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
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|ClinicalTrials.gov Identifier: NCT00677261|
Recruitment Status : Completed
First Posted : May 14, 2008
Last Update Posted : November 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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.|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||November 2012|
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.
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.
- 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. ]
- The TUG (Timed up and go test) and Range of motion. [ Time Frame: Performed on day 2 and 3. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677261
|Holland Orthopedic and Arthritic Centre|
|Toronto, Ontario, Canada, M2N-3Y7|
|Principal Investigator:||Ben Safa, MD, FRCPC||Staff Anesthesiologist, Sunnybrook Health Sciences Centre.|