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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by North York General Hospital
Sponsor:
Information provided by (Responsible Party):
Mona Sawhney, North York General Hospital
ClinicalTrials.gov Identifier:
NCT01797588
First received: February 20, 2013
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Total Knee Arthroplasty
Postoperative Pain
Procedure: Adductor-canal block
Procedure: Periarticular infiltration
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by North York General Hospital:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: Post-operative day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: on post-operative day 1 and day 2 ] [ Designated as safety issue: Yes ]
    This will be measured using the BPI-interference subscale.


Estimated Enrollment: 96
Study Start Date: March 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: adductor-canal block and periarticular infiltration
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.
Procedure: Adductor-canal block
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.
Procedure: Periarticular infiltration
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.
Active Comparator: adductor-canal block
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.
Procedure: Adductor-canal block
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.
Active Comparator: periarticular infusion group
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.
Procedure: Periarticular infiltration
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.

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:

  1. pain at rest on post-operative day 1 and day 2 at 1000
  2. pain with walking on post-operative day 2
  3. pain with knee flexion on post-operative day 1 and day 2 at 1000
  4. analgesic consumption on post-operative day 1 and day 2
  5. distance walked on post-operative day 1 and day 2
  6. pain related interference with activities on post-operative day 1 and day 2
  7. length of stay
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797588

Contacts
Contact: Mona Sawhney, PhD 416-756-6000 ext 4988 mona.sawhney@nygh.on.ca
Contact: Brian Kashin 416-756-6000 ext 6520 bkashin@me.com

Locations
Canada, Ontario
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Sponsors and Collaborators
North York General Hospital
Investigators
Principal Investigator: Monakshi Sawhney, PhD North York General Hospital
  More Information

No publications provided

Responsible Party: Mona Sawhney, Dr. Mona Sawhney, NP, North York General Hospital
ClinicalTrials.gov Identifier: NCT01797588     History of Changes
Other Study ID Numbers: NYGHTKA-01
Study First Received: February 20, 2013
Last Updated: February 21, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by North York General Hospital:
Total Knee Arthroplasty
Pain
Periarticular infiltration
Adductor canal block
Postoperative

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014