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Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial

Randomized Comparative Effectiveness Trial of Anesthesia/Analgesia Techniques for Primary Total Knee Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02773537
Enrollment
75
Registered
2016-05-16
Start date
2015-10-31
Completion date
2016-11-30
Last updated
2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee

Brief summary

The primary aim of this pilot study will be to develop a clinically meaningful, patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of different strategies for achievement of the ideal balance between analgesia and functional mobility following total knee arthroplasty (TKA).

Detailed description

Pain management for total knee replacement (TKR) patients has evolved rapidly over the previous decade. The most recent advances in anesthesia include peripheral nerve blockade, which offers the promise of earlier postoperative mobilization in addition to effective pain relief. The rapidity with which these advancements have been adopted seems to have outpaced the science to support them. The result has been the institution of countless combinations of perioperative pain management strategies in centers nationwide with little standardization, consistency, or objective evidence. The extent to which these various strategies achieve safe and effective perioperative pain control or functional preservation remains poorly defined. This prospective randomized control trial will aim to identify meaningful patient-centric outcome measures, differentiate from among three perioperative TKR anesthetic and analgesic strategies, and provide a template for interdisciplinary collaboration among orthopedic surgeons, anesthesiologists, physical therapists, and patients. With the knowledge gained further study will continue to refine the most optimal early pain control protocol. All primary TKR patients undergoing surgery at the Medical University of South Carolina who are able to receive spinal anesthesia will be randomized prior to surgery to one of three forms of lower limb nerve blockade: 1) Continuous femoral nerve catheter plus single injection sciatic nerve block, 2) Adductor canal catheter plus selective tibial nerve block, 3) Adductor canal catheter alone. All patients will receive additional standardized pain medications as well as early mobilization with physical therapy. The primary outcome measure will be postoperative visual analog pain scale (VAS), with secondary measures to include validated patient-reported outcome measures, objective functional measures (timed-up-and-go (TUG), patient satisfaction scores, length of stay, discharge disposition, and complications. The investigators plan to enroll approximately 90 patients. This will allow us to reach our randomization goal of at least 75 patients while taking into account withdrawals. The 75 patients will be randomized into the three treatment three treatment arms over a 6-month recruitment period, with a 3 month follow-up for patient reported outcome and satisfaction data. A focus group will facilitate patient engagement and provide information for generation of a preference survey to guide future study design.

Interventions

DRUGFemoral nerve catheter and sciatic nerve block

This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

DRUGAdductor canal catheter and selective tibial block

This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

DRUGAdductor canal catheter only

This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Males and Females 18 years of age or older * Undergoing elective primary total knee arthroplasty * Patient is willing and able to give consent and participate

Exclusion criteria

* Inability to receive spinal anesthesia or peripheral nerve block * Non-ambulatory patients * Non- English speaking patients * Vulnerable populations including prisoners

Design outcomes

Primary

MeasureTime frameDescription
Pain Measurement Via VAS (Visual Analog Scale)48 hours after procedureThe primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.

Secondary

MeasureTime frameDescription
Functional Outcome Measures- Exstension/Knee Buckling1-2 days after procedureFunctional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. They will document the patient's ability to perform independent terminal knee extension and grade knee buckling with ambulation on a scale of 0-2 during each encounter. A grade of 0 indicates no knee buckling, 1 indicates slight buckling, and a grade of 2 represents knee buckling significant enough in the opinion of the physical therapist to require a knee immobilizer while ambulating. I higher score corresponds to a worse outcome. The numbers below in the outcome measure table are the number of patients who achieved terminal knee extension for had ANY knee buckling respectively.
Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)Morning of post-op day 1 - 2 days after procedureFunctional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #1, the therapist will calculate the Activity Measure for Post-Acute Care (AM-PAC) score. The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities,and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.
Narcotic Requirements48 hours after procedureNarcotic dosages will be measured and reported as oral morphine milligram equivalents.
Functional Outcome Measures- TUG (Timed Up and Go)- Time in SecondsMorning of post-op day 1 - 2 days after procedureFunctional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document a timed up-and-go test (TUG).
Patient Reported Pain and Function Outcomes6 Weeks after procedureShort Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20 and the max is 100. Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).
Functional Outcome Measures- TUG (Timed Up and Go)- Distance WalkedMorning of post-op day 1 - 2 days after procedureFunctional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document distance walked by the patient.

Countries

United States

Participant flow

Recruitment details

Recruitment occurred between October 2015 and August 2016. Patients were approached for participation in the study during their pre-op medical clearance clinic appointment.

Pre-assignment details

A total of 107 patients undergoing primary TKA met initial eligibility criteria and were offered participation in the trial. 75 total subjects were randomized and considered enrolled to one of three arms of the study. 32 patients were excluded for various reasons prior to randomization.

