Anterior Cruciate Ligament InjuryNCT03770806
Factors Affecting the Speed of Recovery After ACL Reconstruction
A study testing Femoral Nerve Block, Adductor Nerve Block and No Block in people with Anterior Cruciate Ligament Injury and ACL Injury, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to find out how postoperative pain affects recovery after anterior cruciate ligament (ACL) repair. Complete recovery after ACL repair involves healing of tissues at the surgical site, but also recovery of strength of the muscles that control movements at the knee. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, ACL Injury, ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- Femoral Nerve Block, Adductor Nerve Block and No Block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2017to 11 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be age 18-65,
- 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.
Who cannot join
- Any patients under 18 or over 75
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Factors Affecting the Speed of Recovery After Anterior Cruciate Ligament Reconstruction
The purpose of this study is to find out how postoperative pain affects recovery after anterior cruciate ligament (ACL) repair. Complete recovery after ACL repair involves healing of tissues at the surgical site, but also recovery of strength of the muscles that control movements at the knee. Some pain is normally experienced after ACL repair; the severity is variable from one individual to another. Pain is usually controlled by intravenous and oral (by mouth) pain medicines. It is also frequently controlled by numbing nerves that supply sensation to the knee joint and surrounding tissues. This procedure is called a nerve block.
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
Read the detailed description
Anterior cruciate ligament (ACL) tears of the knee are frequently repaired by surgically implanting a tendon graft in place of the torn original cruciate ligament. The graft may be taken from the patient having the repair (an autologous graft) or from a cadaver (an allograft). Complete recovery from surgical repair of an anterior cruciate ligament reconstruction requires that the graft becomes firmly engrafted at the site, surrounding tissues are healed and strength is restored in muscles that control movements at the knee. The recovery process typically requires from six months to one year. Pain in the early phase of recovery is typically moderate to severe and may be a major factor determining patient return to normal activity. It may also be a major factor limiting the patient's ability to cooperate with rehabilitation maneuvers.
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
- Being tested
- Femoral Nerve Block, Adductor Nerve Block, No Block
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nerve BlockProcedure or surgery
Also called Oral preoperative Celebrex(celecoxib) 300-400 mg, Oral preoperative acetaminophen 1000 mg, Oral preoperative oxycontin (Oxycodone HCl) 10 mg
Standard Ultrasound-guided peri-neural femoral nerve block with Ropivacaine 0.5% and Dexamethasone 6-8mg.
Adductor Nerve BlockProcedure or surgery
Also called Oral preoperative Celebrex(celecoxib) 300-400 mg, Oral preoperative acetaminophen 1000 mg, Oral preoperative oxycontin (Oxycodone HCl) 10 mg
Standard Ultrasound-guided peri-neural adductor nerve block, mid-thigh, with Ropivacaine 0.5% and Dexamethasone 6-8mg
No BlockOther
Also called Oral preoperative Celebrex(celecoxib) 300-400 mg, Oral preoperative acetaminophen 1000 mg, Oral preoperative oxycontin (Oxycodone HCl) 10 mg
routine iv and oral pain medication alone-observation only
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Block | Experimental | 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. Receives: Procedure: Femoral Nerve Block |
| Adductor Canal Nerve Block | Experimental | 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. Receives: Procedure: Adductor Nerve Block |
| No Block | Experimental | 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. Receives: Other: No Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: 30 minutes after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: while walking 24 hours after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: While walking 48 hours after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: While walking 7 days after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: While walking 2 weeks after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: While walking 4 weeks after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: While walking 2 months after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: While walking 3 months after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: While walking 4 months after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: While walking 5 months after block treatment
Verbal Pain Scores
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Measured: While walking 6 months after block treatment
Secondary outcomes (24)
Pain Catastrophizing Score
The pain catastrophizing score " is a self-rating scale designed to measure the extent to which subjects have certain thoughts and feelings when they have experienced painful situations in the past . The goal is to identify the extent to which subjects magnify the effects of pain, ruminate about pain, or feel helpless in the face of pain, collectively described as "catastrophizing".. It consists of 13 questions rated 0- 4 in response to the Prefix "When I'm in Pain, I worry….. with 0 being not at all, and 4 being all the time. The maximum total score is 52 Maximum score of 52 would indicate severe catastrophizing tendency, and 0 none. The results of 3 subscales are summed (magnification , rumination and helplessness ) for the final score.where 0= not a catastrophizer, and 52 would be the greatest level of catastrophizing about pain
Measured: Pre-Operative measure-performed in preoperative holding area immediately before surgery
Abbreviated State Anxiety Score
This scale is designed to assesses patients' state of anxiety preoperatively on the day of surgery.. A questionnaire that is a validated short form of the State-Trait anxiety test is used .
