Trial Outcomes & Findings for Periarticular Multimodal Drug Injections in Total Knee Arthroplasty (NCT NCT00901628)

Results Overview

An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

101 participants

Primary outcome timeframe

the night after surgery

Results posted on

2013-01-25

Participant Flow

101 patients who were scheduled for unilateral total knee arthroplasty recruitment at Joint Reconstruction Center, Seoul National University Bundang hospital from April 2008 to March 2009 were recruited.

no participant was excluded before assignment

Participant milestones

Participant milestones
Measure	Periarticular Injection Group Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group usual postoperative care using the continuous femoral nerve block, IV-PCA and preemptive oral medications without periarticular injection
Overall Study STARTED	49	52
Overall Study COMPLETED	45	42
Overall Study NOT COMPLETED	4	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Periarticular Injection Group Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group usual postoperative care using the continuous femoral nerve block, IV-PCA and preemptive oral medications without periarticular injection
Overall Study disconnection of catheter	4	8
Overall Study disconnection of drain	0	1
Overall Study peroneal nerve palsy	0	1

Baseline Characteristics

Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Periarticular Injection Group n=49 Participants Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group n=52 Participants usual postoperative care without periarticular injection	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	44 Participants n=7 Participants	84 Participants n=5 Participants
Age Continuous	70.2 years STANDARD_DEVIATION 7.1 • n=5 Participants	70.1 years STANDARD_DEVIATION 4.9 • n=7 Participants	70.1 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	48 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Korea, Republic of	49 participants n=5 Participants	52 participants n=7 Participants	101 participants n=5 Participants

PRIMARY outcome

Timeframe: the night after surgery

An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.

Outcome measures

Outcome measures
Measure	Periarticular Injection Group n=49 Participants Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group n=52 Participants usual postoperative care without periarticular injection
Pain( Visual Analog Scale )	2.3 units on a scale Standard Deviation 3.2	6.4 units on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 24 hours postoperative

Fentanyl based PCA consumption via PCA pump (microgram)

Outcome measures

Outcome measures
Measure	Periarticular Injection Group n=49 Participants Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group n=52 Participants usual postoperative care without periarticular injection
Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery	169.4 microgram Standard Deviation 273.9	262.3 microgram Standard Deviation 200.2

SECONDARY outcome

Timeframe: 24 hours after surgery

An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth.

Outcome measures

Outcome measures
Measure	Periarticular Injection Group n=49 Participants Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group n=52 Participants usual postoperative care without periarticular injection
Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery	22 participants	15 participants

SECONDARY outcome

Timeframe: postoperative 7 day

Outcome measures

Outcome measures
Measure	Periarticular Injection Group n=49 Participants Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group n=52 Participants usual postoperative care without periarticular injection
the Proportion of Patients Who Were Satisfied With the Pain Management	38 participants	39 participants

SECONDARY outcome

Timeframe: 24 hours postoperative

Outcome measures

Outcome measures
Measure	Periarticular Injection Group n=49 Participants Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group n=52 Participants usual postoperative care without periarticular injection
The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended	18 participants	6 participants

SECONDARY outcome

Timeframe: postoperative 7 day

An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day

Outcome measures

Outcome measures
Measure	Periarticular Injection Group n=49 Participants Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group n=52 Participants usual postoperative care without periarticular injection
Maximal Flexion Angle Degree on Postoperative 7 Day	92.3 degree Standard Deviation 17.3	95.2 degree Standard Deviation 13.7

Adverse Events

Periarticular Injection Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Injection Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Periarticular Injection Group n=49 participants at risk Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	No Injection Group n=52 participants at risk usual postoperative care without periarticular injection
Musculoskeletal and connective tissue disorders participant number of postoperative wound infection	0.00% 0/49 • within postoperative 30 days	0.00% 0/52 • within postoperative 30 days

Other adverse events

Adverse event data not reported

Additional Information

Tae Kyun Kim

Joint Reconstruction Center, Seoul National University Bundang Hospital

Phone: 82-31-787-7196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place