Participants by arm

ArmCount
Femoral Nerve Catheter and Sciatic Nerve Block
Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.
25
Adductor Canal Catheter and Selective Tibial Block
Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.
25
Adductor Canal Catheter Only
Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
25
Total75

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up014

Baseline characteristics

CharacteristicFemoral Nerve Catheter and Sciatic Nerve BlockAdductor Canal Catheter and Selective Tibial BlockAdductor Canal Catheter OnlyTotal
Age, Continuous60.1 years
STANDARD_DEVIATION 6.1
65.7 years
STANDARD_DEVIATION 9.5
65.6 years
STANDARD_DEVIATION 6.8
63.8 years
STANDARD_DEVIATION 7.5
Baseline VAS Pain Score5 Score on a scale6 Score on a scale6 Score on a scale6 Score on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants9 Participants7 Participants23 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
18 Participants16 Participants18 Participants52 Participants
Region of Enrollment
United States
25 participants25 participants25 participants75 participants
Sex: Female, Male
Female
15 Participants11 Participants11 Participants37 Participants
Sex: Female, Male
Male
10 Participants14 Participants14 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 250 / 25
other
Total, other adverse events
2 / 255 / 252 / 25
serious
Total, serious adverse events
0 / 250 / 250 / 25

Outcome results

Primary

Pain Measurement Via VAS (Visual Analog Scale)

The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.

Time frame: 48 hours after procedure

ArmMeasureValue (MEAN)Dispersion
Femoral Nerve Catheter and Sciatic Nerve BlockPain Measurement Via VAS (Visual Analog Scale)4.11 score on a scaleStandard Deviation 0.43
Adductor Canal Catheter and Selective Tibial BlockPain Measurement Via VAS (Visual Analog Scale)4.68 score on a scaleStandard Deviation 0.44
Adductor Canal Catheter OnlyPain Measurement Via VAS (Visual Analog Scale)4.36 score on a scaleStandard Deviation 0.42
Secondary

Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)

Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #1, the therapist will calculate the Activity Measure for Post-Acute Care (AM-PAC) score. The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities,and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.

Time frame: Morning of post-op day 1 - 2 days after procedure

ArmMeasureValue (MEAN)Dispersion
Femoral Nerve Catheter and Sciatic Nerve BlockFunctional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)15.0 score on a scaleStandard Deviation 2
Adductor Canal Catheter and Selective Tibial BlockFunctional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)16.5 score on a scaleStandard Deviation 4
Adductor Canal Catheter OnlyFunctional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)16.0 score on a scaleStandard Deviation 2
Secondary

Functional Outcome Measures- Exstension/Knee Buckling

Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. They will document the patient's ability to perform independent terminal knee extension and grade knee buckling with ambulation on a scale of 0-2 during each encounter. A grade of 0 indicates no knee buckling, 1 indicates slight buckling, and a grade of 2 represents knee buckling significant enough in the opinion of the physical therapist to require a knee immobilizer while ambulating. I higher score corresponds to a worse outcome. The numbers below in the outcome measure table are the number of patients who achieved terminal knee extension for had ANY knee buckling respectively.

Time frame: 1-2 days after procedure

ArmMeasureGroupValue (NUMBER)
Femoral Nerve Catheter and Sciatic Nerve BlockFunctional Outcome Measures- Exstension/Knee BucklingTerminal Knee Extension (Yes) (Post Op. Day 2)13 number of participants
Femoral Nerve Catheter and Sciatic Nerve BlockFunctional Outcome Measures- Exstension/Knee BucklingAny Knee Buckling (Yes) (Post Op. Day 1)20 number of participants
Femoral Nerve Catheter and Sciatic Nerve BlockFunctional Outcome Measures- Exstension/Knee BucklingTerminal Knee Extension (YES)(Post Op Day 1)10 number of participants
Femoral Nerve Catheter and Sciatic Nerve BlockFunctional Outcome Measures- Exstension/Knee BucklingAny Knee Buckling (Yes) (PPost Op. Day 2)8 number of participants
Adductor Canal Catheter and Selective Tibial BlockFunctional Outcome Measures- Exstension/Knee BucklingAny Knee Buckling (Yes) (Post Op. Day 1)7 number of participants
Adductor Canal Catheter and Selective Tibial BlockFunctional Outcome Measures- Exstension/Knee BucklingTerminal Knee Extension (Yes) (Post Op. Day 2)15 number of participants
Adductor Canal Catheter and Selective Tibial BlockFunctional Outcome Measures- Exstension/Knee BucklingAny Knee Buckling (Yes) (PPost Op. Day 2)4 number of participants
Adductor Canal Catheter and Selective Tibial BlockFunctional Outcome Measures- Exstension/Knee BucklingTerminal Knee Extension (YES)(Post Op Day 1)16 number of participants
Adductor Canal Catheter OnlyFunctional Outcome Measures- Exstension/Knee BucklingTerminal Knee Extension (YES)(Post Op Day 1)20 number of participants
Adductor Canal Catheter OnlyFunctional Outcome Measures- Exstension/Knee BucklingAny Knee Buckling (Yes) (PPost Op. Day 2)1 number of participants
Adductor Canal Catheter OnlyFunctional Outcome Measures- Exstension/Knee BucklingTerminal Knee Extension (Yes) (Post Op. Day 2)22 number of participants
Adductor Canal Catheter OnlyFunctional Outcome Measures- Exstension/Knee BucklingAny Knee Buckling (Yes) (Post Op. Day 1)8 number of participants
Secondary

Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked

Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document distance walked by the patient.

