Pain Outcomes After Anterior Cruciate Ligament Reconstruction With Posterior Capsular Marcaine Injection
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|ClinicalTrials.gov Identifier: NCT02826551|
Recruitment Status : Terminated (Not enough data.)
First Posted : July 11, 2016
Results First Posted : December 14, 2017
Last Update Posted : January 8, 2018
Post-operative pain control following elective anterior cruciate ligament reconstruction continues to be a hurdle for orthopaedic surgeons. This obstacle becomes particularly problematic during the first 36 hours after the operation, when the patient is experiencing pain at its peak intensity. Good control of pain leads to better patient comfort, confidence to place weight on the operative limb and improved ability to perform critical exercises in this period to improve joint range of motion.
A variety of anesthetic techniques have been employed to reduce pain including: cryotherapy, systemic analgesic and anti-inflammatory drugs, intrathecal, regional blockade of peripheral nerves and frequently intra-articular injections. Each technique has been studied at length with mixed but overall favorable results. However, in the authors' experience, after femoral nerve blockade, patients continue to complain of posterior knee pain in the Post-Anesthesia Care Unit (PACU) and peri-operative period. Intra-articular injections comprised of morphine and other Na-channel blocker analgesics may curb some of this pain by bathing the posterior capsule in anesthetic. However, there is still a large concern amongst orthopaedic surgeons about the potential harm these agents may have on the knee's healthy articular cartilage surfaces. The long term effects, including chondrolysis have been documented in the shoulder and while in the short term this effect is diminished there is still hesitation among surgeons to use this form of pain blockade.
This has led the investigators to adapt a technique of isolated posterior capsular injections after total knee replacements from the joint arthroplasty literature, which has shown favorable results with low complication risk. The investigators plan to study the effectiveness of this technique during ACL reconstruction in an attempt to curb the amount of posterior knee pain and decrease the overall narcotic use postoperatively while limiting the exposure of the native cartilage to harmful agents.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Drug: Marcaine Other: Ice Drug: Percocet Device: Knee Brace and Crutches||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pain Outcomes After Anterior Cruciate Ligament Reconstruction With Posterior Capsular Marcaine Injection: A Prospective Randomized Trial|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||May 10, 2017|
|Actual Study Completion Date :||May 10, 2017|
Placebo Comparator: No Injection
These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.
They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.
Device: Knee Brace and Crutches
These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.
They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.
Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.
Device: Knee Brace and Crutches
- VAS Scores [ Time Frame: Day 0-4 post-operatively ]VAS Scales recorded in AM and PM
- Pain Pill Count [ Time Frame: Day 0-4 post-operatively ]Patients will log the number of pills they take the first four days after surgery.