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IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population

Sponsor
Kathirvel Subramaniam (Other)
Overall Status
Completed
CT.gov ID
NCT03198871
Collaborator
Mallinckrodt (Industry)
180
Enrollment
1
Location
2
Arms
30.3
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Number of patients with unsatisfactory pain relief defined as average visual analog scale (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48 hours postoperative period will be compared between the two groups and form the primary outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with IV morphine equivalent doses of analgesics used to provide pain relief).

Condition or Disease Intervention/Treatment Phase
  • Drug: Acetaminophen Injectable Product
  • Drug: Sodium Chloride 0.9%, Intravenous
 Phase 4

Detailed Description

In response to an increased focus on improving patient outcomes and satisfaction with surgical care, a growing body of clinical evidence has recently been dedicated to enhanced recovery after surgery (ERAS) protocols. These evidence-based perioperative pathways aim to optimize patients undergoing surgery in the preoperative, intraoperative, and postoperative periods. ERAS protocols have incorporated the use of multimodal analgesia to minimize the use of intra- and postoperative opioid analgesics. Lidocaine, ketamine, magnesium, gabapentin, acetaminophen and non-steroidal anti-inflammatory drugs are some of the adjuvant analgesics used in combination with regional blocks to optimize analgesia and recovery. Multimodal analgesia has dependably been shown to significantly reduce postoperative opioid requirements as well as opioid-related side effects such as postoperative nausea and vomiting. Both oral and intravenous acetaminophen preparations have been shown to be useful adjuvants in multimodal analgesia. Intravenous acetaminophen has been of interest for its utility in post-surgical patients, who have not yet been cleared for oral intake. Intravenous acetaminophen should also be preferred over oral acetaminophen in patients after major abdominal surgery where absorption of medications given through oral route is erratic. Although the efficacy of intravenous acetaminophen as a postoperative pain adjunct is known, its exact role in ERAS protocols and non-narcotic multimodal analgesic regimens for major abdominal surgery has not been studied in randomized clinical trials to define its efficacy. The primary goal of this study is to assess the utility of a postoperative intravenous acetaminophen dosing schedule in minimizing postoperative pain, opioid consumption and opioid-related side effects. We also aim to study overall patient satisfaction and cost-effectiveness (direct and indirect costs) of this regimen as part of ERAS protocol at a large tertiary medical center.

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participant, care provider, outcomes assessor and investigator are all blinded to the treatment allocation
Primary Purpose:
Treatment
Official Title:
Role of Scheduled Intravenous Acetaminophen for Postoperative Pain Management in an Enhanced Recovery After Surgery (ERAS) Population: A Prospective, Randomized, Double-Blind and Placebo-Controlled Clinical Trial
Actual Study Start Date :
May 24, 2018
Actual Primary Completion Date :
Jul 7, 2019
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acetaminophen Injectable Product

Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group

Drug: Acetaminophen Injectable Product
The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
Other Names:
  • Tylenol
  • Paracetamol
  • Ofirmev

    		•
    Placebo Comparator: Sodium Chloride 0.9%, Intravenous

    Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group

    Drug: Sodium Chloride 0.9%, Intravenous
    The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative Pain Intensity [PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.]

      Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative.

    Secondary Outcome Measures

    1. Total Post-operative Narcotic Consumption [From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first]

      Rescue analgesia will be given according to institutional pain management protocol. Unit of Measure recorded as OME (Oral Morphine Equivalent) consumption in mg.

    2. Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU) [From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively]

      The time from PACU admission to PACU discharge to the floor will be measured.

    3. Time to Bowel Movement [From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge]

      The time it takes for the first bowel movement postoperatively will be measured.

    4. Time to Oral Intake [From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively]

      The time it takes for the patient to ingest orally post-surgery will be measured.

    5. Time to Ambulation [From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively]

      The time it takes for the patient to successfully ambulate post-surgery will be measured.

    6. Time to Hospital Discharge [From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first]

      The time it takes for the patient to be fully discharged from the hospital post-surgery will be measured.

    7. Number of Participants With Readmission to the Hospital [From the time of consent until 30 days post-operatively]

      If the patient is readmitted to the hospital after being fully discharged, the event will be recorded.

