Postoperative PainPhase 4NCT05956275
USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia
A Phase 4 study testing Tramadol and Morfin in people with Postoperative Pain, run by Siirt Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose was to evaluate the effect of USG-guided adductor canal block and infiltration popliteal artery capsule knee block combination on postoperative analgesia before total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Tramadol and Morfin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2020to 2 Oct 2021
- Phase
- Phase 4
- 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
- aged between 18-75 years
- who were scheduled for elective total knee arthroplasty in Bolu Abant Izzet Baysal University Training and Research Hospital Orthopaedics and Traumatology Clinics
Who cannot join
- Patients with hypersensitivity to the drugs to be used in the study or the substances in their composition
- pregnant women
- severe cardiac, pulmonary, hepatic, and renal disease
- a history of chronic opioid use and chronic pain syndrome
- patients who were not suitable for regional anesthesia (bleeding diathesis, infection in the procedure area), and those who could not apply patient controlled anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University
Bolu, 14030
About this study
Official title: Comparison Between USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia in Total Knee Prosthesis Under General Anesthesia: Randomized Clinical Trial
The purpose was to evaluate the effect of USG-guided adductor canal block and infiltration popliteal artery capsule knee block combination on postoperative analgesia before total knee arthroplasty.
Read the detailed description
In the present study, the purpose was to evaluate the effect of Ultrasound(USG)-guided adductor canal block(ACB) and infiltration popliteal artery capsule knee block(IPACK) combination on postoperative analgesia before total knee arthroplasty(TKA). A total of 40 patients,who were aged 18-75 with the American Society of Anesthesiologists score(ASA) I-III physical status,and who were scheduled for TKA under general anesthesia,were included in the present study.ACB and IPACK were performed in group A(ACB+IPACK) accompanied by USG, Bupivacaine and 10 mL of 0.9% sodium chloride were applied in each block application.No block was applied to the patients in group B.Patient-controlled analgesia was administered to both groups 30 minutes before the end of the surgery.Tramadol HCL was infused at a concentration of 4mg/ml.A bolus of 20 mg of tramadol hydrochloride was given with a lock-in interval of 30 minutes.Postoperative systolic arterial pressure(SAP),diastolic arterial pressure(DAP),mean arterial pressure(MAP),heart rate(HR),visual analog scale(VAS),analgesic consumption,nausea,vomiting, and patient satisfaction scores were recorded.
- Conditions
- Postoperative Pain
- Being tested
- Tramadol, Morfin
- Keywords
- Postoperative pain, Adductor canal block, Infiltration popliteal artery capsule knee block, Tramadol, Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
ACB and IPACK were performed in USG-guided adductor canal block and infiltration popliteal artery capsule knee block accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application.
MorfinDrug
No block was applied to the patients in control
| Study group | Role | What they receive |
|---|---|---|
| adductor canal block and infiltration popliteal artery capsule knee block | Active comparator | Adductor canal block and infiltration popliteal artery capsule knee block were performed accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application. Receives: Drug: Tramadol; Drug: Morfin |
| Control | Sham comparator | No block performed Receives: Drug: Tramadol; Drug: Morfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
tramadol consumption
tramadol consumption amounts were 0-1 hours, 1-12 hours, 12-24 hours
Measured: 24 hours
using morphine as rescue analgesia
rescue analgesia was evaluated for 0-1 hour, 1-12 hours, and 12-24, the number of patients who used morphine
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start8 Dec 2020
- Primary completion1 Oct 2021
- Study completion2 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siirt Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Abant Izzet Baysal University
- Responsible party
- Principal investigator, asım erçelik, Siirt Training and Research Hospital
- Investigators
- Kutay Engin Özturan, Professor, Study chair, Abant Izzet Baysal UniversityCengiz Işık, Professor, Study chair, Abant Izzet Baysal UniversityAsım İlker İtal, MD, Study chair, Abant Izzet Baysal UniversityMustafa Türkoğlu, MD, Study chair, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956275
- Sponsor's protocol ID
- AIBU-TF-AR-AE-001
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a thesis that I did and presented two years ago. The raw data has not been backed up after going through statistical analysis.
Publications
Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.
PubMed 9661553Ryu J, Saito S, Yamamoto K, Sano S. Factors influencing the postoperative range of motion in total knee arthroplasty. Bull Hosp Jt Dis. 1993 Summer;53(3):35-40.
PubMed 8012266Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
PubMed 9661552Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.