It consists of 6 questions relating to the patient's current state of anxiety. It is administered in the preoperative holding area before the subjects have they receive any medication. They are asked how they feel on a scale of 1-4 with 1-being not at all, and 4 being very much so, in response to being asked if they feel Calm, tense, upset, relaxed, content or worried. The scores for positive (non- anxious) emotions are reversed numerically to convert high numbers to low numbers, and the anxious responses remain positive with the highest numbers (4) indicating the highest level of anxiety. The results of the converted 6 components are then summed.
The maximum anxiety score is 24 = very anxious; the minimum is 0 = not anxious at all
Measured: Pre-Operative Measure-performed in preopertive holding area immediately before surgery
Physical Therapy milestones-duration of activity
Minutes of rehab exercises/week time spent doing physical therapy exercises/week
Measured: At physical therapy appointment 4 weeks after block treatment
Physical Therapy milestones-mobility
Degrees of knee flexion and extension, thigh circumference in each leg
Measured: At physical therapy appointment 4 weeks after block treatment
Physical Therapy milestones-duration of activity
Minutes of rehab exercises/week
Measured: At physical therapy appointment 2 months after block treatment
Physical Therapy milestones-mobility
Degrees of knee flexion and extension, thigh circumference in each leg
Measured: At physical therapy appointment 2 months after block treatment
Physical Therapy milestones-duration of activity
Minutes of rehab exercises/week
Measured: At physical therapy appointment 3 months after block treatment
Physical Therapy milestones-mobility
Degrees of knee flexion and extension, thigh circumference in each leg
Measured: At physical therapy appointment 3 months after block treatment
Physical Therapy milestones-duration of activity
Minutes of rehab exercises/week
Measured: At physical therapy appointment 4 months after block treatment
Physical Therapy milestones-mobility
Degrees of knee flexion and extension, thigh circumference in each leg
Measured: At physical therapy appointment 4 months after block treatment
Physical Therapy milestones-duration of activity
Minutes of rehab exercises/week
Measured: At physical therapy appointment 5 months after block treatment
Physical Therapy milestones-mobility
Degrees of knee flexion and extension, thigh circumference in each leg
Measured: At physical therapy appointment 5 months after block treatment
Physical Therapy milestones-duration of activity
Minutes of rehab exercises/week
Measured: At physical therapy appointment 6 months after block treatment
Physical Therapy milestones-mobility
Degrees of knee flexion and extension, thigh circumference in each leg
Measured: At physical therapy appointment 6 months after block treatment
Self-reported Verbal Pain scores correlational analysis
correlate verbal pain scores with opioid use at 0-24 hrs (Spearmans correlation coefficient)
Measured: 24 hours after block treatment
Self-reported Verbal Pain scores correlational analysis
correlate verbal pain scores with opioid use at 24-48hrs (Spearman'scorrelation coefficient)
Measured: 48 hours after block treatment
Self-reported Verbal Pain scores correlational analysis
Correlate recovery index with verbal pain scores (Pearson, and spearman's r)
Measured: 7 days after block treatment
Self-reported Verbal Pain scores correlational analysis
correlate verbal pain scores with knee flexion and extension, and duration of exercise (Spearman's r)
Measured: 2 weeks after block treatment
Self-reported Verbal Pain scores correlational analysis
correlate verbal pain scores with knee flexion and extension, and duration of exercise (Spearman's r)
Measured: 4 weeks after block treatment
Self-reported Verbal Pain scores correlational analysis
correlate verbal pain scores with knee flexion and extension and duration of exercise (Spearman's r)
Measured: 2 months after block treatment
Self-reported Verbal Pain scores
correlate verbal pain scores with knee flexion and extension and duration of exercise (Spearman's r)
Measured: 3 months after block treatment
Self-reported Verbal Pain scores
