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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Analgesic agents were bupivacaine, morphine, ketorolac and epinephrine. All patients received spinal anesthesia and patient controlled analgesia (PCA) for 24 hours post surgery. The surgical technique and postoperative medication protocols were identical in both groups. The visual analogue scale (VAS) for pain during activity and at rest, and morphine consumption were recorded at 6, 12, 18 and 24 hours postoperatively. LAI-related side effects, blood loss, length of hospital stay, and VAS for satisfaction were monitored. The reviewer was blinded to treatment groups.

Conditions

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Osteoarthritis, Knee

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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LAI with PCI

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Intervention Type PROCEDURE

LAI without PCI

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Intervention Type PROCEDURE

Interventions

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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

Intervention Type DRUG

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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piya pinsornsak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Piya Pinsornsak, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Thammasat university

Locations

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Thammasat university hospital

Pathum Thani, Klongluang, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND

PMID: 24559684 (View on PubMed)

Rasmussen S, Kramhoft MU, Sperling KP, Pedersen JH. Increased flexion and reduced hospital stay with continuous intraarticular morphine and ropivacaine after primary total knee replacement: open intervention study of efficacy and safety in 154 patients. Acta Orthop Scand. 2004 Oct;75(5):606-9. doi: 10.1080/00016470410001501.

Reference Type RESULT

PMID: 15513495 (View on PubMed)

Shoji H, Solomonow M, Yoshino S, D'Ambrosia R, Dabezies E. Factors affecting postoperative flexion in total knee arthroplasty. Orthopedics. 1990 Jun;13(6):643-9. doi: 10.3928/0147-7447-19900601-08.

Reference Type RESULT

PMID: 2367246 (View on PubMed)

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.

Reference Type RESULT

PMID: 19214642 (View on PubMed)

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.

Reference Type RESULT

PMID: 2771438 (View on PubMed)

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.

Reference Type RESULT

PMID: 1977542 (View on PubMed)

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.

Reference Type RESULT

PMID: 12934209 (View on PubMed)

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.

Reference Type RESULT

PMID: 12411815 (View on PubMed)

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.

Reference Type RESULT

PMID: 19535720 (View on PubMed)

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.

Reference Type RESULT

PMID: 16651569 (View on PubMed)

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.

Reference Type RESULT

PMID: 12298311 (View on PubMed)

Adibatti M, V S. Study on variant anatomy of sciatic nerve. J Clin Diagn Res. 2014 Aug;8(8):AC07-9. doi: 10.7860/JCDR/2014/9116.4725. Epub 2014 Aug 20.

Reference Type RESULT

PMID: 25302181 (View on PubMed)

Vloka JD, Hadzic A, April E, Thys DM. The division of the sciatic nerve in the popliteal fossa: anatomical implications for popliteal nerve blockade. Anesth Analg. 2001 Jan;92(1):215-7. doi: 10.1097/00000539-200101000-00041.

Reference Type RESULT

PMID: 11133630 (View on PubMed)

Tsukada S, Wakui M, Hoshino A. Postoperative epidural analgesia compared with intraoperative periarticular injection for pain control following total knee arthroplasty under spinal anesthesia: a randomized controlled trial. J Bone Joint Surg Am. 2014 Sep 3;96(17):1433-8. doi: 10.2106/JBJS.M.01098.

Reference Type RESULT

PMID: 25187581 (View on PubMed)

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.

Reference Type RESULT

PMID: 16452738 (View on PubMed)

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.

Reference Type RESULT

PMID: 19520544 (View on PubMed)

Other Identifiers

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MTU-EC-OT-6-130/57

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

LAI with PCI

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 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

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

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

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Boontanapibul, Krit, M.D.

Thammasat University

Responsible Party

piya pinsornsak

Principal Investigators

Piya Pinsornsak, MD

Locations

Thammasat university hospital

Countries

References

Shoji H, Solomonow M, Yoshino S, D'Ambrosia R, Dabezies E. Factors affecting postoperative flexion in total knee arthroplasty. Orthopedics. 1990 Jun;13(6):643-9. doi: 10.3928/0147-7447-19900601-08.

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.

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.

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.

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.

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.

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.

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.

Adibatti M, V S. Study on variant anatomy of sciatic nerve. J Clin Diagn Res. 2014 Aug;8(8):AC07-9. doi: 10.7860/JCDR/2014/9116.4725. Epub 2014 Aug 20.

Vloka JD, Hadzic A, April E, Thys DM. The division of the sciatic nerve in the popliteal fossa: anatomical implications for popliteal nerve blockade. Anesth Analg. 2001 Jan;92(1):215-7. doi: 10.1097/00000539-200101000-00041.

Tsukada S, Wakui M, Hoshino A. Postoperative epidural analgesia compared with intraoperative periarticular injection for pain control following total knee arthroplasty under spinal anesthesia: a randomized controlled trial. J Bone Joint Surg Am. 2014 Sep 3;96(17):1433-8. doi: 10.2106/JBJS.M.01098.

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.

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.

Other Identifiers

MTU-EC-OT-6-130/57