Factors Affecting the Speed of Recovery After ACL Reconstruction
NCT ID: NCT03770806
Last Updated: 2018-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2017-03-24
2018-06-11
Brief Summary
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The investigators want to determine if standard methods of pain control after surgery affect future pain control, and the ability to exercise and recover muscle strength after surgery. The investigators are also interested in determining what other factors, such as age, gender, anxiety, or coping skills might be predictive of pain severity and speed of recovery. As part of the study, the investigators will record subject's ratings of pain severity, use of painkiller medicines, and muscle bulk measured by standardized tests, at various time intervals in the first 6 months after surgery. The investigators will also ask them to complete two questionnaires,one that enquires about subject's responses to pain in the past (catastrophizing test), and one that measures anxiety they might have about surgery or pain on the day of surgery. The investigators will be studying approximately 180 people who are having ACL repair at University of Washington. Subjects may be involved who are having multiple ligaments repaired including the anterior cruciate ligament
Detailed Description
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Traditional methods of treatment for pain include use of opioid pain killers (such as morphine) and/or femoral nerve block at the groin. The potential hazards of opioid pain killers include opioid side effects (nausea, vomiting, constipation, drowsiness, respiratory depression and the potential for developing opioid dependency=addiction). Pain in the early phase of recovery, if severe, can lead to changes in the spinal cord that predispose to amplifying pain sensations, thus intensifying the need for pain killer medicines, a process referred to as "windup" or neuroplasticity. Similarly, the use of opioid pain killers may activate pain amplification systems potentially contributing to persistence of pain and favoring development of chronic pain. For these reasons, there is a belief that early aggressive efforts to treat postoperative pain, and minimize the use of opioid pain killers, can have significant benefits to patients both by improving their comfort level after surgery; facilitating rehabilitation efforts and return to normal activity.
Anesthesiologists at the University of Washington may use pain medicines alone and/or perform a nerve block to help patients undergoing ACL repair with their pain control. Patients are given a choice as to their desired methods of pain control. These options are normally discussed by the regional block team with the patient prior to surgery and the merits of each discussed. Approximately 60-70% of patients typically request the use of nerve blocks in the recovery unit to help control their pain. For those patients who choose a nerve block, the anesthesiologist will choose to perform the nerve block at the level of the groin or the mid thigh. This decision varies by provider and is typically random in nature. Both locations for the nerve block appear to work most of the time and each may have small differences: the speed of onset is typically faster when performed at groin level, while quadriceps muscle function may be less affected when performed at mid thigh. Neither method is known to be superior for this type of surgery. Because patients are non-weight bearing for at least the first 24 hours after surgery and must use crutches for mobilization, the weakening of the quadriceps muscles may be relatively unimportant during that time.
The investigators hypothesize that pain treatment after ACL reconstruction which includes a nerve block in combination with other pain medications will be associated with better pain control immediately after surgery and will minimize the need for patients to use opioid pain killers and experience common opioid- related side effects. A secondary hypothesis is that the effectiveness of pain control, whether by pain medicines, and/or in combination with nerve blocks will determine the patient's ability to perform routine activities of daily living in the acute phase (0-7 days), and subsequently may affect their ability to perform physical therapy maneuvers that are prescribed for their routine care.
STUDY PURPOSE
Aim 1: Determine whether pain reported by patients after surgery is related to the type of pain control utilized - (1) either intravenous and oral pain medication alone, (2) combined with nerve block at the groin, or (3) combined with nerve block at the mid thigh.
Aim 2: Examine whether pain severity affects the ability of patients to perform activities of daily living in the acute phase (recovery index measured at 7 days), and physical therapy maneuvers in the ensuing 6 months after surgery possibly retarding restoration of muscle function in the affected leg.
Aim 3: Determine whether preoperative psychologic tests designed to assess patients' coping skills (Pain Catastrophizing score) and anxiety (Stait anxiety index) predict postoperative pain reported by patients, acute phase recovery scores (recovery index), and rehabilitation endpoints
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Femoral Nerve Block
Standard Ultrasound-guided femoral nerve block with Ropivacaine 0.5% and Dexamethasone 6-8mg. These subjects will also receive the standard multimodal oral premedication of Celebrex 300-400mg, Tylenol 1000mg, and Oxycontin 10mg.
Femoral Nerve Block
Standard Ultrasound-guided peri-neural femoral nerve block with Ropivacaine 0.5% and Dexamethasone 6-8mg.
Adductor Canal Nerve Block
Standard Ultrasound-guided adductor nerve block, mid-thigh, with Ropivacaine 0.5% and Dexamethasone 6-8mg. These subjects will also receive the standard multimodal oral premedication of Celebrex 300-400mg, Tylenol 1000mg, and Oxycontin 10mg.
Adductor Nerve Block
Standard Ultrasound-guided peri-neural adductor nerve block, mid-thigh, with Ropivacaine 0.5% and Dexamethasone 6-8mg
No Block
For subjects who choose to have medication alone with no block for their routine care, there will be no changes to their care, which includes receiving the multimodal oral premedication of Celebrex 300-400mg, Tylenol 1000mg, and Oxycontin 10mg. They will be in an observational group only with no randomization.
No Block
routine iv and oral pain medication alone-observation only
Interventions
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Femoral Nerve Block
Standard Ultrasound-guided peri-neural femoral nerve block with Ropivacaine 0.5% and Dexamethasone 6-8mg.
Adductor Nerve Block
Standard Ultrasound-guided peri-neural adductor nerve block, mid-thigh, with Ropivacaine 0.5% and Dexamethasone 6-8mg
No Block
routine iv and oral pain medication alone-observation only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must be undergoing ACL repair at UWMC
* Subjects must be between an anesthesia risk category of 1-3
* Subjects must be candidates to have a nerve block if they should choose so.
* Subjects must be free of neurologic disease or coagulation defects
* Subjects must have no allergies to typical medications used during nerve blocks.
* Subjects must be fluent in English, able to read, and understand English readily in person or and/over the phone.
Exclusion Criteria
* Patients with a BMI in excess of 40
* Non-English speaking patients
* Patients with allergies to nerve block medications
* Patients with neurological disease or coagulation defects
* Patients not undergoing ACL repair at UWMC
* Patients who are opioid tolerant
18 Years
75 Years
ALL
No
Sponsors
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University of Washington
OTHER
Responsible Party
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Vanessa Loland
Associate Professor, Anesthesiology and Pain Medicine
Locations
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University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.
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Luo TD, Ashraf A, Dahm DL, Stuart MJ, McIntosh AL. Femoral nerve block is associated with persistent strength deficits at 6 months after anterior cruciate ligament reconstruction in pediatric and adolescent patients. Am J Sports Med. 2015 Feb;43(2):331-6. doi: 10.1177/0363546514559823. Epub 2014 Dec 2.
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Other Identifiers
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51788
Identifier Type: -
Identifier Source: org_study_id