Trial Outcomes & Findings for Local Injection of Local Anesthetic 24 Hours After Knee Replacement Surgery May Decrease Pain for Several More Hours (NCT NCT02420951)

Results Overview

Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

7 days

Results posted on

2018-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	Injection Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.	No Injection Will not receive injection of bupivacaine prior to catheter removal No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Local Injection of Local Anesthetic 24 Hours After Knee Replacement Surgery May Decrease Pain for Several More Hours

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Injection n=25 Participants Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.	No Injection n=25 Participants Will not receive injection of bupivacaine prior to catheter removal No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.	Total n=50 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	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Age, Continuous	68.96 years n=5 Participants	66.44 years n=7 Participants	67.7 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain.

Outcome measures

Outcome measures
Measure	Injection n=25 Participants Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.	No Injection n=25 Participants Will not receive injection of bupivacaine prior to catheter removal No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
Pain Assessed Using the VAS 0-10 Pain Scale	2.763 units on a scale Interval 1.99 to 3.33	2.483 units on a scale Interval 1.89 to 2.89

SECONDARY outcome

Timeframe: 2 days

Questionnaire/Hospital Records - While patients are in the hospital, pain medication consumption will be tracked in their electronic medical record. At home, patients will be asked to keep a log of pain medication consumption. They will be asked to record this information on a questionnaire at their first post-operative visit.

Outcome measures

Outcome measures
Measure	Injection n=25 Participants Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.	No Injection n=25 Participants Will not receive injection of bupivacaine prior to catheter removal No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
Pain Med Consumption Assessed Using Questionnaire/Hospital Records	79.45548 morphine milligram equivalents (mgs) Interval 9.0 to 185.64	62.39041 morphine milligram equivalents (mgs) Interval 5.0 to 212.5

SECONDARY outcome

Timeframe: 7 days

Population: Data were not collected.

Total pain medications consumed by the patient, determined through the patients' own records in the questionnaire as well as hospital records of pain med administration and prescription.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Population: Data were not collected.

Swelling in the affected TKR joint, as measured by a perometer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Population: Data were not collected.

Proprioception measured after surgery, as measured by an SD balancer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Population: Data were not collected.

Quadriceps strength after surgery, as measured by a Biodex handheld dynamometer.

Outcome measures

Outcome data not reported

Adverse Events

Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wolfgang Fitz

Brigham and Women's Hospital

Phone: 6177329501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place