    8. Patient Satisfaction [These measurements will be taken at time of discharge up to 30 days, whichever comes first]

      Overall patient satisfaction as well as satisfaction relating to pain management and cost analyses will be measured. These will be measured with a numerical rating scale (NRS) with 0- being worst satisfaction and 10 - best satisfaction.

    9. Intensive Care Delirium Screening Checklist (ICDSC) [The delirium scores will first be measured every 12 hours for 72 hours after surgery.]

      Number of patients who score greater than a 4 on the 0-8 point ICDSC scale to assess delirium scores. 8 separate levels of signs for delirium assessed (1. altered level of consciousness, 2. inattention, 3. disorientation, 4. hallucination, delusion, or psychosis, 5. psychomotor agitation or retardation, 6. inappropriate speech or mood, 7. sleep-wake cycle disturbance, 8. symptom fluctuation), with 0 points awarded when patient does not exhibit above signs of delirium and 1 point awarded per confirmed sign of delirium. Score then totaled, 0 = normal, 1-3 = subsyndromal delirium, 4-8 = delirium.

    10. Post-operative Nausea [These will be evaluated from the time of PACU admission until 72 hours postoperatively.]

      Nausea will be evaluated by nausea score from 0 to 10, with 0 equaling no nausea and 10 equaling the worst nausea imaginable.

    11. Post-operative Emesis [These will be evaluated from the time of PACU admission until 72 hours postoperatively.]

      Frequency of emesis and rescue antiemetic requirement will be documented

    12. SF-12 Health Survey [These measurements will take place at 30-days post hospital discharge]

      Survey to assess patient's overall health (via a combination of mental and physical health assessment) at 30 days post-discharge. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Male or Female

    • 18 years of age or older

    • patients scheduled for elective colorectal, pancreatic, and other major abdominal procedure.

    • Patient consent will be obtained preoperatively for eligible study participants.

    Exclusion Criteria:

    • Patients who refuse to participate in the study or part of any other enhanced recovery after surgery (ERAS) research protocol.

    • Patients with a documented allergy to acetaminophen.

    • Chronic alcoholism

    • Hypovolemia

    • Chronic malnutrition

    • Preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis

    • Patients with a history of hepatic impairment, history of hepatic impairment or active hepatic disease

    • severe chronic pain condition that required daily preoperative opioid dependence

    • Patients with pre-existing dementia and/or other neuropsychiatric conditions impeding accurate assessment of pain scores or other study measures will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Upmc Presbyterian Montefiore Hospital Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • Kathirvel Subramaniam
    • Mallinckrodt

    Investigators

    • Principal Investigator: Kathirvel Subramaniam, M.D., M.P.H, Associate Professor and staff Anesthesiologist

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Kathirvel Subramaniam, Principal Investigator, Associate Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT03198871
    Other Study ID Numbers:
    • PRO17050418
    First Posted:
    Jun 26, 2017
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Kathirvel Subramaniam, Principal Investigator, Associate Professor, University of Pittsburgh
    Post-operative pain
    Major abdominal surgery
    Colorectal surgery
    Gastric surgery
    Additional relevant MeSH terms:
    Pancreatic Diseases
    Stomach Diseases
    Hernia, Abdominal
    Hernia, Ventral
    Internal Hernia
    Acetaminophen

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Period Title: Overall Study
    STARTED 90 90
    COMPLETED 76 78
    NOT COMPLETED 14 12

