The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery
Condition: Pain
Study type: Interventional

Summary: 
      Seventy percent of surgeries performed in the United States are done in an outpatient
      setting.Pain Control after ambulatory surgery is very challenging because patients do not
      have access to fast and potent intravenous medications Pain after ambulatory surgery is
      poorly controlled in the United States with up to seventy five percent of patients having
      moderate to severe pain after ambulatory procedures. Postoperative pain have been associated
      with serious morbidity, including myocardial infarction and pulmonary embolism.

      The use of intraoperative opioids can result in an exaggerated response to pain
      (hyperalgesia) and contribute to an exacerbation of pain after surgical procedures.Opioids
      are commonly given intraoperative, not in response to pain, but in response to hyperdynamic
      cardiovascular states. Esmolol is a short acting beta 1 antagonist that can be used to
      treat/prevent hyperdynamic states during surgery. More importantly, esmolol has been shown to
      have central antihyperalgesic effects that might contribute to a reduction in postoperative
      pain. It is therefore conceivable that the use of intraoperative esmolol instead of opioids
      to avoid hyperdynamic states during surgery can result in lower postoperative pain. Since
      postoperative pain can substantially affect postoperative quality of recovery, it is also
      conceivable that the use of intraoperative esmolol might result in an improved postoperative
      quality of recovery to surgical patients.

      The main objective of the current study is to examine the effect of intraoperative esmolol on
      postoperative quality of recovery. A secondary objective is to examine the effect of esmolol
      on postoperative pain.

      Significance: Postoperative pain after ambulatory surgery has been shown to be poorly managed
      in The United States. The goal of this study is to investigate if a change in the
      intraoperative pharmacologic management of patients undergoing ambulatory surgery can improve
      their postoperative quality of recovery and pain.

      The research question is; does the use of intraoperative esmolol improve postoperative
      quality of recovery after ambulatory surgery? Does the use of intraoperative esmolol improve
      postoperative pain after ambulatory surgery?

      The hypotheses of this study is; does the use of intraoperative esmolol improves
      postoperative quality of recovery after ambulatory surgery. The use of intraoperative esmolol
      reduces postoperative pain after ambulatory surgery.
    

Detailed description: 
      We propose a randomized double blinded placebo controlled clinical trial. Healthy females
      undergoing outpatient surgery will be recruited . Before surgery patients will be tested for
      pain sensitivity and threshold using a Pathway Pain & sensory evaluation system (Medoc,
      Dunham, NC).Subjects will randomized using a computer generated table of random numbers to
      two groups: Active (Esmolol 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min titrated to
      keep heart rate between 50 and 70 BPM) or control (same volume of normal saline).The infusion
      will be discontinued at the end of the surgical procedure. Subjects will receive a standard
      anesthetic regimen: Induction (2 mg versed, 1-2mg /kg propofol and 0.6mg/kg of rocuronium),
      maintenance (Sevoflurane titrated to a Bispectral index between 40-60 and fentanyl 50 mcg q
      10 minutes to maintain blood pressure within 20% of baseline value. Patients will receive at
      the end of surgery ondansetron 4 mg IV to prevent nausea and/or vomiting. The postoperative
      analgesic regimen will also be standardized with hydromorphone 0.4 mg every 15 minutes to
      treat pain greater than 4/10 (scale where 0 means no pain and 10 means the worst possible
      pain) and hydrocodone 10 mg/acetaminophen 325 for pain control after discharge. Patients will
      receive ephedrine 5 mg q5minutes if blood pressure is lower than 40% baseline or if the heart
      rate is less than 40 beats per minute. Before hospital discharge patients will again be
      tested for pain sensitivity and threshold using a Pathway Pain & sensory evaluation system
      (Medoc, Dunham, NC).

      The primary outcome will be a validated instrument to measure postoperative quality of
      recovery (QoR-40) that will be administered to patients by an investigator unaware of group
      allocation at 24 hours after the surgery.Other outcomes to be evaluated include;
      postoperative pain sensitivity and threshold, postoperative opioid consumption, postoperative
      pain, time to meet discharge criteria using a validated instrument (PADDS).
    

Intervention name(s): Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min; Placebo Comparator: .9 normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min; Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Other intervention name(s): Esmolol; Normal Saline
Intervention MeSH terms: Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anesthesia; MEDOC neuro sensory analyzer; Pain; Quality of recovery