Dose in Ipack Block Performed in Knee Arthroplasty Operations
A study testing Bupivacaine and Morphine Sulfate in people with Analgesia and Pain, Postoperative, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The investigators research was designed as a single-center, prospective, randomized study. The patients undergoing knee artrhroplasty surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Pain, Postoperative, Anesthesia
- What is being tested?
- Bupivacaine and Morphine Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 10 Feb 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for knee arthroplasty surgery under regional anesthesia
- ASA(American Society of Anesthesiology) 1-3
- Receiving consent that accept regional analgesia
Who cannot join
- Refusal of regional anesthesia
- Infection on the local anesthetic application area
- Infection in the central nervous system
- Coagulopathy
- BMI > 40
- Known allergy against local anesthetics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Medical Faculty
Istanbul
About this study
Official title: Comparison of Local Anesthetic Dose in IPACK (Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee) Block Performed for Postoperative Analgesia in Knee Artroplasty Operations
The investigators research was designed as a single-center, prospective, randomized study. The patients undergoing knee artrhroplasty surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.
Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included.
Read more
IPACK and adductor block will be done for postoperative analgesia. After then, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done.
In the investigators clinic, the use of IPACK block, adductor block and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is routinely performed. In this study, four randomized groups will be formed together with the control group.
IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25% bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is performed.
Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups. As in routine practice, when NRS > 4 after each interrogation, morphine 2 mg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS < 4.
Read the detailed description
The investigators research was designed as a single-center, prospective, randomized study.
The patients undergoing knee arthroplasty in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.
Patients will be evaluated preoperative before surgery, a detailed history will be taken and physical examination will be carried out. Medical and surgical resume information will be obtained. Patients' NRS scores will be recorded before the operation. Patients will be taken to the operating room after premedication.
ECG, pulse oximeter, blood pressure monitoring will be performed in the operating room. Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included.
IPACK and adductor block will be done for postoperative analgesia. After then, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation.ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done.
In the investigators clinic, the use of IPACK block, adductor block and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is routinely performed. In this study, four randomized groups will be formed together with the control group.Computer-generated random numbers will be used for simple randomization of patients.
IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25% bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is performed.
Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups. As in routine practice, when NRS > 4 after each interrogation, morphine 2 mg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS < 4.
Patients are followed up in the service for 48 hours postoperatively in routine practice.
In the postoperative period, patients will be evaluated in terms of additional nausea and vomiting,amount of morphine consumed and additional analgesic need postoperative period up to 48 hours.First mobilization time, hospitalization time will be evaluated.Womac osteoarthritis index and joint range of motion will be evaluated at preoperative period and at the discharge day from the hospital.The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity will be evaluated preoperative period, at postoperative 24th hour and at the discharge day from the hospital.
Postop patient satisfaction and surgical satisfaction with Likert scale will also be evaluated at postoperative period.
During the procedure, complications such as failed block, nerve damage, vascular injury, intravenous injection of local anesthetic, local anesthetic toxicity and allergic reactions will be recorded.
Before the study, it was determined that at least 112 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic data and morphine consumption data of the patients, the data will be transferred to the statistical program called SPSS and statistical analysis will be made.The investigators study does not contain any modifications other than the investigators daily routine practices.
- Conditions
- Analgesia, Pain, Postoperative, Anesthesia
- Being tested
- Bupivacaine, Morphine Sulfate
- Keywords
- IPACK block, Postoperative Pain, Postoperative Patient Controlled Analgesia, Knee Artroplasty, Regional Anesthesia, Numeric rating scale
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
US guided IPACK block will be performed with 10/15/20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0,25 bupivacaine.
Morphine SulfateDrug
Also called morphine
In this group,adductor block will be performed with 15 ml %0,25 bupivacaine using a 22 gauge 10 mm block needle and patients will be postoperatively administered patient controlled analgesia with morphine.
| Study group | Role | What they receive |
|---|---|---|
| Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block | Active comparator | In this group,US guided IPACK block will be performed with 10 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle. Receives: Drug: Bupivacaine; Drug: Morphine Sulfate |
| Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block | Active comparator | In this group,US guided IPACK block will be performed with 15 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle. Receives: Drug: Bupivacaine; Drug: Morphine Sulfate |
| Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block | Active comparator | In this group,US guided IPACK block will be performed with 20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle. Receives: Drug: Bupivacaine; Drug: Morphine Sulfate |
| Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia | Active comparator | In this group adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle and postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method. Receives: Drug: Bupivacaine; Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale(0-10)pain scores for patients.