    Baseline Characteristics

    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous Total
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively. Total of all reporting groups
    Overall Participants 76 78 154
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    62
    64
    63
    Sex: Female, Male (Count of Participants)
    Female
    40
    52.6%
    44
    56.4%
    84
    54.5%
    Male
    36
    47.4%
    34
    43.6%
    70
    45.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    1
    1.3%
    1
    0.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    4
    5.3%
    2
    2.6%
    6
    3.9%
    White
    70
    92.1%
    73
    93.6%
    143
    92.9%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    2
    2.6%
    2
    2.6%
    4
    2.6%
    Region of Enrollment (participants) [Number]
    United States
    76
    100%
    78
    100%
    154
    100%
    Basal Metabolic Index (kg/m^2) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [kg/m^2]
    27.7
    28.25
    28.15
    Charlson Comorbidity Index (Count of Participants)
    0
    44
    57.9%
    41
    52.6%
    85
    55.2%
    1
    4
    5.3%
    10
    12.8%
    14
    9.1%
    2
    23
    30.3%
    24
    30.8%
    47
    30.5%
    >2
    5
    6.6%
    3
    3.8%
    8
    5.2%
    American Society of Anesthesiologists Classification (Count of Participants)
    II
    17
    22.4%
    18
    23.1%
    35
    22.7%
    III
    57
    75%
    55
    70.5%
    112
    72.7%
    IV
    2
    2.6%
    5
    6.4%
    7
    4.5%
    Number of participants taking medications for mental health (Count of Participants)
    Count of Participants [Participants]
    15
    19.7%
    27
    34.6%
    42
    27.3%
    Diabetes (Count of Participants)
    Count of Participants [Participants]
    4
    5.3%
    3
    3.8%
    7
    4.5%
    Hypertension (Count of Participants)
    Count of Participants [Participants]
    10
    13.2%
    16
    20.5%
    26
    16.9%
    Coronary artery disease (Count of Participants)
    Count of Participants [Participants]
    2
    2.6%
    4
    5.1%
    6
    3.9%
    Congestive failure (Count of Participants)
    Count of Participants [Participants]
    1
    1.3%
    3
    3.8%
    4
    2.6%
    Atrial fibrillation (Count of Participants)
    Count of Participants [Participants]
    2
    2.6%
    2
    2.6%
    4
    2.6%
    Pulmonary disease (Count of Participants)
    Count of Participants [Participants]
    3
    3.9%
    6
    7.7%
    9
    5.8%
    Malignancy (Count of Participants)
    Count of Participants [Participants]
    28
    36.8%
    23
    29.5%
    51
    33.1%
    Preoperative serum creatinine ((mg/dL)) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [(mg/dL)]
    0.8
    0.82
    0.81

    Outcome Measures

    1. Primary Outcome
    Title Postoperative Pain Intensity
    Description Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative.
    Time Frame PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Count of Participants [Participants]
    33
    43.4%
    42
    53.8%
    2. Secondary Outcome
    Title Total Post-operative Narcotic Consumption
    Description Rescue analgesia will be given according to institutional pain management protocol. Unit of Measure recorded as OME (Oral Morphine Equivalent) consumption in mg.
    Time Frame From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    0-24 hours
    27.4
    36
    24-48 hours
    31.3
    45
    48-72 hours
    30
    37.5
    0-48 hours
    74
    88.8
    0-72 hours
    105.00
    127.1
    3. Secondary Outcome
    Title Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU)
    Description The time from PACU admission to PACU discharge to the floor will be measured.
    Time Frame From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Median (Inter-Quartile Range) [minutes]
    129.00
    152.50
    4. Secondary Outcome
    Title Time to Bowel Movement
    Description The time it takes for the first bowel movement postoperatively will be measured.
    Time Frame From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Median (Inter-Quartile Range) [hours]
    46.30
    64.66
    5. Secondary Outcome
    Title Time to Oral Intake
    Description The time it takes for the patient to ingest orally post-surgery will be measured.
    Time Frame From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Median (Inter-Quartile Range) [hours]
    12.15
    9.40
    6. Secondary Outcome
    Title Time to Ambulation
    Description The time it takes for the patient to successfully ambulate post-surgery will be measured.
    Time Frame From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Median (Inter-Quartile Range) [hours]
    18.82
    17.38
    7. Secondary Outcome
    Title Time to Hospital Discharge
    Description The time it takes for the patient to be fully discharged from the hospital post-surgery will be measured.
    Time Frame From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Median (Inter-Quartile Range) [days]
    4.08
    4.94
    8. Secondary Outcome
    Title Number of Participants With Readmission to the Hospital
    Description If the patient is readmitted to the hospital after being fully discharged, the event will be recorded.
    Time Frame From the time of consent until 30 days post-operatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Count of Participants [Participants]
    9
    11.8%
    10
    12.8%
    9. Secondary Outcome
    Title Patient Satisfaction
    Description Overall patient satisfaction as well as satisfaction relating to pain management and cost analyses will be measured. These will be measured with a numerical rating scale (NRS) with 0- being worst satisfaction and 10 - best satisfaction.
    Time Frame These measurements will be taken at time of discharge up to 30 days, whichever comes first