Time frame: Morning of post-op day 1 - 2 days after procedure

ArmMeasureValue (MEAN)Dispersion
Femoral Nerve Catheter and Sciatic Nerve BlockFunctional Outcome Measures- TUG (Timed Up and Go)- Distance Walked80 FeetStandard Deviation 102
Adductor Canal Catheter and Selective Tibial BlockFunctional Outcome Measures- TUG (Timed Up and Go)- Distance Walked155 FeetStandard Deviation 150
Adductor Canal Catheter OnlyFunctional Outcome Measures- TUG (Timed Up and Go)- Distance Walked160 FeetStandard Deviation 105
Secondary

Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds

Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document a timed up-and-go test (TUG).

Time frame: Morning of post-op day 1 - 2 days after procedure

ArmMeasureValue (MEAN)Dispersion
Femoral Nerve Catheter and Sciatic Nerve BlockFunctional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds66.1 secondsStandard Deviation 32
Adductor Canal Catheter and Selective Tibial BlockFunctional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds61.9 secondsStandard Deviation 29.6
Adductor Canal Catheter OnlyFunctional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds65.3 secondsStandard Deviation 39.3
Secondary

Narcotic Requirements

Narcotic dosages will be measured and reported as oral morphine milligram equivalents.

Time frame: 48 hours after procedure

ArmMeasureValue (MEAN)
Femoral Nerve Catheter and Sciatic Nerve BlockNarcotic Requirements90 milligrams of morphine equivalents
Adductor Canal Catheter and Selective Tibial BlockNarcotic Requirements107.5 milligrams of morphine equivalents
Adductor Canal Catheter OnlyNarcotic Requirements107 milligrams of morphine equivalents
Secondary

Patient Reported Pain and Function Outcomes

Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20 and the max is 100. Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).

Time frame: 6 Weeks after procedure

ArmMeasureGroupValue (MEAN)Dispersion
Femoral Nerve Catheter and Sciatic Nerve BlockPatient Reported Pain and Function OutcomesPROMIS37.4 score on a scaleStandard Deviation 4.76
Femoral Nerve Catheter and Sciatic Nerve BlockPatient Reported Pain and Function OutcomesKOOS Pain63.3 score on a scaleStandard Deviation 19
Femoral Nerve Catheter and Sciatic Nerve BlockPatient Reported Pain and Function OutcomesKOOS Symptom61.7 score on a scaleStandard Deviation 21.8
Adductor Canal Catheter and Selective Tibial BlockPatient Reported Pain and Function OutcomesKOOS Symptom62.6 score on a scaleStandard Deviation 16.9
Adductor Canal Catheter and Selective Tibial BlockPatient Reported Pain and Function OutcomesKOOS Pain57.8 score on a scaleStandard Deviation 17
Adductor Canal Catheter and Selective Tibial BlockPatient Reported Pain and Function OutcomesPROMIS41.5 score on a scaleStandard Deviation 6.35
Adductor Canal Catheter OnlyPatient Reported Pain and Function OutcomesPROMIS39.2 score on a scaleStandard Deviation 6.42
Adductor Canal Catheter OnlyPatient Reported Pain and Function OutcomesKOOS Pain62.6 score on a scaleStandard Deviation 15.8
Adductor Canal Catheter OnlyPatient Reported Pain and Function OutcomesKOOS Symptom58.7 score on a scaleStandard Deviation 13.2
Secondary

Patient Reported Pain and Function Outcomes

Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20, the maximum is 100. Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).

Time frame: 3 Months after Procedure

ArmMeasureGroupValue (MEAN)Dispersion
Femoral Nerve Catheter and Sciatic Nerve BlockPatient Reported Pain and Function OutcomesKOOS Symptom64.3 score on a scaleStandard Deviation 19
Femoral Nerve Catheter and Sciatic Nerve BlockPatient Reported Pain and Function OutcomesKOOS Pain66.8 score on a scaleStandard Deviation 19.8
Femoral Nerve Catheter and Sciatic Nerve BlockPatient Reported Pain and Function OutcomesPROMIS41.1 score on a scaleStandard Deviation 6.92
Adductor Canal Catheter and Selective Tibial BlockPatient Reported Pain and Function OutcomesKOOS Symptom71.7 score on a scaleStandard Deviation 12.9
Adductor Canal Catheter and Selective Tibial BlockPatient Reported Pain and Function OutcomesKOOS Pain72.6 score on a scaleStandard Deviation 18.4
Adductor Canal Catheter and Selective Tibial BlockPatient Reported Pain and Function OutcomesPROMIS45.4 score on a scaleStandard Deviation 7.17
Adductor Canal Catheter OnlyPatient Reported Pain and Function OutcomesKOOS Pain70.5 score on a scaleStandard Deviation 17.3
Adductor Canal Catheter OnlyPatient Reported Pain and Function OutcomesPROMIS44.4 score on a scaleStandard Deviation 6.04
Adductor Canal Catheter OnlyPatient Reported Pain and Function OutcomesKOOS Symptom67.4 score on a scaleStandard Deviation 15.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026