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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05956275
Other study ID # AIBU-TF-AR-AE-001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 8, 2020
Est. completion date October 2, 2021

Study information

Verified date July 2023
Source Siirt Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 2, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Tramadol
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.
Morfin
No block was applied to the patients in control

Locations

Country Name City State
Turkey Bolu Abant Izzet Baysal University Bolu

Sponsors (2)

Lead Sponsor Collaborator
Siirt Training and Research Hospital Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (24)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 10.100 — View Citation

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. — View Citation

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) — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 No — View Citation

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 unilatera — View Citation

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. — View Citation

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 — View Citation

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: 10.1080/00913847.2017.13 — View Citation

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. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary tramadol consumption tramadol consumption amounts were 0-1 hours, 1-12 hours, 12-24 hours 24 hours
Primary 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 24 hours
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