CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
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 +2 moredrug
Likely dose
0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02860949
NCT02860949Phase 2Completed
CompareCT.gov

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

Thammasat University·interventional·Posted Aug 10, 2016·Updated Oct 25, 2016

In Brief

A Phase 2 clinical trial evaluating 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), and 1 other intervention for Osteoarthritis, Knee. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesThailand
CollaboratorsBoontanapibul, Krit, M.D.

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 10, 2016
Enrollment StartApr 1, 2014
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.9 years ago

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 mLdrug

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

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