ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Outcomes After Anterior Cruciate Ligament Reconstruction With Posterior Capsular Marcaine Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02826551
Recruitment Status : Terminated (Not enough data.)
First Posted : July 11, 2016
Results First Posted : December 14, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Banffy, Cedars-Sinai Medical Center

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Other: Ice
Drug: Percocet
Device: Knee Brace and Crutches
Experimental: Injection

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.

Drug: Marcaine
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.

Other: Ice
Drug: Percocet
Device: Knee Brace and Crutches



Primary Outcome Measures :
  1. VAS Scores [ Time Frame: Day 0-4 post-operatively ]
    VAS Scales recorded in AM and PM


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult individuals (ages 18-60), both sexes, submitted to elective ACL reconstructions with or without partial menisectomies of the medial or lateral meniscus

Exclusion Criteria:

  • Multiligamentous injury or revision surgery
  • Known narcotic/substance abuse or regular opiate use
  • Known allergy to any medication or anesthetic being used in this study
  • Patients with pre-existing diabetic or femoral neropathy
  • INTRAOPERATIVELY- if chrondral microfractures, inside-out or outside-in meniscal repairs were performed (***Since these additional surgeries within the joint may increase the perceived level of pain post-op***)
  Study Documents (Full-Text)

Documents provided by Michael Banffy, Cedars-Sinai Medical Center:
Study Protocol  [PDF] July 1, 2015
Statistical Analysis Plan  [PDF] September 26, 2017


Publications:
Responsible Party: Michael Banffy, Attending - PI, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02826551     History of Changes
Other Study ID Numbers: Pro41651
First Posted: July 11, 2016    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: September 5, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents