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

NCT00677261 | Completed DMC

• 1 other identifier: 378-2007
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty; Post Operative Analgesia

Keywords

Knee; Arthroplasty; Sciatic; Nerve; Block; Regional; Anesthesia; Infiltration; Local Anesthetic; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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).

  On arrival to PACU and every 4 hours thereafter.

Secondary Outcomes (1)

• The TUG (Timed up and go test) and Range of motion.

  Performed on day 2 and 3.

Study Arms (3)

1

EXPERIMENTAL

Procedure: Sciatic Nerve Block

2

EXPERIMENTAL

Procedure: Posterior capsule infiltration with local anesthetic

3

SHAM COMPARATOR

Procedure: Sham sciatic block and sham posterior infiltration

Interventions

Sciatic Nerve Block PROCEDURE

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.

1

Posterior capsule infiltration with local anesthetic PROCEDURE

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.

2

Sham sciatic block and sham posterior infiltration PROCEDURE

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.

3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status I and III
• Scheduled for total knee arthroplasty

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Holland Orthopedic and Arthritic Centre

Toronto, Ontario, M2N-3Y7, Canada

Location

MeSH Terms

Conditions

Bites and Stings; Agnosia

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Ben Safa, MD, FRCPC

  Staff Anesthesiologist, Sunnybrook Health Sciences Centre.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FRCPC Anesthesiologist

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 14, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 21, 2014

Record last verified: 2011-07

Locations

CA (1)