correlate verbal pain scores with knee flexion and extension and duration of exercise (Spearman's r)
Measured: 4 months after block treatment
Self-reported Verbal Pain scores
correlate verbal pain scores with knee flexion and extension and duration of exercise (Spearman's r)
Measured: 5 months after block treatment
Self-reported Verbal Pain scores
correlate verbal pain scores with knee flexion and extension and duration of exercise (Spearman's r)
Measured: 6 months after block treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start24 Mar 2017
- Primary completion11 Jun 2018
- Study completion11 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects who choose to have medication alone with no block for their routine care will be in an observational group only with no randomization. Subjects who elect to have a nerve block placed for their routine treatment will be randomized per the research protocol to have the block placed at either the groin or the mid-thigh. Subjects in each study group will perform the same study procedures. This study will follow subjects for the first 6 months of their recovery to observe routine care pain treatments and evaluate whether the methods of pain control determine (a) severity and duration of postoperative pain, (b) the speed of recovery of muscle function, and (c) pain responses and aggressiveness of pursuing physical therapy maneuvers
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Loland, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770806
- Sponsor's protocol ID
- 51788
- Status last verified
- Dec 2018
- First submitted
- 15 May 2017
- Last updated
- 10 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23811426Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: a meta-analysis. Anesth Analg. 2005 Mar;100(3):757-773. doi: 10.1213/01.ANE.0000144428.98767.0E.
PubMed 15728066Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.
PubMed 25376972Sawyer S. Femoral nerve block for pain relief after total knee replacement. Prof Nurse. 2004 Feb;19(6):333-7.
PubMed 14983606Johnson RL, Duncan CM, Ahn KS, Schroeder DR, Horlocker TT, Kopp SL. Fall-prevention strategies and patient characteristics that impact fall rates after total knee arthroplasty. Anesth Analg. 2014 Nov;119(5):1113-8. doi: 10.1213/ANE.0000000000000438.
PubMed 25211392Hanson NA, Allen CJ, Hostetter LS, Nagy R, Derby RE, Slee AE, Arslan A, Auyong DB. Continuous ultrasound-guided adductor canal block for total knee arthroplasty: a randomized, double-blind trial. Anesth Analg. 2014 Jun;118(6):1370-7. doi: 10.1213/ANE.0000000000000197.
PubMed 24842182Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27. doi: 10.1097/00000542-200602000-00018.
PubMed 16436852Ilfeld BM, Meyer RS, Le LT, Mariano ER, Williams BA, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Maldonado RC, Gearen PF. Health-related quality of life after tricompartment knee arthroplasty with and without an extended-duration continuous femoral nerve block: a prospective, 1-year follow-up of a randomized, triple-masked, placebo-controlled study. Anesth Analg. 2009 Apr;108(4):1320-5. doi: 10.1213/ane.0b013e3181964937.
PubMed 19299806Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.
PubMed 23788068Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
PubMed 23241723Pavlin DJ, Sullivan MJ, Freund PR, Roesen K. Catastrophizing: a risk factor for postsurgical pain. Clin J Pain. 2005 Jan-Feb;21(1):83-90. doi: 10.1097/00002508-200501000-00010.
PubMed 15599135Hart DL, Werneke MW, George SZ, Matheson JW, Wang YC, Cook KF, Mioduski JE, Choi SW. Screening for elevated levels of fear-avoidance beliefs regarding work or physical activities in people receiving outpatient therapy. Phys Ther. 2009 Aug;89(8):770-85. doi: 10.2522/ptj.20080227. Epub 2009 Jun 18.
PubMed 19541772Asmundson GJ, Bovell CV, Carleton RN, McWilliams LA. The Fear of Pain Questionnaire-Short Form (FPQ-SF): factorial validity and psychometric properties. Pain. 2008 Jan;134(1-2):51-8. doi: 10.1016/j.pain.2007.03.033. Epub 2007 May 4.
PubMed 17482361Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
PubMed 1393159Csintalan RP, Inacio MC, Funahashi TT. Incidence rate of anterior cruciate ligament reconstructions. Perm J. 2008 Summer;12(3):17-21. doi: 10.7812/TPP/07-140.
