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Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block After TKA

A Randomized Study of Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block for Postoperative Analgesia After Total Knee Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02730728
Enrollment
159
Registered
2016-04-06
Start date
2015-11-01
Completion date
2017-01-01
Last updated
2018-10-31

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

Conditions

Osteoarthritis, Post Operative Pain Control, Total Knee Arthroplasty

Keywords

adductor canal block, tinetti score, time to up and go test, Ambulation distance, pain score, quality of recovery score

Brief summary

The purpose of this study is to compare a single shot block, 24 hours, and 48 hour continuous catheter nerve block done via the adductor canal method in adult patients who have under gone total knee arthroplasty. Visual analogue scores, opioid consumption, time to up and go, ambulation, manual muscle tests, and Tinetti scores up to 72 hours post operatively will be used for comparison.

Detailed description

If the patient is willing to participate and signs the consent, he/she will be randomized to one of the three treatment groups: 1. Single shot block 2. 24 hour catheter 3. 48 hour catheter The choice of anesthetic technique will be at the discretion of the anesthesiologist. In our institution we usually advocate for spinal anesthesia for total knee arthroplasty. All patients will receive their multimodal perioperative pain protocol (MP3) medication as per protocol in the patient receiving area (400 mg of gabapentin, 200 mg of Celecoxib, and 1gm of acetaminophen). Patients will be monitored during block performance with standard ASA monitors. All patients will be receiving 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation. Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite S nerve machine will be used with a high frequency linear (HFL) US probe with 6-13 MHZ frequency. Both single shot and continuous adductor canal block will be performed according to the standard operating practices in our department 4. Ultrasound survey at the medial part of the thigh will take place, halfway between the superior anterior iliac spine and the patella. In a short axis view, the femoral artery will be identified underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery. The needle will be introduced in-plane and 2 to 3 mL of local anesthesia bolus will be used to verify correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal. For single shot blocks: A bolus of total volume of 20 ml of ropivicaine 0.5% will be injected through the needle. For the continuous block: The catheter will be introduced and advanced 2-3 cm beyond the tip of the needle under ultrasound visualization. The needle was withdrawn over the catheter. Injection of a bolus of 5 ml of ropivacaine 0.5% will take place through the catheter while observing the spread of local anesthetic under ultrasound. The catheter hub will be affixed to the upper lateral thigh with sterile occlusive dressings and an anchoring device. Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad in the saphenous nerve distribution over the medial leg within 30min after injection. Subjects with successful catheter placement per protocol and nerve block onset were retained in the study. Subjects with a failed catheter insertion or misplaced catheter indicated by a lack of sensory changes had their catheter replaced or were withdrawn from the study. At the conclusion of surgery, the catheters will be connected to a pump that will infuse local anesthetic. Ropivicaine 0.2% at 8 ml/hour. In the postoperative anesthesia care unit, intermittent boluses of hydromorphone will be used as needed. Postoperative analgesia will follow the MP3 protocol. Drugs that are used for the multimodal analgesia protocol include acetaminophen (1 gm every 8 hours for 72 hours), celecoxib (200 mg every 8 hours for 72 hours), Gabapentin (300 mg every 8 hours for one week if the patient is opioid naïve and for two weeks if patients are opioid tolerant), and oxycodone (5-10-15 mg oral as needed every 4 hours for pain based on patient reported pain score). All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV include administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl.

Interventions

Local anesthetic

DRUG0.2% Ropivicaine at 8 milliliter/hour

Local anesthetic

DRUG5ml bolus of 0.5% ropivicaine

Local anesthetic

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Patients scheduled for primary total knee arthroplasty * American Society of Anesthesiologists (ASA) physical status I -III * mentally competent and able to give consent for enrollment in the study

Exclusion criteria

* Patient younger than 18 years old * Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3) * Revision surgery * Impaired kidney functions and patient with coagulopathy * Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery * BMI of 40 or more * Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)

Design outcomes

Primary

MeasureTime frameDescription
Patients With Severe Pain at 48 Hours After Surgery48 hoursThe proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day

