Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?

NCT02860949 | Completed Phase 2 DMC

• 1 other identifier: MTU-EC-OT-6-130/57
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Multimodal local anesthetic infiltration (LAI) provides effective pain control in patients undergoing total knee arthroplasty (TKA). Some surgeons avoid posterior capsular infiltration (PCI) for fear of damaging posterior neurovascular structures. Data are limited on the added benefits of PCI using different combinations of local anesthetic agents. Therefore, the investigator wanted to know the effectiveness of pain control in LAI with and without PCI. Half of participants received LAI with PCI, while the other half received LAI without PCI during total knee arthroplasty.

Conditions

Osteoarthritis, Knee

Keywords

Local anesthetic infiltration; Posterior capsular infiltration; Multimodal anesthesia; Knee arthroplasty; Pain control; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• The visual analogue scale (VAS) for pain

  24 hours after the operation

Secondary Outcomes (2)

• Morphine consumption from patient controlled analgesia (PCA)

  24 hours after the operation

• The visual analogue scale (VAS) for satisfaction

  24 hours after the operation

Study Arms (2)

LAI with PCI

EXPERIMENTAL

Local anesthetic infiltration with posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area, Lateral gutter area and Posterior capsular area)

Drug: 0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL; Procedure: Drug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL)

LAI without PCI

ACTIVE COMPARATOR

Local anesthetic infiltration without posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area and Lateral gutter area)

Drug: 0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL; Procedure: Drug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL

Interventions

0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL DRUG

LAI with PCI; LAI without PCI

Drug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL) PROCEDURE

LAI with PCI

Drug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL PROCEDURE

LAI without PCI

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.

You may not qualify if:

• Previous drug dependency
• Inability to undergo a spinal block
• Allergy to study drugs
• Renal insufficiency
• Abnormal liver function
• History of stroke
• History of coronary artery disease

Sponsors & Collaborators

• Thammasat University: lead
• Boontanapibul, Krit, M.D.: collaborator

Study Sites (1)

Thammasat university hospital

Pathum Thani, Klongluang, 12120, Thailand

Location

Related Publications (16)

• Safa B, Gollish J, Haslam L, McCartney CJ. Comparing the effects of single shot sciatic nerve block versus posterior capsule local anesthetic infiltration on analgesia and functional outcome after total knee arthroplasty: a prospective, randomized, double-blinded, controlled trial. J Arthroplasty. 2014 Jun;29(6):1149-53. doi: 10.1016/j.arth.2013.11.020. Epub 2013 Dec 2.

  PMID: 24559684 BACKGROUND

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  PMID: 15513495 RESULT

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  PMID: 2367246 RESULT

• Maheshwari AV, Blum YC, Shekhar L, Ranawat AS, Ranawat CS. Multimodal pain management after total hip and knee arthroplasty at the Ranawat Orthopaedic Center. Clin Orthop Relat Res. 2009 Jun;467(6):1418-23. doi: 10.1007/s11999-009-0728-7. Epub 2009 Feb 13.

  PMID: 19214642 RESULT

• Pettine KA, Wedel DJ, Cabanela ME, Weeks JL. The use of epidural bupivacaine following total knee arthroplasty. Orthop Rev. 1989 Aug;18(8):894-901.

  PMID: 2771438 RESULT

• Mahoney OM, Noble PC, Davidson J, Tullos HS. The effect of continuous epidural analgesia on postoperative pain, rehabilitation, and duration of hospitalization in total knee arthroplasty. Clin Orthop Relat Res. 1990 Nov;(260):30-7.

  PMID: 1977542 RESULT

• Cook P, Stevens J, Gaudron C. Comparing the effects of femoral nerve block versus femoral and sciatic nerve block on pain and opiate consumption after total knee arthroplasty. J Arthroplasty. 2003 Aug;18(5):583-6. doi: 10.1016/s0883-5403(03)00198-0.

  PMID: 12934209 RESULT

• Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, Bouaziz H, Samii K. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline Service. Anesthesiology. 2002 Nov;97(5):1274-80. doi: 10.1097/00000542-200211000-00034.

  PMID: 12411815 RESULT

• Liu SS, Zayas VM, Gordon MA, Beathe JC, Maalouf DB, Paroli L, Liguori GA, Ortiz J, Buschiazzo V, Ngeow J, Shetty T, Ya Deau JT. A prospective, randomized, controlled trial comparing ultrasound versus nerve stimulator guidance for interscalene block for ambulatory shoulder surgery for postoperative neurological symptoms. Anesth Analg. 2009 Jul;109(1):265-71. doi: 10.1213/ane.0b013e3181a3272c.

  PMID: 19535720 RESULT

• Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.

  PMID: 16651569 RESULT

• Ben-David B. Complications of regional anesthesia: an overview. Anesthesiol Clin North Am. 2002 Sep;20(3):665-667, ix. doi: 10.1016/s0889-8537(02)00003-2.

  PMID: 12298311 RESULT

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  PMID: 25302181 RESULT

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  PMID: 11133630 RESULT

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  PMID: 25187581 RESULT

• Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.

  PMID: 16452738 RESULT

• Krenzel BA, Cook C, Martin GN, Vail TP, Attarian DE, Bolognesi MP. Posterior capsular injections of ropivacaine during total knee arthroplasty: a randomized, double-blind, placebo-controlled study. J Arthroplasty. 2009 Sep;24(6 Suppl):138-43. doi: 10.1016/j.arth.2009.03.014. Epub 2009 Jun 10.

  PMID: 19520544 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Interventions

Bupivacaine; Morphine; Epinephrine; Ketorolac

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring

Study Officials

• Piya Pinsornsak, MD

  Faculty of Medicine, Thammasat university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2016
• First Posted: August 10, 2016
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)