NCT05956275

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 4, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

Postoperative painAdductor canal blockInfiltration popliteal artery capsule knee blockTramadolBupivacaine

Outcome Measures

Primary Outcomes (2)

  • tramadol consumption

    tramadol consumption amounts were 0-1 hours, 1-12 hours, 12-24 hours

    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

    24 hours

Study Arms (2)

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.

Drug: TramadolDrug: Morfin

Control

SHAM COMPARATOR

No block performed

Drug: TramadolDrug: Morfin

Interventions

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.

Controladductor canal block and infiltration popliteal artery capsule knee block
MorfinDRUG

No block was applied to the patients in control

Controladductor canal block and infiltration popliteal artery capsule knee block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Location

Related 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Kutay Engin Özturan, Professor

    Bolu Abant İzzet Baysal University

    STUDY CHAIR
  • Cengiz Işık, Professor

    Bolu Abant İzzet Baysal University

    STUDY CHAIR
  • Asım İlker İtal, MD

    Bolu Abant İzzet Baysal University

    STUDY CHAIR
  • Mustafa Türkoğlu, MD

    Bolu Abant İzzet Baysal University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Spesialist Doctor

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 21, 2023

Study Start

December 8, 2020

Primary Completion

October 1, 2021

Study Completion

October 2, 2021

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

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.

Locations