Comparing Postoperative Functional Recovery and Analgesic Efficacy of a Single Shot Sciatic Nerve Block Versus Posterior Capsule/Fat Pad Infiltration of Local Anesthetic for Total Knee Arthroplasty
19. november 2014 opdateret af: Dr. Ben Safa, Sunnybrook Health Sciences Centre
A Prospective, Unicenter, Randomized, Placebo Controlled, Clinical Interventional Trial, Comparing the Postoperative Functional Recovery as Well as Analgesic Efficacy of a Single Shot Sciatic Nerve Block Versus Posterior Capsule/Fat Pad Infiltration of Local Anesthetic for Total Knee Arthroplasty.
Many methods of pain relief have been implemented in an attempt to provide safe and effective analgesia for patients following total knee arthroplasty.
Numerous studies have demonstrated that nerve blocks can provide superior pain control and reduce side effects.
There are two major nerves that provide sensation to the knee: the femoral nerve provides sensation to the front of the knee and sciatic nerve provides sensation to the back of the knee.
Putting local anesthetic close to these nerves provides superior pain control.
The literature has supported the use of femoral nerve block for analgesia as well as improved functional outcome after total knee arthroplasty.
The purpose of this study is to see if the same is true for sciatic nerve block for the back of the knee.
We also would like to study an alternative approach to make the back of the knee pain free.
This involves injecting local anesthetic directly into this area at the end of your surgery.Patients will be randomized into 3 groups: sciatic block, posterior infiltration of local anesthetic and placebo.This study will help further define the role of sciatic nerve block as well as the alternative technique of local anesthetic infiltration in the perioperative analgesic regimen of total knee arthroplasty surgery, in an effort to develop a standardized perioperative protocol for this patient population.
The advent of this protocol should allow reduced risk, improved analgesia, and potentially earlier discharged from hospital with better function.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The objectives of this study are:
- Evaluate the role of sciatic nerve block in total knee replacement. There is conflicting data as to whether sciatic nerve block would provide significant analgesic benefit in addition to femoral nerve block and the usual multimodal and preemptive analgesic regimen for TKA.
- Investigate the efficacy of single-shot sciatic nerve block on early rehabilitation, functional recovery and patient satisfaction.
- Evaluate the previously described technique of local anesthetic infiltration into the posterior capsule/fat pad of the knee as an alternative technique to sciatic nerve block in providing analgesia to the posterior aspect of the knee in this select group of patients.
- Investigate the efficacy of local anesthetic infiltration into the posterior capsule/fat pad of the knee on early rehabilitation, functional recovery and patient satisfaction.
Study Design:
All patients will have a femoral nerve block (FNB) and spinal anesthesia.
Patients will be randomized into one of the 3 possible groups:
Group 1: Femoral nerve block + Sciatic nerve block + Spinal anesthesia + Infiltration of normal saline at the end of surgery
Group 2: Femoral nerve block + Sham Sciatic nerve block + Spinal anesthesia + Infiltration of local anesthetic at the end of surgery.
Group 3: Femoral nerve block + Sham Sciatic nerve block + Spinal anesthesia. + Infiltration of normal saline at the end of surgery.
In summary, this study will help further define the role of sciatic nerve block as well as the alternative technique of local anesthetic infiltration in the perioperative analgesic regimen of total knee arthroplasty surgery, in an effort to develop a standardized perioperative protocol for this patient population. The advent of this protocol should allow reduced risk, improved analgesia, and potentially earlier discharged from hospital with better function.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
104
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M2N-3Y7
- Holland Orthopedic and Arthritic Centre
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- American Society of Anesthesiologists physical status I and III
- Scheduled for total knee arthroplasty
Exclusion Criteria:
- Patients not providing informed consent.
- Refusal of treatment plan.
- Preexisting medical/neurological/hematologic conditions contraindicated for spinal anesthesia or peripheral nerve blocks.
- Revision total knee arthroplasty.
- Known allergy to any of the medications being used.
- History of drug or alcohol abuse.
- Patients with chronic pain on slow-release preparations of opioid in excess of 30mg of morphine equivalence per day.
- Patients with Rheumatoid Arthritis.
- Patients with psychiatric disorders.
- Patients unable or unwilling to use Patient Controlled Analgesia.
- Diabetic patients or those with impaired renal function (Creatinine >106).
- Obese patients (i.e. BMI >45).
- Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual rehabilitation protocol of care.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 1
|
Patients randomized to Group 1 will receive a single sciatic nerve block using the infragluteal parabiceps approach, using 20 ml of 0.5 % Ropivacaine.
A sham injection of the posterior capsule and fat pad using 50 cc of normal saline will be conducted at the conclusion of the surgery.
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Eksperimentel: 2
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Patients randomized to Group 2 will receive a Sham sciatic nerve block using 20cc of normal saline as described above as well as extensive local anesthetic infiltration of the posterior capsule and fat pad with a solution of 50 ml of 0.2% ropivicaine.
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Sham-komparator: 3
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Patients randomized to group 3 will only receive a continuous femoral nerve catheter, A sham sciatic nerve block with 20cc of normal saline as well as a sham injection of the posterior capsule and fat pad will be performed with 50cc of normal saline.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Visual Analog Scale (VAS) for pain will be used (0=no pain, 100mm = terrible pain) as our primary outcome, for 72 hours post-operatively (at rest and during mobilization).
Tidsramme: On arrival to PACU and every 4 hours thereafter.
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On arrival to PACU and every 4 hours thereafter.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The TUG (Timed up and go test) and Range of motion.
Tidsramme: Performed on day 2 and 3.
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Performed on day 2 and 3.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Ben Safa, MD, FRCPC, Staff Anesthesiologist, Sunnybrook Health Sciences Centre.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2008
Primær færdiggørelse (Faktiske)
1. september 2012
Studieafslutning (Faktiske)
1. november 2012
Datoer for studieregistrering
Først indsendt
12. maj 2008
Først indsendt, der opfyldte QC-kriterier
13. maj 2008
Først opslået (Skøn)
14. maj 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. november 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. november 2014
Sidst verificeret
1. juli 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 378-2007
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