Secondary

MeasureTime frameDescription
Pain Scores at 48 Hours After Surgery48 hoursAverage pain scores 48 hours after surgery. The scale used is the numeric rating pain scale. The scale values range from 0-10/ where 0 is no pain and 10 is the worst pain possible imagined on this scale
Functional Recovery After Surgery48 hoursCumulative ambulation distance in the second postoperative day measured in feet
Patient-oriented Outcomes48 hoursQuality of recovery (QoR)-9 score on the second day after surgery. This score is a result of a 9 item questionnaire. Answers to each item/question is scored as (0-1-2). The wort score a patient get in the questionnaire is 0 and the best score is 18, depending on the answer of each of the 9 questions and the sum of the scores of these answers

Countries

United States

Participant flow

Participants by arm

ArmCount
Single Shot Adductor Canal Block
adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic
53
24 Hour Continuous Adductor Canal Block
adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic
51
48 Hour Continuous Adductor Canal Block
adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic
52
Total156

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLack of Efficacy011
Overall StudyWithdrawal by Subject010

Baseline characteristics

CharacteristicSingle Shot Adductor Canal Block24 Hour Continuous Adductor Canal Block48 Hour Continuous Adductor Canal BlockTotal
Age, Continuous63.9 years
STANDARD_DEVIATION 9.6
66.5 years
STANDARD_DEVIATION 8.5
62.2 years
STANDARD_DEVIATION 8.7
64 years
STANDARD_DEVIATION 9
Sex: Female, Male
Female
16 Participants22 Participants18 Participants56 Participants
Sex: Female, Male
Male
37 Participants29 Participants34 Participants100 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 530 / 510 / 52
serious
Total, serious adverse events
0 / 530 / 510 / 52

Outcome results

Primary

Patients With Severe Pain at 48 Hours After Surgery

The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day

Time frame: 48 hours

ArmMeasureValue (NUMBER)
Single Shot Adductor Canal BlockPatients With Severe Pain at 48 Hours After Surgery21 percentage of patients with severe pain
24 Hour Continuous Adductor Canal BlockPatients With Severe Pain at 48 Hours After Surgery14 percentage of patients with severe pain
48 Hour Continuous Adductor Canal BlockPatients With Severe Pain at 48 Hours After Surgery12 percentage of patients with severe pain
Secondary

Functional Recovery After Surgery

Cumulative ambulation distance in the second postoperative day measured in feet

Time frame: 48 hours

Population: cumulative ambulation distance in second day after surgery

ArmMeasureValue (MEDIAN)
Single Shot Adductor Canal BlockFunctional Recovery After Surgery155 Feet
24 Hour Continuous Adductor Canal BlockFunctional Recovery After Surgery150 Feet
48 Hour Continuous Adductor Canal BlockFunctional Recovery After Surgery200 Feet
Secondary

Pain Scores at 48 Hours After Surgery

Average pain scores 48 hours after surgery. The scale used is the numeric rating pain scale. The scale values range from 0-10/ where 0 is no pain and 10 is the worst pain possible imagined on this scale

Time frame: 48 hours

ArmMeasureValue (MEAN)Dispersion
Single Shot Adductor Canal BlockPain Scores at 48 Hours After Surgery5 units on a scale ( Pain score)Standard Deviation 2
24 Hour Continuous Adductor Canal BlockPain Scores at 48 Hours After Surgery4.3 units on a scale ( Pain score)Standard Deviation 2.5
48 Hour Continuous Adductor Canal BlockPain Scores at 48 Hours After Surgery3.9 units on a scale ( Pain score)Standard Deviation 2.4
Secondary

Patient-oriented Outcomes

Quality of recovery (QoR)-9 score on the second day after surgery. This score is a result of a 9 item questionnaire. Answers to each item/question is scored as (0-1-2). The wort score a patient get in the questionnaire is 0 and the best score is 18, depending on the answer of each of the 9 questions and the sum of the scores of these answers

Time frame: 48 hours

ArmMeasureValue (MEDIAN)
Single Shot Adductor Canal BlockPatient-oriented Outcomes12 units on a scale ( QoR score)
24 Hour Continuous Adductor Canal BlockPatient-oriented Outcomes13 units on a scale ( QoR score)
48 Hour Continuous Adductor Canal BlockPatient-oriented Outcomes13 units on a scale ( QoR score)

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