NCT03249662

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 27, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

August 10, 2017

Last Update Submit

September 14, 2020

Conditions

Bilateral Total Knee Arthroplasty

Keywords

periarticular infiltrationpostoperative pain managementplasma level of bupivacaine

Outcome Measures

Primary Outcomes (1)

  • postoperative pain score

    Numerical rating scale at rest and movement in the first 24 hours postoperatively

    0-24 hours postoperative

Secondary Outcomes (3)

  • plasma bupivacaine level

    40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio

  • postoperative morphine consumption

    first 24 hours and 24-48 hours postoperatively

  • ambulation

    48 hours postoperatively

Study Arms (2)

bupivacaine 100 mg

EXPERIMENTAL

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 200 mg

ACTIVE COMPARATOR

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

Interventions

bupivacaine 200 mgPROCEDURE

bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration

bupivacaine 200 mg
bupivacaine 100 mgDRUG

bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration

bupivacaine 100 mg

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (9)

  • 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.

    PMID: 22146199BACKGROUND

  • 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.

    PMID: 20022457BACKGROUND

  • 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.

    PMID: 15635516BACKGROUND

  • 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.

    PMID: 25265771BACKGROUND

  • 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.

    PMID: 19025523BACKGROUND

  • 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.

    PMID: 20119672BACKGROUND

  • 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.

    PMID: 7978410BACKGROUND

  • 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.

    PMID: 23539934BACKGROUND

  • Dej-Arkom S, Pangthipampai P, Chandranipapongse W, Chatsirichareonkul S, Narkbunnam R, Charoencholvanich K, Tangchittam S, Iamaroon A. Efficacy and safety of different bupivacaine concentrations in periarticular infiltration combined with adductor canal block for bilateral total knee arthroplasty: a randomized controlled trial. Knee Surg Relat Res. 2024 Jan 19;36(1):5. doi: 10.1186/s43019-024-00211-y.

    PMID: 38243272DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • sukanya dej-arkom, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 15, 2017

Study Start

September 27, 2017

Primary Completion

September 14, 2020

Study Completion

September 14, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

TH(1)