Completed

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.

What is being tested

Adductor-canal block

+ Periarticular infiltration

+ Adductor-canal block

Procedure

Who is being recruted

Neurologic Manifestations+4

+ Pathologic Processes

+ Postoperative Complications

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorNorth York General Hospital

Last updated: January 5, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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

NCT01797588

Principal SponsorNorth York General Hospital

Last updated: January 5, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

156 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsPainPain, Postoperative

Criteria

7 inclusion criteria required to participate

ASA I-III

able to speak

age 18 years or older

eligible for spinal anesthetic

Show More Criteria

6 exclusion criteria prevent from participating

contradiction to NSAID's

contraindication to regional anesthesia

have a pre-existing peripheral neuropathy involving the operative site

have an allergy to local anesthetics

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

North York General Hospital

Toronto, CanadaOpen North York General Hospital in Google Maps

CompletedOne Study Center