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Patient satisfaction score, overall
    10
    10
    Patient Satisfaction score, pain management
    10
    10
    10. Secondary Outcome
    Title Intensive Care Delirium Screening Checklist (ICDSC)
    Description Number of patients who score greater than a 4 on the 0-8 point ICDSC scale to assess delirium scores. 8 separate levels of signs for delirium assessed (1. altered level of consciousness, 2. inattention, 3. disorientation, 4. hallucination, delusion, or psychosis, 5. psychomotor agitation or retardation, 6. inappropriate speech or mood, 7. sleep-wake cycle disturbance, 8. symptom fluctuation), with 0 points awarded when patient does not exhibit above signs of delirium and 1 point awarded per confirmed sign of delirium. Score then totaled, 0 = normal, 1-3 = subsyndromal delirium, 4-8 = delirium.
    Time Frame The delirium scores will first be measured every 12 hours for 72 hours after surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Count of Participants [Participants]
    0
    0%
    0
    0%
    11. Secondary Outcome
    Title Post-operative Nausea
    Description Nausea will be evaluated by nausea score from 0 to 10, with 0 equaling no nausea and 10 equaling the worst nausea imaginable.
    Time Frame These will be evaluated from the time of PACU admission until 72 hours postoperatively.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Nausea score POD 1 (am visit)
    1.13
    (2.82)
    0.60
    (1.76)
    Nausea score POD 1 (pm visit)
    0.49
    (1.54)
    0.92
    (2.53)
    Nausea score POD 2 (am visit)
    0.71
    (1.97)
    0.75
    (2.39)
    Nausea score POD 2 (pm visit)
    0.55
    (1.70)
    0.69
    (2.36)
    Nausea score POD 3 (am visit)
    0.32
    (1.37)
    0.66
    (2.18)
    Nausea score POD 3 (pm visit)
    0.56
    (1.77)
    0.78
    (2.42)
    12. Secondary Outcome
    Title Post-operative Emesis
    Description Frequency of emesis and rescue antiemetic requirement will be documented
    Time Frame These will be evaluated from the time of PACU admission until 72 hours postoperatively.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    Emesis incidence 0-72 hours
    12
    15.8%
    14
    17.9%
    Antiemetic use
    31
    40.8%
    45
    57.7%
    13. Secondary Outcome
    Title SF-12 Health Survey
    Description Survey to assess patient's overall health (via a combination of mental and physical health assessment) at 30 days post-discharge. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
    Time Frame These measurements will take place at 30-days post hospital discharge

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    Measure Participants 76 78
    SF 12 Physical score
    38.72
    38.07
    SF 12 Mental score
    54.02
    52.08

    Adverse Events

    Time Frame 30 Days
    Adverse Event Reporting Description
    Arm/Group Title Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Arm/Group Description Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
    All Cause Mortality
    Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/76 (0%) 0/78 (0%)
    Serious Adverse Events
    Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/76 (3.9%) 3/78 (3.8%)
    Renal and urinary disorders
    Acute Kidney Injury 2/76 (2.6%) 1/78 (1.3%)
    Respiratory, thoracic and mediastinal disorders
    Respiratory Depression 1/76 (1.3%) 1/78 (1.3%)
    Pnemonia 0/76 (0%) 1/78 (1.3%)
    Other (Not Including Serious) Adverse Events
    Acetaminophen Injectable Product Sodium Chloride 0.9%, Intravenous
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/76 (10.5%) 8/78 (10.3%)
    Gastrointestinal disorders
    Prolonged Ileus 1/76 (1.3%) 2/78 (2.6%)
    Renal and urinary disorders
    Urinary Retention 2/76 (2.6%) 3/78 (3.8%)
    Respiratory, thoracic and mediastinal disorders
    Respiratory Depression 1/76 (1.3%) 0/78 (0%)
    Skin and subcutaneous tissue disorders
    Pruritis 2/76 (2.6%) 0/78 (0%)
    Surgical and medical procedures
    Anastomotic Leak 2/76 (2.6%) 2/78 (2.6%)
    Pancreatic Leak 0/76 (0%) 1/78 (1.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Kathirvel Subramaniam MD MPH FASE
    Organization University of Pittsburgh School of Medicine / UPMC
    Phone 7247995852
    Email subramaniamk@upmc.edu
    Responsible Party:
    Kathirvel Subramaniam, Principal Investigator, Associate Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT03198871
    Other Study ID Numbers:
    • PRO17050418
    First Posted:
    Jun 26, 2017
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021