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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00677261
First received: May 12, 2008
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Total Knee Arthroplasty
Post Operative Analgesia
Procedure: Sciatic Nerve Block
Procedure: Posterior capsule infiltration with local anesthetic
Procedure: Sham sciatic block and sham posterior infiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

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Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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). [ Time Frame: On arrival to PACU and every 4 hours thereafter. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The TUG (Timed up and go test) and Range of motion. [ Time Frame: Performed on day 2 and 3. ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: June 2008
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Sciatic Nerve Block
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.
Experimental: 2 Procedure: Posterior capsule infiltration with local anesthetic
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.
Sham Comparator: 3 Procedure: Sham sciatic block and sham posterior infiltration
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.

Detailed Description:

The objectives of this study are:

  1. 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.
  2. Investigate the efficacy of single-shot sciatic nerve block on early rehabilitation, functional recovery and patient satisfaction.
  3. 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.
  4. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00677261

Contacts
Contact: Ben Safa, M.D. 416 480 4864 ext 1715 ben.safa@sunnybrook.ca
Contact: Colin JL McCartney, M.D. 416 480 4864 colin.McCartney@sunnybrook.ca

Locations
Canada, Ontario
Holland Orthopedic and Arthritic Centre Recruiting
Toronto, Ontario, Canada, M2N-3Y7
Contact: Colin JL McCartney, MD, FRCPC    416 480 4864 ext 3230    Colin.McCartney@sunnybrook.ca   
Sub-Investigator: Colin JL McCartney, MD, FRCPC         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Ben Safa, MD, FRCPC Staff Anesthesiologist, Sunnybrook Health Sciences Centre.
  More Information

No publications provided

Responsible Party: Dr. Ben Safa, Sunnybrook Health Sciences Center
ClinicalTrials.gov Identifier: NCT00677261     History of Changes
Other Study ID Numbers: 378-2007
Study First Received: May 12, 2008
Last Updated: July 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Knee
Arthroplasty
Sciatic
Nerve
Block
Regional
Anesthesia
Infiltration
Local Anesthetic
Analgesia

Additional relevant MeSH terms:
Analgesics
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 22, 2014