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

NCT01797588 | Completed Phase 4

• 1 other identifier: NYGHTKA-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Postoperative Pain

Keywords

Total Knee Arthroplasty; Pain; Periarticular infiltration; Adductor canal block; Postoperative

Outcome Measures

Primary Outcomes (1)

• 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

  Post-operative day 1

Secondary Outcomes (1)

• pain related interference with activities

  on post-operative day 1 and day 2

Study Arms (3)

adductor-canal block and periarticular infiltration

ACTIVE COMPARATOR

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; Procedure: Periarticular infiltration

adductor-canal block

ACTIVE COMPARATOR

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

periarticular infusion group

ACTIVE COMPARATOR

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

Interventions

Adductor-canal block PROCEDURE

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.

adductor-canal block; adductor-canal block and periarticular infiltration

Periarticular infiltration PROCEDURE

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.

adductor-canal block and periarticular infiltration; periarticular infusion group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North York General Hospital: lead

Study Sites (1)

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Monakshi Sawhney, PhD

  North York General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mona Sawhney, NP

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 22, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 5, 2015

Record last verified: 2015-01

Locations

CA (1)