- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06701175
Knee Arthroscopy for Pain Control
Anterolateral Geniculate Nerve Block and Portal Anesthesia in Knee Arthroscopy for Pain Control: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Orthopaedic surgeries are some of the most painful operations to recover from, especially when involving cruciate ligaments. Because of this, orthopaedic surgeons have worked to optimize postoperative pain management that provides the best relief. Opioids traditionally were the primary medication for pain control during the perioperative period, however, with the current opioid epidemic and opioids being the leading cause of accidental deaths in the United States, physicians have transitioned to multimodal pain control which has shown to provide better pain control. In cases involving knee arthroscopy, pain management options include variations of nerve blocks, medications, surgical techniques, and postoperative activity.
An anterolateral genicular nerve block has been proposed that focuses on decreasing postoperative pain in the lateral aspect of the knee by targeting the lateral retinacular nerve, the nerve to the vastus lateralis, and the articular branch of the nerve to the vastus intermedius. Adductor canal blocks and intraarticular injections are known methods of providing postoperative pain control, but due to their risks, they may be inappropriate for knee arthroscopy. An anterolateral geniculate nerve block targets sensory, terminal nerve fibers outside the joint capsule, theoretically avoiding the risks of large nerve irritation and chondrotoxicity. Postoperative portal injections are another form of analgesia provided after knee arthroscopy and have been demonstrated to be equally effective in controlling pain as intraarticular injections one hour postoperatively. Otherwise, portal injections in knee arthroscopy have not been extensively studied in the literature.
Patients will be sent home after surgery with a survey to be completed at 2, 4, 6, 12, 24, and 48 hours and 1 week. The survey will inquire about the period from the prior survey to the current survey and will evaluate pain via Visual Analog Score, opioid consumption, non-opioid medication use, sleep, and intervention complications. Patients will be called at 12 and 48 hours and 1 week as reminders to complete the survey.
Study Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- skeletally mature patients with indications for knee arthroscopy
Exclusion Criteria:
- include patients with previous knee surgery on the operative side
- opioid use within six weeks before surgery that is deemed to be chronic or excessive
- gabapentin use within six weeks before surgery
- diagnosis of chronic pain, fibromyalgia, or other somatosensory disorder(s)
- history of radicular pain or neuropathy in the operative limb
- patients with cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Intervention
Patients will receive no intervention
|
|
|
Active Comparator: Nerve Block
Patients in the anterolateral geniculate nerve block group will receive 20 cc of 0.25% bupivacaine with epinephrine distributed evenly between two injection sites by an 18G or 21G long needle.
After completion of knee arthroscopy, the first injection is targeted at 2 fingerbreadths superior to the superolateral aspect of the patella.
The needle is inserted down to the femur, pulled back slightly, and the surrounding area is infiltrated with 10 cc of anesthetic.
The second injection is targeted approximately 2 to 3 fingerbreadths laterally to the first injection and 2 to 3 fingerbreadths proximal to the lateral epicondyle in line with the lateral femur.
Once again, the needle is inserted down until bone is encountered and then slightly retracted 1 to 2 mm before infiltration with the remaining 10 cc of anesthetic.
|
anterolateral geniculate nerve block
|
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Active Comparator: Portal Anesthesia
Patients in the portal anesthesia group will also receive 20 cc of 0.25% bupivacaine with epinephrine distributed evenly between portal sites.
After completion of knee arthroscopy, portal tracts are closed and the knee is ensured to be evacuated of residual fluid.
An 18G or 21G long needle is then used to infiltrate each portal tract where the anesthetic will be delivered.
|
portal anesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Management
Time Frame: 2, 4, 6, 12, 24, and 48 hours and 1 week post-op
|
Collected variables will include average and worst pain (0-10 scale, higher values representing increased pain), dose frequency of prescribed opioid analgesics, consumption of prescribed nonopioid analgesics, the longest period of uninterrupted sleep (in hours; only obtained at 12 and 24 hours and 1 week), and the subjective quality of sleep (0-10 scale, higher values representing better sleep), and overall satisfaction with pain control (five-point Likert scale, higher values representing increased satisfaction).
A Visual Analog Score will be used in the evaluation of pain.
|
2, 4, 6, 12, 24, and 48 hours and 1 week post-op
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Tyler TF, McHugh MP, Gleim GW, Nicholas SJ. The effect of immediate weightbearing after anterior cruciate ligament reconstruction. Clin Orthop Relat Res. 1998 Dec;(357):141-8. doi: 10.1097/00003086-199812000-00019.
- Townshend D, Emmerson K, Jones S, Partington P, Muller S. Intra-articular injection versus portal infiltration of 0.5% bupivacaine following arthroscopy of the knee: a prospective, randomised double-blinded trial. J Bone Joint Surg Br. 2009 May;91(5):601-3. doi: 10.1302/0301-620X.91B5.21932.
- Ghodki PS, Shalu PS, Sardesai SP. Ultrasound-guided adductor canal block versus femoral nerve block for arthroscopic anterior cruciate ligament repair under general anesthesia. J Anaesthesiol Clin Pharmacol. 2018 Apr-Jun;34(2):242-246. doi: 10.4103/joacp.JOACP_172_17.
- Howell R, Hill B, Hoffman C, Treacy E, Mulcahey MK. Peripheral Nerve Blocks for Surgery About the Knee. JBJS Rev. 2016 Dec 6;4(12):e1. doi: 10.2106/JBJS.RVW.16.00003.
- Chunduri A, Aggarwal AK. Multimodal Pain Management in Orthopedic Surgery. J Clin Med. 2022 Oct 28;11(21):6386. doi: 10.3390/jcm11216386.
- Paul RW, Szukics PF, Brutico J, Tjoumakaris FP, Freedman KB. Postoperative Multimodal Pain Management and Opioid Consumption in Arthroscopy Clinical Trials: A Systematic Review. Arthrosc Sports Med Rehabil. 2021 Dec 17;4(2):e721-e746. doi: 10.1016/j.asmr.2021.09.011. eCollection 2022 Apr.
- Meissner W, Mescha S, Rothaug J, Zwacka S, Goettermann A, Ulrich K, Schleppers A. Quality improvement in postoperative pain management: results from the QUIPS project. Dtsch Arztebl Int. 2008 Dec;105(50):865-70. doi: 10.3238/arztebl.2008.0865. Epub 2008 Dec 12.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300013299
- UAB (Other Identifier: UAB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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