PubMed 21331205
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Speed of Recovery After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT03770806
- Acronym / sponsor ID
- 51788
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out how postoperative pain affects recovery after anterior cruciate ligament (ACL) repair. Complete recovery after ACL repair involves healing of tissues at the surgical site, but also recovery of strength of the muscles that control movements at the knee. Some pain is normally experienced after ACL repair; the severity is variable from one individual to another. Pain is usually controlled by intravenous and oral (by mouth) pain medicines. It is also frequently controlled by numbing nerves that supply sensation to the knee joint and surrounding tissues. This procedure is called a nerve block.
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
Anterior cruciate ligament (ACL) tears of the knee are frequently repaired by surgically implanting a tendon graft in place of the torn original cruciate ligament. The graft may be taken from the patient having the repair (an autologous graft) or from a cadaver (an allograft). Complete recovery from surgical repair of an anterior cruciate ligament reconstruction requires that the graft becomes firmly engrafted at the site, surrounding tissues are healed and strength is restored in muscles that control movements at the knee. The recovery process typically requires from six months to one year. Pain in the early phase of recovery is typically moderate to severe and may be a major factor determining patient return to normal activity. It may also be a major factor limiting the patient's ability to cooperate with rehabilitation maneuvers.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects who choose to have medication alone with no block for their routine care will be in an observational group only with no randomization. Subjects who elect to have a nerve block placed for their routine treatment will be randomized per the research protocol to have the block placed at either the groin or the mid-thigh. Subjects in each study group will perform the same study procedures. This study will follow subjects for the first 6 months of their recovery to observe routine care pain treatments and evaluate whether the methods of pain control determine (a) severity and duration of postoperative pain, (b) the speed of recovery of muscle function, and (c) pain responses and aggressiveness of pursuing physical therapy maneuvers
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Block | Experimental | Procedure: Femoral Nerve BlockStandard 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. |
| Adductor Canal Nerve Block | Experimental | Procedure: Adductor Nerve BlockStandard 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. |
| No Block | Experimental | Other: No BlockFor 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be age 18-65,
- 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
Key exclusion criteria (7 listed)
- Any patients under 18 or over 75
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral Nerve BlockAlso: Oral preoperative Celebrex(celecoxib) 300-400 mg, Oral preoperative acetaminophen 1000 mg, Oral preoperative oxycontin (Oxycodone HCl) 10 mgStandard Ultrasound-guided peri-neural femoral nerve block with Ropivacaine 0.5% and Dexamethasone 6-8mg. | Procedure or surgery | Femoral Nerve Block |
| Adductor Nerve BlockAlso: Oral preoperative Celebrex(celecoxib) 300-400 mg, Oral preoperative acetaminophen 1000 mg, Oral preoperative oxycontin (Oxycodone HCl) 10 mgStandard Ultrasound-guided peri-neural adductor nerve block, mid-thigh, with Ropivacaine 0.5% and Dexamethasone 6-8mg | Procedure or surgery | Adductor Canal Nerve Block |
| No BlockAlso: Oral preoperative Celebrex(celecoxib) 300-400 mg, Oral preoperative acetaminophen 1000 mg, Oral preoperative oxycontin (Oxycodone HCl) 10 mgroutine iv and oral pain medication alone-observation only | Other | No Block |
Primary outcome
Verbal Pain Scores
Time frame: 30 minutes after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: while walking 24 hours after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: While walking 48 hours after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: While walking 7 days after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: While walking 2 weeks after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: While walking 4 weeks after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: While walking 2 months after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: While walking 3 months after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: While walking 4 months after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: While walking 5 months after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
Verbal Pain Scores
Time frame: While walking 6 months after block treatment
self- reported verbal pain score where 0= no pain and 10 = worst imaginable
24 secondary outcomes
Pain Catastrophizing Score
Time frame: Pre-Operative measure-performed in preoperative holding area immediately before surgery
Abbreviated State Anxiety Score
