Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Virginia
About this trial
Postoperative pain is prevalent after intracranial surgery. Patients undergoing craniotomy are typically managed with short acting opioids to enable early and reliable post-operative neurological exam as well as avoid the risk of respiratory depression. However, a plethora of studies have shown that a majority of these patients experience moderate to severe pain in first 48 hours after surgery. Suboptimal pain control can lead to complications such as arterial hypertension and post-operative intracranial hemorrhage, and hence, increased morbidity and mortality.
Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery. Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery and received IV methadone intraoperatively.
In a recently published retrospective study, a single intraoperative dose of IV methadone was well tolerated with lower pain scores as well as MME (oral morphine milligram equivalents) requirements for up to 72 hours after elective intracranial surgery.
IV methadone has, however, never been compared with conventional management via IV remifentanil for functional recovery in patients undergoing elective intercranial surgery.
The investigator's hypothesis is that intravenous (IV) methadone is non-inferior to IV remifentanil in patients who undergo elective intracranial surgery. It offers the advantage of being a single dose noninvasive analgesic modality that may contribute to decreasing MME consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult Patients between ages 18 and 65 years old.
Undergoing supratentorial intracranial surgery
American Society of Anesthesiologists (ASA) physiological status I-III
Body Mass Index (BMI) between 18.5 and 45
Disqualifiers
Being unable or unwilling to sign a consent
Anticipated discharge within 24 hours after surgery
Patients requiring Emergent Surgery
Preoperative usage of Methadone, or allergy to it.
Trial design
Design model
Parallel
Treatments tested in this trial
Remifentanil
DrugIntravenous Remifentanil
Methadone
DrugIntravenous Methadone
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: IV RemifentanilActive comparator 1 intervention
Group B: IV MethadoneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quality of recovery after surgery on postoperative day 1,2,3 using QoR-15 psychometrical questionnaire (range 0-150).
The Quality of Recovery-15 (QoR-15) scale is a patient-reported outcome measurement of the quality of recovery after surgery and anesthesia. The scale ranges from 0 to 150, with a higher score indicating a better quality of recovery. A score of 0 indicates extremely poor quality of recovery, while a score of 150 indicates excellent quality of recovery. The QoR-15 score can be classified into four severity classes: excellent, good, moderate, and poor recovery.
Time frame
24 hours, 48 hours, 72 hoursSecondary outcomes
1
Morphine Milligram Equivalent
morphine milligram equivalent is a measurement of a given analgesic effect standardized to a milligram of morphine. In other words, agent X has the same effect as Y milligrams of morphine
Time frame
24 hours, 48 hours, 72 hours2
Numeric Rating scale (NRS) pain scores (0-10) as noted over post-operative day 0, 1, 2, and 3.
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Time frame
24 hours, 48 hours, 72 hours3
Overall Benefits of Analgesic Score (OBAS) as noted over post-operative day 0, 1, 2, and 3.
The overall benefit of analgesic score (OBAS) is a daily survey that assesses a patient's satisfaction with analgesia, pain intensity, and adverse effects. To compute score, add all scores in items 1-7. Range: \[0 - 28\]. A low score indicates high benefit.
Time frame
24 hours, 48 hours, 72 hours4
Complications and side effects as noted over post-operative day 0, 1, 2, and 3.
Complications and side-effects: (a) Ability to extubate patient in the operating room (yes or no) (i) If no, Documented Time to Extubation (b) Incidence of hypoxia (requiring \>2l NC O2 to maintain SpO2 \> 90), respiratory depression (RR\<8), and reintubation during the hospital stay after surgery (c) Time to ambulation, passing flatus, bowel movement (d) Incidence of pruritus, antiemetic medication administered - both as needed and scheduled (surrogate for PONV)
Time frame
24 hours, 48 hours, 72 hoursSponsors and contacts
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Source ClinicalTrials.gov