PubMed 23850410Chia N, Low TC, Poon KH. Peripheral nerve blocks for lower limb surgery--a choice anaesthetic technique for patients with a recent myocardial infarction? Singapore Med J. 2002 Nov;43(11):583-6.
PubMed 12680529Gurkan Y, Acar S, Solak M, Toker K. Comparison of nerve stimulation vs. ultrasound-guided lateral sagittal infraclavicular block. Acta Anaesthesiol Scand. 2008 Jul;52(6):851-5. doi: 10.1111/j.1399-6576.2008.01655.x. Epub 2008 May 12.
PubMed 18477077Li D, Yang Z, Xie X, Zhao J, Kang P. Adductor canal block provides better performance after total knee arthroplasty compared with femoral nerve block: a systematic review and meta-analysis. Int Orthop. 2016 May;40(5):925-33. doi: 10.1007/s00264-015-2998-x. Epub 2015 Oct 10.
PubMed 26452678Shah NA, Jain NP. Is continuous adductor canal block better than continuous femoral nerve block after total knee arthroplasty? Effect on ambulation ability, early functional recovery and pain control: a randomized controlled trial. J Arthroplasty. 2014 Nov;29(11):2224-9. doi: 10.1016/j.arth.2014.06.010. Epub 2014 Jun 19.
PubMed 25041873Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.
PubMed 29026354Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.
PubMed 31663286Zhao J, Davis SP. An integrative review of multimodal pain management on patient recovery after total hip and knee arthroplasty. Int J Nurs Stud. 2019 Oct;98:94-106. doi: 10.1016/j.ijnurstu.2019.06.010. Epub 2019 Jun 28.
PubMed 31352132Li D, Alqwbani M, Wang Q, Liao R, Yang J, Kang P. Efficacy of Adductor Canal Block Combined With Additional Analgesic Methods for Postoperative Analgesia in Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study. J Arthroplasty. 2020 Dec;35(12):3554-3562. doi: 10.1016/j.arth.2020.06.060. Epub 2020 Jun 24.
PubMed 32680754Canbek U, Akgun U, Aydogan NH, Kilinc CY, Uysal AI. Continuous adductor canal block following total knee arthroplasty provides a better analgesia compared to single shot: A prospective randomized controlled trial. Acta Orthop Traumatol Turc. 2019 Sep;53(5):334-339. doi: 10.1016/j.aott.2019.04.001. Epub 2019 May 2.
PubMed 31056404Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.
PubMed 28283810Chan E, Howle R, Onwochei D, Desai N. Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. Reg Anesth Pain Med. 2021 Sep;46(9):784-805. doi: 10.1136/rapm-2021-102681. Epub 2021 May 14.
PubMed 33990439
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia in Total Knee Prosthesis Under General Anesthesia: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05956275
- Acronym / sponsor ID
- AIBU-TF-AR-AE-001
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Adductor canal block, Infiltration popliteal artery capsule knee block, Tramadol, Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Siirt Training and Research HospitalOther government
- Collaborators
- Abant Izzet Baysal University
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 21 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 purpose was to evaluate the effect of USG-guided adductor canal block and infiltration popliteal artery capsule knee block combination on postoperative analgesia before total knee arthroplasty.
