Trial Outcomes & Findings for Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty (NCT NCT00562627)

NCT ID: NCT00562627

Last Updated: 2011-08-08

Results Overview

VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 102 participants
• Primary outcome timeframe: 48 hours postoperative
• Results posted on: 2011-08-08

Participant Flow

Participant milestones

Measure	LIA IV (Local Infiltration Analgesia, Intravenous) Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine	LIA IA, (Local Infiltration Analgesia, Intra-articular) Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine	Epidural continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
Overall Study STARTED	34	34	34
Overall Study COMPLETED	33	33	33
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Measure	LIA IV (Local Infiltration Analgesia, Intravenous) Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine	LIA IA, (Local Infiltration Analgesia, Intra-articular) Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine	Epidural continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
Overall Study Protocol Violation	1	1	1

Baseline Characteristics

Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

Baseline characteristics by cohort

Measure	LIA IV (Local Infiltration Analgesia, Intravenous) n=34 Participants Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine	LIA IA, (Local Infiltration Analgesia, Intra-articular) n=34 Participants Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine	Epidural n=34 Participants continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml	Total n=102 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	47 Participants n=4 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	55 Participants n=4 Participants
Age Continuous	66.5 years STANDARD_DEVIATION 11 • n=5 Participants	67.2 years STANDARD_DEVIATION 8.9 • n=7 Participants	65.8 years STANDARD_DEVIATION 10.7 • n=5 Participants	66.5 years STANDARD_DEVIATION 9.9 • n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	65 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants
Region of Enrollment Norway	34 participants n=5 Participants	34 participants n=7 Participants	34 participants n=5 Participants	102 participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours postoperative

VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.

Outcome measures

Measure	LIA IV (Local Infiltration Analgesia, Intravenous) n=33 Participants Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine	LIA IA, (Local Infiltration Analgesia, Intra-articular) n=33 Participants Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine	Epidural n=33 Participants continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
Pain at Rest (VAS)	18 Units on a scale Standard Deviation 15	12 Units on a scale Standard Deviation 13	30 Units on a scale Standard Deviation 29

SECONDARY outcome

Timeframe: 48 hours postoperative

Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.

Outcome measures

Measure	LIA IV (Local Infiltration Analgesia, Intravenous) n=33 Participants Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine	LIA IA, (Local Infiltration Analgesia, Intra-articular) n=33 Participants Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine	Epidural n=33 Participants continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
Opioid Use	77 mg Standard Deviation 39	49 mg Standard Deviation 36	54 mg Standard Deviation 43

SECONDARY outcome

Timeframe: up to 10 days postoperative

Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.

Outcome measures

Measure	LIA IV (Local Infiltration Analgesia, Intravenous) n=33 Participants Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine	LIA IA, (Local Infiltration Analgesia, Intra-articular) n=33 Participants Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine	Epidural n=33 Participants continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
Time to Readiness for Discharge	4 days Standard Deviation 1.3	3.5 days Standard Deviation 0.7	5.5 days Standard Deviation 1.6

Adverse Events

LIA IV (Local Infiltration Analgesia, Intravenous)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LIA IA, (Local Infiltration Analgesia, Intra-articular)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epidural

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	LIA IV (Local Infiltration Analgesia, Intravenous) n=33 participants at risk Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine	LIA IA, (Local Infiltration Analgesia, Intra-articular) n=33 participants at risk Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine	Epidural n=33 participants at risk continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
Musculoskeletal and connective tissue disorders Knee infection	0.00% 0/33	0.00% 0/33	3.0% 1/33 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Ulrich Johannes Spreng

Baerum Hospital

Phone: 004798499184

Email: ulispreng@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place