- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05956275
USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia
July 13, 2023 updated by: asım erçelik, Siirt Training and Research Hospital
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bolu, Turkey, 14030
- Bolu Abant Izzet Baysal University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: adductor canal block and infiltration popliteal artery capsule knee block
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.
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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.
No block was applied to the patients in control
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Sham Comparator: Control
No block performed
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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.
No block was applied to the patients in control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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tramadol consumption
Time Frame: 24 hours
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tramadol consumption amounts were 0-1 hours, 1-12 hours, 12-24 hours
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24 hours
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using morphine as rescue analgesia
Time Frame: 24 hours
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rescue analgesia was evaluated for 0-1 hour, 1-12 hours, and 12-24, the number of patients who used morphine
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24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Kutay Engin Özturan, Professor, Bolu Abant Izzet Baysal University
- Study Chair: Cengiz Işık, Professor, Bolu Abant Izzet Baysal University
- Study Chair: Asım İlker İtal, MD, Bolu Abant Izzet Baysal University
- Study Chair: Mustafa Türkoğlu, MD, Bolu Abant Izzet Baysal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thobhani 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.
- Shah 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.
- Jaeger P, Koscielniak-Nielsen ZJ, Hilsted KL, Fabritius ML, Dahl JB. Adductor Canal Block With 10 mL Versus 30 mL Local Anesthetics and Quadriceps Strength: A Paired, Blinded, Randomized Study in Healthy Volunteers. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):553-8. doi: 10.1097/AAP.0000000000000298.
- Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
- Chan 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.
- 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.
- Ryu 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.
- Singelyn 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.
- Lamplot 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.
- Chia 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. Erratum In: Singapore Med J. 2002 Dec;43(12):604.
- Gurkan 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.
- Li 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.
- Li 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.
- Zhao 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.
- Li 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.
- Canbek 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.
- Cullom 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.
- Ochroch J, Qi V, Badiola I, Grosh T, Cai L, Graff V, Nelson C, Israelite C, Elkassabany NM. Analgesic efficacy of adding the IPACK block to a multimodal analgesia protocol for primary total knee arthroplasty. Reg Anesth Pain Med. 2020 Oct;45(10):799-804. doi: 10.1136/rapm-2020-101558. Epub 2020 Aug 31.
- Tao Y, Zheng SQ, Xu T, Wang G, Wang Y, Wu AS, Yue Y. Median effective volume of ropivacaine 0.5% for ultrasound-guided adductor canal block. J Int Med Res. 2018 Oct;46(10):4207-4213. doi: 10.1177/0300060518791685. Epub 2018 Aug 20.
- Kampitak W, Tanavalee A, Ngarmukos S, Tantavisut S. Motor-sparing effect of iPACK (interspace between the popliteal artery and capsule of the posterior knee) block versus tibial nerve block after total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2020 Apr;45(4):267-276. doi: 10.1136/rapm-2019-100895. Epub 2020 Feb 4.
- Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.
- Xu Z, Zhang H, Luo J, Zhou A, Zhang J. Preemptive analgesia by using celecoxib combined with tramadol/APAP alleviates post-operative pain of patients undergoing total knee arthroplasty. Phys Sportsmed. 2017 Sep;45(3):316-322. doi: 10.1080/00913847.2017.1325312. Epub 2017 May 17.
- DeMik DE, Carender CN, Shamrock AG, Callaghan JJ, Bedard NA. Opioid Use After Total Knee Arthroplasty: Does Tramadol Have Lower Risk Than Traditional Opioids? J Arthroplasty. 2020 Jun;35(6):1558-1562. doi: 10.1016/j.arth.2020.01.055. Epub 2020 Jan 28.
- Et T, Korkusuz M, Basaran B, Yarimoglu R, Toprak H, Bilge A, Kumru N, Dedeli I. Comparison of iPACK and periarticular block with adductor block alone after total knee arthroplasty: a randomized clinical trial. J Anesth. 2022 Apr;36(2):276-286. doi: 10.1007/s00540-022-03047-6. Epub 2022 Feb 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 8, 2020
Primary Completion (Actual)
October 1, 2021
Study Completion (Actual)
October 2, 2021
Study Registration Dates
First Submitted
July 4, 2023
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 21, 2023
Study Record Updates
Last Update Posted (Actual)
July 21, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-TF-AR-AE-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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