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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03198871
Other study ID # PRO17050418
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 24, 2018
Est. completion date November 30, 2020

Study information

Verified date January 2021
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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Study Design


Intervention

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
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.

Locations

Country Name City State
United States Upmc Presbyterian Montefiore Hospital Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Kathirvel Subramaniam Mallinckrodt

Country where clinical trial is conducted

United States, 

References & Publications (31)

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Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain Intensity 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. 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.
Secondary Total Post-operative Narcotic Consumption Rescue analgesia will be given according to institutional pain management protocol. Unit of Measure recorded as OME (Oral Morphine Equivalent) consumption in mg. From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first
Secondary Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU) The time from PACU admission to PACU discharge to the floor will be measured. From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively
Secondary Time to Bowel Movement The time it takes for the first bowel movement postoperatively will be measured. From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge
Secondary Time to Oral Intake The time it takes for the patient to ingest orally post-surgery will be measured. From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively
Secondary Time to Ambulation The time it takes for the patient to successfully ambulate post-surgery will be measured. From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively
Secondary Time to Hospital Discharge The time it takes for the patient to be fully discharged from the hospital post-surgery will be measured. From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first
Secondary Number of Participants With Readmission to the Hospital If the patient is readmitted to the hospital after being fully discharged, the event will be recorded. From the time of consent until 30 days post-operatively
Secondary Patient Satisfaction 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. These measurements will be taken at time of discharge up to 30 days, whichever comes first
Secondary Intensive Care Delirium Screening Checklist (ICDSC) 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. The delirium scores will first be measured every 12 hours for 72 hours after surgery.
Secondary Post-operative Nausea Nausea will be evaluated by nausea score from 0 to 10, with 0 equaling no nausea and 10 equaling the worst nausea imaginable. These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Secondary Post-operative Emesis Frequency of emesis and rescue antiemetic requirement will be documented These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Secondary SF-12 Health Survey 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 These measurements will take place at 30-days post hospital discharge
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