Time frame: Pre-Operative Measure-performed in preopertive holding area immediately before surgery
Physical Therapy milestones-duration of activity
Time frame: At physical therapy appointment 4 weeks after block treatment
Physical Therapy milestones-mobility
Time frame: At physical therapy appointment 4 weeks after block treatment
Physical Therapy milestones-duration of activity
Time frame: At physical therapy appointment 2 months after block treatment
Physical Therapy milestones-mobility
Time frame: At physical therapy appointment 2 months after block treatment
Physical Therapy milestones-duration of activity
Time frame: At physical therapy appointment 3 months after block treatment
Physical Therapy milestones-mobility
Time frame: At physical therapy appointment 3 months after block treatment
Physical Therapy milestones-duration of activity
Time frame: At physical therapy appointment 4 months after block treatment
Physical Therapy milestones-mobility
Time frame: At physical therapy appointment 4 months after block treatment
Physical Therapy milestones-duration of activity
Time frame: At physical therapy appointment 5 months after block treatment
Physical Therapy milestones-mobility
Time frame: At physical therapy appointment 5 months after block treatment
Physical Therapy milestones-duration of activity
Time frame: At physical therapy appointment 6 months after block treatment
Physical Therapy milestones-mobility
Time frame: At physical therapy appointment 6 months after block treatment
Self-reported Verbal Pain scores correlational analysis
Time frame: 24 hours after block treatment
Self-reported Verbal Pain scores correlational analysis
Time frame: 48 hours after block treatment
Self-reported Verbal Pain scores correlational analysis
Time frame: 7 days after block treatment
Self-reported Verbal Pain scores correlational analysis
Time frame: 2 weeks after block treatment
Self-reported Verbal Pain scores correlational analysis
Time frame: 4 weeks after block treatment
Self-reported Verbal Pain scores correlational analysis
Time frame: 2 months after block treatment
Self-reported Verbal Pain scores
Time frame: 3 months after block treatment
Self-reported Verbal Pain scores
Time frame: 4 months after block treatment
Self-reported Verbal Pain scores
Time frame: 5 months after block treatment
Self-reported Verbal Pain scores
Time frame: 6 months after block treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Background: PubMed 23811426Andreae 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.
- Background: PubMed 15728066Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: a meta-analysis. Anesth Analg. 2005 Mar;100(3):757-773. doi: 10.1213/01.ANE.0000144428.98767.0E.
- Background: PubMed 25376972Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.
- Background: PubMed 14983606Sawyer S. Femoral nerve block for pain relief after total knee replacement. Prof Nurse. 2004 Feb;19(6):333-7.
- Background: PubMed 25211392Johnson RL, Duncan CM, Ahn KS, Schroeder DR, Horlocker TT, Kopp SL. Fall-prevention strategies and patient characteristics that impact fall rates after total knee arthroplasty. Anesth Analg. 2014 Nov;119(5):1113-8. doi: 10.1213/ANE.0000000000000438.
- Background: PubMed 24842182Hanson NA, Allen CJ, Hostetter LS, Nagy R, Derby RE, Slee AE, Arslan A, Auyong DB. Continuous ultrasound-guided adductor canal block for total knee arthroplasty: a randomized, double-blind trial. Anesth Analg. 2014 Jun;118(6):1370-7. doi: 10.1213/ANE.0000000000000197.
- Background: PubMed 16436852Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27. doi: 10.1097/00000542-200602000-00018.
- Background: PubMed 19299806Ilfeld BM, Meyer RS, Le LT, Mariano ER, Williams BA, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Maldonado RC, Gearen PF. Health-related quality of life after tricompartment knee arthroplasty with and without an extended-duration continuous femoral nerve block: a prospective, 1-year follow-up of a randomized, triple-masked, placebo-controlled study. Anesth Analg. 2009 Apr;108(4):1320-5. doi: 10.1213/ane.0b013e3181964937.
- Background: PubMed 23788068Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.
- Background: PubMed 23241723Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
- Background: PubMed 15599135Pavlin DJ, Sullivan MJ, Freund PR, Roesen K. Catastrophizing: a risk factor for postsurgical pain. Clin J Pain. 2005 Jan-Feb;21(1):83-90. doi: 10.1097/00002508-200501000-00010.
- Background: PubMed 19541772Hart DL, Werneke MW, George SZ, Matheson JW, Wang YC, Cook KF, Mioduski JE, Choi SW. Screening for elevated levels of fear-avoidance beliefs regarding work or physical activities in people receiving outpatient therapy. Phys Ther. 2009 Aug;89(8):770-85. doi: 10.2522/ptj.20080227. Epub 2009 Jun 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Nerve Block, Adductor Nerve Block and No Block in people with Anterior Cruciate Ligament Injury and ACL Injury, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Pain Scores (time frame: 30 minutes after block treatment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03770806, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.