Detailed description
In the present study, the purpose was to evaluate the effect of Ultrasound(USG)-guided adductor canal block(ACB) and infiltration popliteal artery capsule knee block(IPACK) combination on postoperative analgesia before total knee arthroplasty(TKA). A total of 40 patients,who were aged 18-75 with the American Society of Anesthesiologists score(ASA) I-III physical status,and who were scheduled for TKA under general anesthesia,were included in the present study.ACB and IPACK were performed in group A(ACB+IPACK) accompanied by USG, Bupivacaine and 10 mL of 0.9% sodium chloride were applied in each block application.No block was applied to the patients in group B.Patient-controlled analgesia was administered to both groups 30 minutes before the end of the surgery.Tramadol HCL was infused at a concentration of 4mg/ml.A bolus of 20 mg of tramadol hydrochloride was given with a lock-in interval of 30 minutes.Postoperative systolic arterial pressure(SAP),diastolic arterial pressure(DAP),mean arterial pressure(MAP),heart rate(HR),visual analog scale(VAS),analgesic consumption,nausea,vomiting, and patient satisfaction scores were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adductor canal block and infiltration popliteal artery capsule knee block | Active comparator | Drug: Tramadol, Drug: MorfinAdductor canal block and infiltration popliteal artery capsule knee block were performed accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application. |
| Control | Sham comparator | Drug: Tramadol, Drug: MorfinNo block performed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 18-75 years
- who were scheduled for elective total knee arthroplasty in Bolu Abant Izzet Baysal University Training and Research Hospital Orthopaedics and Traumatology Clinics
Key exclusion criteria (5 listed)
- Patients with hypersensitivity to the drugs to be used in the study or the substances in their composition
- pregnant women
- severe cardiac, pulmonary, hepatic, and renal disease
- a history of chronic opioid use and chronic pain syndrome
- patients who were not suitable for regional anesthesia (bleeding diathesis, infection in the procedure area), and those who could not apply patient controlled anesthesia
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 |
|---|---|---|
| TramadolACB and IPACK were performed in USG-guided adductor canal block and infiltration popliteal artery capsule knee block accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application. | Drug | Control, adductor canal block and infiltration popliteal artery capsule knee block |
| MorfinNo block was applied to the patients in control | Drug | Control, adductor canal block and infiltration popliteal artery capsule knee block |
Primary outcome
tramadol consumption
Time frame: 24 hours
tramadol consumption amounts were 0-1 hours, 1-12 hours, 12-24 hours
using morphine as rescue analgesia
Time frame: 24 hours
rescue analgesia was evaluated for 0-1 hour, 1-12 hours, and 12-24, the number of patients who used morphine
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 21 Jul 2023.
- Results publication: PubMed 9661553Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.
- Results publication: PubMed 8012266Ryu J, Saito S, Yamamoto K, Sano S. Factors influencing the postoperative range of motion in total knee arthroplasty. Bull Hosp Jt Dis. 1993 Summer;53(3):35-40.
- Results publication: PubMed 9661552Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
- Results publication: PubMed 23850410Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.
- Results publication: PubMed 12680529Chia N, Low TC, Poon KH. Peripheral nerve blocks for lower limb surgery--a choice anaesthetic technique for patients with a recent myocardial infarction? Singapore Med J. 2002 Nov;43(11):583-6.
- Results publication: PubMed 18477077Gurkan Y, Acar S, Solak M, Toker K. Comparison of nerve stimulation vs. ultrasound-guided lateral sagittal infraclavicular block. Acta Anaesthesiol Scand. 2008 Jul;52(6):851-5. doi: 10.1111/j.1399-6576.2008.01655.x. Epub 2008 May 12.
- Results publication: PubMed 26452678Li D, Yang Z, Xie X, Zhao J, Kang P. Adductor canal block provides better performance after total knee arthroplasty compared with femoral nerve block: a systematic review and meta-analysis. Int Orthop. 2016 May;40(5):925-33. doi: 10.1007/s00264-015-2998-x. Epub 2015 Oct 10.
- Results publication: PubMed 25041873Shah NA, Jain NP. Is continuous adductor canal block better than continuous femoral nerve block after total knee arthroplasty? Effect on ambulation ability, early functional recovery and pain control: a randomized controlled trial. J Arthroplasty. 2014 Nov;29(11):2224-9. doi: 10.1016/j.arth.2014.06.010. Epub 2014 Jun 19.
- Results publication: PubMed 29026354Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.
- Results publication: PubMed 31663286Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.
- Results publication: PubMed 31352132Zhao J, Davis SP. An integrative review of multimodal pain management on patient recovery after total hip and knee arthroplasty. Int J Nurs Stud. 2019 Oct;98:94-106. doi: 10.1016/j.ijnurstu.2019.06.010. Epub 2019 Jun 28.
- Results publication: PubMed 32680754Li D, Alqwbani M, Wang Q, Liao R, Yang J, Kang P. Efficacy of Adductor Canal Block Combined With Additional Analgesic Methods for Postoperative Analgesia in Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study. J Arthroplasty. 2020 Dec;35(12):3554-3562. doi: 10.1016/j.arth.2020.06.060. Epub 2020 Jun 24.
- Individual participant dataSharing planned: No. This study is a thesis that I did and presented two years ago. The raw data has not been backed up after going through statistical analysis.
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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.
Kutay Engin Özturan, Professor study chair
Abant Izzet Baysal University
Cengiz Işık, Professor study chair
Abant Izzet Baysal University
Asım İlker İtal, MD study chair
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol and Morfin in people with Postoperative Pain, run by Siirt 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 2 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 21 Jul 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
tramadol consumption (time frame: 24 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 NCT05956275, which also lists 24 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 21 Jul 2023.