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Pain After Total Knee Arthroplasty: A Trial Examining Combined Adductor-canal Nerve Block and Periarticular Infiltration Versus Adductor Canal Nerve Block Versus Periarticular Infiltration

Primary Purpose

Total Knee Arthroplasty, Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Adductor-canal block
Periarticular infiltration
Sponsored by
North York General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty focused on measuring Total Knee Arthroplasty, Pain, Periarticular infiltration, Adductor canal block, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 years or older
  • ASA I-III
  • eligible for spinal anesthetic
  • able to speak
  • read and understand English
  • willing to participate in the trial
  • will be discharged home.

Exclusion Criteria:

  • contraindication to regional anesthesia
  • have an allergy to local anesthetics
  • contradiction to NSAID's
  • have chronic pain that is not related to their knee joint
  • have been using opioids on a chronic basis (3 months or longer)
  • have a pre-existing peripheral neuropathy involving the operative site.

Sites / Locations

  • North York General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

adductor-canal block and periarticular infiltration

adductor-canal block

periarticular infusion group

Arm Description

Adductor-canal block,performed prior to surgery using ultra sound guidance by an anesthetist, with a total of 30mL of 0.33% ropivacaine injected into the area surrounding the saphenous nerve. Periarticular infiltration, performed intra-operatively by the surgeon, involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee.

The adductor-canal block only group will receive an adductor-canal block prior to surgery in the block room using ultra sound guidance by an anesthetist. After the adductor-canal is located a total of 30mL of 0.33% ropivacaine will be injected into the area surrounding the saphenous nerve. Participants will also receive 110mL of normal saline administered as follows: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues.

Periarticular infiltration,performed intra-operatively,involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. It will be administered as follows: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues.

Outcomes

Primary Outcome Measures

Pain Intensity
The primary outcome of this trial is to examine pain on walking, using a 0 to 10 numeric rating scale (NRS), at post-operative day 1 in patients who undergo TKA

Secondary Outcome Measures

pain related interference with activities
This will be measured using the BPI-interference subscale.

Full Information

First Posted
February 20, 2013
Last Updated
January 2, 2015
Sponsor
North York General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01797588
Brief Title
Pain After Total Knee Arthroplasty: A Trial Examining Combined Adductor-canal Nerve Block and Periarticular Infiltration Versus Adductor Canal Nerve Block Versus Periarticular Infiltration
Official Title
Pain After Total Knee Arthroplasty: A Randomized Controlled Trial Examining the Effectiveness of a Combined Adductor-canal Peripheral Nerve Block With Periarticular Infiltration Versus Adductor-canal Nerve Block Alone Versus Periarticular Infiltration Alone.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North York General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Effective pain management following total knee arthroplasty is important to facilitate early mobilization and rehabilitation. To manage post-operative pain, multimodal analgesia, including acetaminophen, NSAID's, gabapentin, opioids and local anesthetics are used. However, local anesthetics injected into the femoral nerve area may cause a block in motor function of the quadriceps muscle. Both adductor-canal peripheral nerve block performed pre-operatively, and periarticular infiltration performed intra-operatively are effective in reducing pain following TKA without causing quadriceps motor block which can impede mobilization. No published trials have been found that compare single shot adductor-canal block plus periarticular infiltration to periarticular infiltration only or adductor-canal nerve block only. The purpose of this trial is to examine the effect of 3 different approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2) adductor-canal block only; 3) periarticular infiltration only, on pain, analgesic consumption, mobility, pain related interference with activities and length of hospital stay in participants undergoing unilateral TKA. Patients will be eligible for participation if they are 18 years old or older, and can speak, and read English. Ninety-six trial participants will be randomized to receive 1 of the 3 approaches to nerve blockade as part of their pain management plan. Outcomes will be measured on post-operative days 1 and 2 and length of stay will be calculated in hours after the participant is discharged to home. It is hypothesized that participants that receive both adductor-canal nerve block plus periarticular infiltration will report less pain, improved mobility and less pain related interference with activities.
Detailed Description
Hypothesis: The combination of adductor-canal peripheral nerve block with periarticular intra-operative infiltration (AC+PI) provides superior analgesia and preserves motor function as compared to adductor-canal block (AC) only or periarticular infusion (PI) only. Specific Aims: The primary outcome of this trial is to examine pain on walking, using a 0 to 10 numeric rating scale (NRS), at post-operative day 1 in patients who undergo TKA using 3 different approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2) adductor-canal block only; 3) periarticular infiltration only. The secondary outcomes of this trial are to examine, in patients who undergo TKA using 3 different approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2) adductor-canal block only; 3) periarticular infiltration only: pain at rest on post-operative day 1 and day 2 at 1000 pain with walking on post-operative day 2 pain with knee flexion on post-operative day 1 and day 2 at 1000 analgesic consumption on post-operative day 1 and day 2 distance walked on post-operative day 1 and day 2 pain related interference with activities on post-operative day 1 and day 2 length of stay

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Postoperative Pain
Keywords
Total Knee Arthroplasty, Pain, Periarticular infiltration, Adductor canal block, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adductor-canal block and periarticular infiltration
Arm Type
Active Comparator
Arm Description
Adductor-canal block,performed prior to surgery using ultra sound guidance by an anesthetist, with a total of 30mL of 0.33% ropivacaine injected into the area surrounding the saphenous nerve. Periarticular infiltration, performed intra-operatively by the surgeon, involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee.
Arm Title
adductor-canal block
Arm Type
Active Comparator
Arm Description
The adductor-canal block only group will receive an adductor-canal block prior to surgery in the block room using ultra sound guidance by an anesthetist. After the adductor-canal is located a total of 30mL of 0.33% ropivacaine will be injected into the area surrounding the saphenous nerve. Participants will also receive 110mL of normal saline administered as follows: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues.
Arm Title
periarticular infusion group
Arm Type
Active Comparator
Arm Description
Periarticular infiltration,performed intra-operatively,involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. It will be administered as follows: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues.
Intervention Type
Procedure
Intervention Name(s)
Adductor-canal block
Intervention Description
The adductor-canal will be located via ultra sound and a total of 30mL of 0.33% ropivacaine will be injected into the area surrounding the saphenous nerve.
Intervention Type
Procedure
Intervention Name(s)
Periarticular infiltration
Intervention Description
Periarticular infiltration will be performed intra-operatively and involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. In each Knee: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
The primary outcome of this trial is to examine pain on walking, using a 0 to 10 numeric rating scale (NRS), at post-operative day 1 in patients who undergo TKA
Time Frame
Post-operative day 1
Secondary Outcome Measure Information:
Title
pain related interference with activities
Description
This will be measured using the BPI-interference subscale.
Time Frame
on post-operative day 1 and day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 years or older ASA I-III eligible for spinal anesthetic able to speak read and understand English willing to participate in the trial will be discharged home. Exclusion Criteria: contraindication to regional anesthesia have an allergy to local anesthetics contradiction to NSAID's have chronic pain that is not related to their knee joint have been using opioids on a chronic basis (3 months or longer) have a pre-existing peripheral neuropathy involving the operative site.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monakshi Sawhney, PhD
Organizational Affiliation
North York General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Pain After Total Knee Arthroplasty: A Trial Examining Combined Adductor-canal Nerve Block and Periarticular Infiltration Versus Adductor Canal Nerve Block Versus Periarticular Infiltration

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