NRS(Numeric Rating Scale),0:no pain,10:the worst pain.
Measured: postoperative period up to 48 hours
Opioid (mg) consumption
Opioid (mg) consumption
Measured: postoperative period up to 48th hours
Secondary outcomes (8)
Incidence of side effects
Incidence of nausea and vomiting
Measured: postoperative period up to 48th hours
Time until postoperative first mobilization
First mobilization time
Measured: Up to 48 hours
Length of hospital stay
Hospitalization
Measured: Through study completion, an average of 1 week.
Womac osteoarthritis index
Womac osteoarthritis index
Measured: Discharge 1 day from the hospital
The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity
The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).
Measured: Discharge 1 day from the hospital
Joint range of motion
Joint range of motion
Measured: Postoperative period up to 48th hours, discharge 1 day
Patient satisfaction
Satisfaction score;0-very unsatisfied,5-very satisfied.
Measured: Postoperative period up to 48th hours
Surgeon satisfaction
Satisfaction score;0-very unsatisfied,5-very satisfied.
Measured: Postoperative period up to 48th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Canbolat, Istanbul University
- Investigators
- GÜLBERK KILIÇ, MD, Principal investigator, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963139
- Sponsor's protocol ID
- 2022-1481345
- Status last verified
- Feb 2024
- First submitted
- 19 Jul 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng FY, Liu YB, Huang H, Xu S, Ma XJ, Liu YZ, Chu HC. The impact of IPACK combined with adductor canal block under ultrasound guidance on early motor function after total knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):110-114. doi: 10.1016/j.bjane.2021.04.012. Epub 2021 Apr 26.
PubMed 33915199Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.
PubMed 30234517Patterson ME, Vitter J, Bland K, Nossaman BD, Thomas LC, Chimento GF. The Effect of the IPACK Block on Pain After Primary TKA: A Double-Blinded, Prospective, Randomized Trial. J Arthroplasty. 2020 Jun;35(6S):S173-S177. doi: 10.1016/j.arth.2020.01.014. Epub 2020 Jan 15.
PubMed 32005622D'Souza RS, Langford BJ, Olsen DA, Johnson RL. Ultrasound-Guided Local Anesthetic Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee (IPACK) Block for Primary Total Knee Arthroplasty: A Systematic Review of Randomized Controlled Trials. Local Reg Anesth. 2021 May 12;14:85-98. doi: 10.2147/LRA.S303827. eCollection 2021.
PubMed 34012290
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Local Anesthetic Dose in IPACK (Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee) Block Performed for Postoperative Analgesia in Knee Artroplasty Operations
- ClinicalTrials.gov ID
- NCT05963139
- Acronym / sponsor ID
- 2022-1481345
- Conditions
- Analgesia, Pain, Postoperative, Anesthesia
- Keywords
- IPACK block, Postoperative Pain, Postoperative Patient Controlled Analgesia, Knee Artroplasty, Regional Anesthesia, Numeric rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 27 Jul 2023 (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.
The investigators research was designed as a single-center, prospective, randomized study. The patients undergoing knee artrhroplasty surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.
Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included.
IPACK and adductor block will be done for postoperative analgesia. After then, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done.
In the investigators clinic, the use of IPACK block, adductor block and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is routinely performed. In this study, four randomized groups will be formed together with the control group.
IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25% bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is performed.
Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups. As in routine practice, when NRS > 4 after each interrogation, morphine 2 mg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS < 4.
Detailed description
The investigators research was designed as a single-center, prospective, randomized study.
The patients undergoing knee arthroplasty in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.
Patients will be evaluated preoperative before surgery, a detailed history will be taken and physical examination will be carried out. Medical and surgical resume information will be obtained. Patients' NRS scores will be recorded before the operation. Patients will be taken to the operating room after premedication.
ECG, pulse oximeter, blood pressure monitoring will be performed in the operating room. Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included.
IPACK and adductor block will be done for postoperative analgesia. After then, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation.ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done.
In the investigators clinic, the use of IPACK block, adductor block and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is routinely performed. In this study, four randomized groups will be formed together with the control group.Computer-generated random numbers will be used for simple randomization of patients.
IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25% bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is performed.
Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups. As in routine practice, when NRS > 4 after each interrogation, morphine 2 mg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS < 4.
Patients are followed up in the service for 48 hours postoperatively in routine practice.
