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

Osteoarthritis, Knee Clinical Trial

Official title:

Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk? A Prospective, Double-Blind, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860949
• Other study ID #: MTU-EC-OT-6-130/57
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2016
• Last updated: October 22, 2016
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2016
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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)

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

Locations

Country	Name	City	State
Thailand	Thammasat university hospital	Pathumthani	Klongluang

Sponsors (2)

Lead Sponsor	Collaborator
Thammasat University	Krit Boontanapibul

Country where clinical trial is conducted

Thailand, 

References & Publications (16)

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. — View Citation

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. Erratum in: Anesthesiology. — View Citation

Ben-David B. Complications of regional anesthesia: an overview. Anesthesiol Clin North America. 2002 Sep;20(3):665-667, ix. Review. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 am — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Rasmussen S, Kramhøft 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. A — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The visual analogue scale (VAS) for pain		24 hours after the operation	No
Secondary	Morphine consumption from patient controlled analgesia (PCA)		24 hours after the operation	No
Secondary	The visual analogue scale (VAS) for satisfaction		24 hours after the operation	No