Factors Affecting the Speed of Recovery After ACL Reconstruction
Condition: Anterior Cruciate Ligament Injury; ACL Injury; ACL - Anterior Cruciate Ligament Rupture
MeSH terms: Wounds and Injuries; Rupture; Anterior Cruciate Ligament Injuries
Study type: Interventional

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 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
    

Intervention name(s): Femoral Nerve Block; Adductor Nerve Block; No Block
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Standard Ultrasound-guided peri-neural femoral nerve block with Ropivacaine 0.5% and Dexamethasone 6-8mg.; Standard Ultrasound-guided peri-neural adductor nerve block, mid-thigh, with Ropivacaine 0.5% and Dexamethasone 6-8mg; routine iv and oral pain medication alone-observation only
Other intervention name(s): Oral preoperative Celebrex(celecoxib) 300-400 mg; Oral preoperative acetaminophen 1000 mg; Oral preoperative oxycontin (Oxycodone HCl) 10 mg; Oral preoperative Celebrex(celecoxib) 300-400 mg; Oral preoperative acetaminophen 1000 mg; Oral preoperative oxycontin (Oxycodone HCl) 10 mg; Oral preoperative Celebrex(celecoxib) 300-400 mg; Oral preoperative acetaminophen 1000 mg; Oral preoperative oxycontin (Oxycodone HCl) 10 mg
Intervention MeSH terms: Acetaminophen; Celecoxib; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary purpose: Treatment