IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population
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|ClinicalTrials.gov Identifier: NCT03198871|
Recruitment Status : Completed
First Posted : June 26, 2017
Results First Posted : January 28, 2021
Last Update Posted : January 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Wall Hernia Pancreatic Diseases Bowel Disease Gastric Disease||Drug: Acetaminophen Injectable Product Drug: Sodium Chloride 0.9%, Intravenous||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|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|
|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 :||July 7, 2019|
|Actual Study Completion Date :||November 30, 2020|
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
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 Name: Saline
- Postoperative Pain Intensity [ 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. ]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.
- Total Post-operative Narcotic Consumption [ Time Frame: 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.
- Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU) [ Time Frame: 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.
- Time to Bowel Movement [ Time Frame: 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.
- Time to Oral Intake [ Time Frame: 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.
- Time to Ambulation [ Time Frame: 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.
- Time to Hospital Discharge [ Time Frame: 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.
- Number of Participants With Readmission to the Hospital [ Time Frame: 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.
- Patient Satisfaction [ Time Frame: 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.
- Intensive Care Delirium Screening Checklist (ICDSC) [ Time Frame: 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.
- Post-operative Nausea [ Time Frame: 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.
- Post-operative Emesis [ Time Frame: These will be evaluated from the time of PACU admission until 72 hours postoperatively. ]Frequency of emesis and rescue antiemetic requirement will be documented
- SF-12 Health Survey [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198871
|United States, Pennsylvania|
|Upmc Presbyterian Montefiore Hospital|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Kathirvel Subramaniam, M.D., M.P.H||Associate Professor and staff Anesthesiologist|