Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03770806
Status:
COMPLETED
Last Update Posted:
2018-12-10
First Post:
2017-05-15
Brief Title:
Factors Affecting the Speed of Recovery After ACL Reconstruction
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Factors Affecting the Speed of Recovery After Anterior Cruciate Ligament Reconstruction
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 subjects 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 questionnairesone that enquires about subjects 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
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 subjects 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 questionnairesone that enquires about subjects 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 patients ability to cooperate with rehabilitation maneuvers
Traditional methods of treatment for pain include use of opioid pain killers such as morphine andor 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 dependencyaddiction 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 andor 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 andor in combination with nerve blocks will determine the patients 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
Traditional methods of treatment for pain include use of opioid pain killers such as morphine andor 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 dependencyaddiction 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 andor 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 andor in combination with nerve blocks will determine the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None