In the postoperative period, patients will be evaluated in terms of additional nausea and vomiting,amount of morphine consumed and additional analgesic need postoperative period up to 48 hours.First mobilization time, hospitalization time will be evaluated.Womac osteoarthritis index and joint range of motion will be evaluated at preoperative period and at the discharge day from the hospital.The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity will be evaluated preoperative period, at postoperative 24th hour and at the discharge day from the hospital.
Postop patient satisfaction and surgical satisfaction with Likert scale will also be evaluated at postoperative period.
During the procedure, complications such as failed block, nerve damage, vascular injury, intravenous injection of local anesthetic, local anesthetic toxicity and allergic reactions will be recorded.
Before the study, it was determined that at least 112 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic data and morphine consumption data of the patients, the data will be transferred to the statistical program called SPSS and statistical analysis will be made.The investigators study does not contain any modifications other than the investigators daily routine practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block | Active comparator | Drug: Bupivacaine, Drug: Morphine SulfateIn this group,US guided IPACK block will be performed with 10 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle. |
| Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block | Active comparator | Drug: Bupivacaine, Drug: Morphine SulfateIn this group,US guided IPACK block will be performed with 15 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle. |
| Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block | Active comparator | Drug: Bupivacaine, Drug: Morphine SulfateIn this group,US guided IPACK block will be performed with 20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle. |
| Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia | Active comparator | Drug: Bupivacaine, Drug: Morphine SulfateIn this group adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle and postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for knee arthroplasty surgery under regional anesthesia
- ASA(American Society of Anesthesiology) 1-3
- Receiving consent that accept regional analgesia
Key exclusion criteria (6 listed)
- Refusal of regional anesthesia
- Infection on the local anesthetic application area
- Infection in the central nervous system
- Coagulopathy
- 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 |
|---|---|---|
| BupivacaineAlso: MarcaineUS guided IPACK block will be performed with 10/15/20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0,25 bupivacaine. | Drug | Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block, Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block, Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block, Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia |
| Morphine SulfateAlso: morphineIn this group,adductor block will be performed with 15 ml %0,25 bupivacaine using a 22 gauge 10 mm block needle and patients will be postoperatively administered patient controlled analgesia with morphine. | Drug | Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block, Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block, Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block, Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia |
Primary outcome
Numeric Rating Scale(0-10)pain scores for patients.
Time frame: postoperative period up to 48 hours
NRS(Numeric Rating Scale),0:no pain,10:the worst pain.
Opioid (mg) consumption
Time frame: postoperative period up to 48th hours
Opioid (mg) consumption
8 secondary outcomes
Incidence of side effects
Time frame: postoperative period up to 48th hours
Time until postoperative first mobilization
Time frame: Up to 48 hours
Length of hospital stay
Time frame: Through study completion, an average of 1 week.
Womac osteoarthritis index
Time frame: Discharge 1 day from the hospital
The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity
Time frame: Discharge 1 day from the hospital
Joint range of motion
Time frame: Postoperative period up to 48th hours, discharge 1 day
Patient satisfaction
Time frame: Postoperative period up to 48th hours
Surgeon satisfaction
Time frame: Postoperative period up to 48th 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 13 Feb 2024.
- Background: PubMed 33915199Zheng FY, Liu YB, Huang H, Xu S, Ma XJ, Liu YZ, Chu HC. The impact of IPACK combined with adductor canal block under ultrasound guidance on early motor function after total knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):110-114. doi: 10.1016/j.bjane.2021.04.012. Epub 2021 Apr 26.
- Background: PubMed 30234517Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.
- Background: PubMed 32005622Patterson ME, Vitter J, Bland K, Nossaman BD, Thomas LC, Chimento GF. The Effect of the IPACK Block on Pain After Primary TKA: A Double-Blinded, Prospective, Randomized Trial. J Arthroplasty. 2020 Jun;35(6S):S173-S177. doi: 10.1016/j.arth.2020.01.014. Epub 2020 Jan 15.
- Background: PubMed 34012290D'Souza RS, Langford BJ, Olsen DA, Johnson RL. Ultrasound-Guided Local Anesthetic Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee (IPACK) Block for Primary Total Knee Arthroplasty: A Systematic Review of Randomized Controlled Trials. Local Reg Anesth. 2021 May 12;14:85-98. doi: 10.2147/LRA.S303827. eCollection 2021.
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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.
GÜLBERK KILIÇ, MD principal investigator
Istanbul Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Morphine Sulfate in people with Analgesia and Pain, Postoperative, run by Istanbul 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 6 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 13 Feb 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?
Numeric Rating Scale(0-10)pain scores for patients. (time frame: postoperative period up to 48 hours). 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 NCT05963139, which also lists 4 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 13 Feb 2024.