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

NCT02826551 | Terminated Results

• 1 other identifier: Pro41651
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• VAS Scores

  VAS Scales recorded in AM and PM

  Day 0-4 post-operatively

Secondary Outcomes (1)

• Pain Pill Count

  Day 0-4 post-operatively

Study Arms (2)

No Injection

PLACEBO COMPARATOR

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

Injection

EXPERIMENTAL

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

Interventions

Marcaine DRUG

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.

Injection

Ice OTHER

Injection; No Injection

Percocet DRUG

Injection; No Injection

Knee Brace and Crutches DEVICE

Injection; No Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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\*\*\*)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Related Publications (1)

• Guild GN 3rd, Galindo RP, Marino J, Cushner FD, Scuderi GR. Periarticular regional analgesia in total knee arthroplasty: a review of the neuroanatomy and injection technique. Orthop Clin North Am. 2015 Jan;46(1):1-8. doi: 10.1016/j.ocl.2014.09.016.

  PMID: 25435030 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Ice; oxycodone-acetaminophen; Crutches

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Josh Page
• Organization: Cedars-Sinai

josh.page@cshs.org

3104233198

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending - PI

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: July 11, 2016
• Study Start: January 1, 2017
• Primary Completion: May 10, 2017
• Study Completion: May 10, 2017
• Last Updated: September 5, 2018
• Results First Posted: December 14, 2017

Record last verified: 2018-08