IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population
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|ClinicalTrials.gov Identifier: NCT03198871|
Recruitment Status : Not yet recruiting
First Posted : June 26, 2017
Last Update Posted : April 24, 2018
|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)|
|Estimated Enrollment :||166 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|
|Estimated Study Start Date :||May 15, 2018|
|Estimated Primary Completion Date :||March 15, 2019|
|Estimated Study Completion Date :||August 15, 2019|
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
- 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 date of randomization until the date of first documented bowel movement, assessed up 72 hour postoperatively ]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.
- 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 even 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 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. ]The ICDSC will be used to assess delirium scores.
- 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 (0-10)
- 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 at 30 days post-discharge
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198871
|Contact: Amy Monroe||412-623-6382||Monroeal@upmc.edu|
|Contact: Caroline Kostishackemail@example.com|
|Principal Investigator:||Kathirvel Subramaniam, M.D., M.P.H||Associate Professor and staff Anesthesiologist|