Efficacy of Pain Control in Different Bupivacaine Dose in Periarticular Injection in Bilateral Total Knee Arthroplasty

Efficacy of Pain Management in Different Concentrations of Bupivacaine in Periarticular Injection and Plasma Concentrations of Bupivacaine in Patients Undergoing Bilateral Knee Arthroplasty

To study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty.

To study plasma concentration of bupivacaine in patient who received spinal anesthesia and single shot bilateral adductor canal block and periarticular infiltration with bupivacaine for safety level.

Study Overview

• Status: Completed
• Conditions: Bilateral Total Knee Arthroplasty
• Intervention / Treatment: Drug: bupivacaine 100 mg; Procedure: bupivacaine 200 mg

Detailed Description

Adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia techniques is used for achieve this goal. multimodal analgesia for bilateral total knee arthroplasty are peripheral nerve block, periarticular infiltration, NSAIDs, gabapentins and others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular infiltration with bupivacaine so patient receive a large dose of bupivacaine. the investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for periarticular infiltration. and study plasma level of bupivacaine.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged more than 18 years old
• American society of anesthesiologists physical status classification 1-3
• Undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot bilateral adductor canal block

Exclusion Criteria:

• Allergy to bupivacaine
• Body weight less than 50 kilograms
• Hepatic disease
• Coagulopathy
• Creatinine clearance less than 60 ml/min
• Uncontrolled cerebrovascular disease
• Hematocrit less than 35%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bupivacaine 100 mg; bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add Normal saline solution(NSS) to 80 ml divided to two syringes for bilateral periarticular infiltration	Drug: bupivacaine 100 mg; bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
Active Comparator: bupivacaine 200 mg; bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration	Procedure: bupivacaine 200 mg; bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain score	Numerical rating scale at rest and movement in the first 24 hours postoperatively	0-24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma bupivacaine level	plasma bupivacaine level at 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltration	40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio
postoperative morphine consumption	postoperative morphine consumption at first 24 hours and 24-48 hours postoperatively	first 24 hours and 24-48 hours postoperatively
ambulation	patient can walk with assistances within 48 hours postoperatively	48 hours postoperatively

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: sukanya dej-arkom, MD, Mahidol University

Publications and helpful links

General Publications

• Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty:a prospective, randomized trial. J Arthroplasty. 2010 Sep;25(6):851-7. doi: 10.1016/j.arth.2009.09.007. Epub 2009 Dec 21.
• Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
• Dimitris CN, Taylor BC, Mowbray JG, Steensen RN, Gaines ST. Perioperative morbidity and mortality of 2-team simultaneous bilateral total knee arthroplasty. Orthopedics. 2011 Dec 6;34(12):e841-6. doi: 10.3928/01477447-20111021-02.
• Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.
• Lapmahapaisan S, Chinachoti T, Maisat W, Kleebchan N, Chatsiricharoenkul S, Charoencholvanich K, Rungwattanakij P, Sakulpacharoen N, Sri-In J. Plasma concentrations of bupivacaine after spinal anesthesia with single shot femoral nerve block and periarticular injection in total knee arthroplasty. J Med Assoc Thai. 2014 Jul;97(7):724-9.
• Koh IJ, Kang YG, Chang CB, Kwon SK, Seo ES, Seong SC, Kim TK. Additional pain relieving effect of intraoperative periarticular injections after simultaneous bilateral TKA: a randomized, controlled study. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):916-22. doi: 10.1007/s00167-010-1051-2. Epub 2010 Jan 30.
• Wulf H, Gleim M, Schele HA. Plasma concentrations of bupivacaine after lumbar sympathetic block. Anesth Analg. 1994 Nov;79(5):918-20. doi: 10.1213/00000539-199411000-00017. Erratum In: Anesth Analg 1995 Jul;81(1):213.
• Lapmahapaisan S, Chinachoti T, Kongpatanakul S, Chatsiricharoenkul S, Tovnich B, Duangkaew W, Pongnarin P, Sakulpacharoen N, Somcharoen W. Plasma concentrations of bupivacaine after spinal anesthesia with single shot femoral nerve block in total knee arthroplasty. J Med Assoc Thai. 2013 Mar;96(3):312-7.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2017
• Primary Completion (Actual): September 14, 2020
• Study Completion (Actual): September 14, 2020

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 12, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: postoperative pain management; periarticular infiltration; plasma level of bupivacaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: si111/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No