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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen Injectable Product | Experimental | Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group |
|
| Sodium Chloride 0.9%, Intravenous | Placebo Comparator | Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen Injectable Product | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathirvel Subramaniam, M.D., M.P.H | Associate Professor and staff Anesthesiologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Upmc Presbyterian Montefiore Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23499469 | Background | Ziemann-Gimmel P, Hensel P, Koppman J, Marema R. Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):975-80. doi: 10.1016/j.soard.2013.02.003. Epub 2013 Feb 13. | |
| 24554545 | Background | Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen Injectable Product | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2019 |
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Participant, care provider, outcomes assessor and investigator are all blinded to the treatment allocation
|
| Sodium Chloride 0.9%, Intravenous | Drug | The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively. |
|
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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 |
| 7717542 | Background | Practice guidelines for acute pain management in the perioperative setting. A report by the American Society of Anesthesiologists Task Force on Pain Management, Acute Pain Section. Anesthesiology. 1995 Apr;82(4):1071-81. No abstract available. |
| 27562836 | Background | Hansen RN, Pham A, Strassels SA, Balaban S, Wan GJ. Erratum to: Comparative Analysis of Length of Stay and Inpatient Costs for Orthopedic Surgery Patients Treated with IV Acetaminophen and IV Opioids vs. IV Opioids Alone for Post-Operative Pain. Adv Ther. 2016 Sep;33(9):1646-1648. doi: 10.1007/s12325-016-0400-z. No abstract available. |
| 26328237 | Background | Bollinger AJ, Butler PD, Nies MS, Sietsema DL, Jones CB, Endres TJ. Is Scheduled Intravenous Acetaminophen Effective in the Pain Management Protocol of Geriatric Hip Fractures? Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):202-8. doi: 10.1177/2151458515588560. |
| 25521844 | Background | Herring BO, Ader S, Maldonado A, Hawkins C, Kearson M, Camejo M. Impact of intravenous acetaminophen on reducing opioid use after hysterectomy. Pharmacotherapy. 2014 Dec;34 Suppl 1:27S-33S. doi: 10.1002/phar.1513. |
| 20220746 | Background | Jokela R, Ahonen J, Seitsonen E, Marjakangas P, Korttila K. The influence of ondansetron on the analgesic effect of acetaminophen after laparoscopic hysterectomy. Clin Pharmacol Ther. 2010 Jun;87(6):672-8. doi: 10.1038/clpt.2009.281. Epub 2010 Mar 10. |
| Background | Gonzalez A, Ziemann-Gimmel P. The role of multimodal analgesia in bariatric surgery: A review of clinical data and case-based presentations featuring OFIRMEV® (acetaminophen) injection. Surgical Pain Management. 2014;11(5): A2-11. |
| 16130055 | Background | Pettersson PH, Jakobsson J, Owall A. Intravenous acetaminophen reduced the use of opioids compared with oral administration after coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 2005 Jun;19(3):306-9. doi: 10.1053/j.jvca.2005.03.006. |
| 27236864 | Background | Mamoun NF, Lin P, Zimmerman NM, Mascha EJ, Mick SL, Insler SR, Sessler DI, Duncan AE. Intravenous acetaminophen analgesia after cardiac surgery: A randomized, blinded, controlled superiority trial. J Thorac Cardiovasc Surg. 2016 Sep;152(3):881-889.e1. doi: 10.1016/j.jtcvs.2016.04.078. Epub 2016 May 5. |
| 27498260 | Background | Douzjian DJ, Kulik A. Old Drug, New Route: A Systematic Review of Intravenous Acetaminophen After Adult Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):694-701. doi: 10.1053/j.jvca.2016.03.134. Epub 2016 Mar 16. No abstract available. |
| 25797725 | Background | Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, McMurry TL, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of care: impact of an enhanced recovery protocol on length of stay, complications, and direct costs after colorectal surgery. J Am Coll Surg. 2015 Apr;220(4):430-43. doi: 10.1016/j.jamcollsurg.2014.12.042. Epub 2015 Jan 9. |
| 26469366 | Background | Doleman B, Read D, Lund JN, Williams JP. Preventive Acetaminophen Reduces Postoperative Opioid Consumption, Vomiting, and Pain Scores After Surgery: Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):706-12. doi: 10.1097/AAP.0000000000000311. |
| 15681586 | Background | Remy C, Marret E, Bonnet F. Effects of acetaminophen on morphine side-effects and consumption after major surgery: meta-analysis of randomized controlled trials. Br J Anaesth. 2005 Apr;94(4):505-13. doi: 10.1093/bja/aei085. Epub 2005 Jan 28. |
| 21114616 | Background | Macario A, Royal MA. A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain Pract. 2011 May-Jun;11(3):290-6. doi: 10.1111/j.1533-2500.2010.00426.x. Epub 2010 Nov 28. |
| 18580346 | Background | Cakan T, Inan N, Culhaoglu S, Bakkal K, Basar H. Intravenous paracetamol improves the quality of postoperative analgesia but does not decrease narcotic requirements. J Neurosurg Anesthesiol. 2008 Jul;20(3):169-73. doi: 10.1097/ANA.0b013e3181705cfb. |
| 22313079 | Background | Brett CN, Barnett SG, Pearson J. Postoperative plasma paracetamol levels following oral or intravenous paracetamol administration: a double-blind randomised controlled trial. Anaesth Intensive Care. 2012 Jan;40(1):166-71. doi: 10.1177/0310057X1204000121. |
| 23220855 | Background | Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6. |
| 26681907 | Background | Wang S, Saha R, Shah N, Hanna A, DeMuro J, Calixte R, Brathwaite C. Effect of Intravenous Acetaminophen on Postoperative Opioid Use in Bariatric Surgery Patients. P T. 2015 Dec;40(12):847-50. |
| 26587407 | Background | Bameshki A, Peivandi Yazdi A, Sheybani S, Rezaei Boroujerdi H, Taghavi Gilani M. The Assessment of Addition of Either Intravenous Paracetamol or Diclofenac Suppositories to Patient-Controlled Morphine Analgesia for Postgastrectomy Pain Control. Anesth Pain Med. 2015 Oct 10;5(5):e29688. doi: 10.5812/aapm.29688. eCollection 2015 Oct. |
| 26525369 | Background | Strode MA, Sherman W, Mangieri CW, Bland CM, Sparks PJ, Faler BJ, Prasad BM, Choi YU. Randomized trial of OFIRMEV versus placebo for pain management after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2016 May;12(4):772-777. doi: 10.1016/j.soard.2015.08.512. Epub 2015 Aug 29. |
| 25614351 | Background | Saurabh S, Smith JK, Pedersen M, Jose P, Nau P, Samuel I. Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):424-30. doi: 10.1016/j.soard.2014.09.017. Epub 2014 Sep 30. |
| 25521841 | Background | Song K, Melroy MJ, Whipple OC. Optimizing multimodal analgesia with intravenous acetaminophen and opioids in postoperative bariatric patients. Pharmacotherapy. 2014 Dec;34 Suppl 1:14S-21S. doi: 10.1002/phar.1517. |
| 26514714 | Background | Ziolkowski K, Kaufman J, Jambunathan J, Berge J, Menet L, Chappy S, Messerschmidt M. The Clinical Use of Intravenous Acetaminophen Postoperatively on Patients Who Have Undergone Bowel Surgery. AORN J. 2015 Nov;102(5):515.e1-515.e10. doi: 10.1016/j.aorn.2015.09.011. |
| 21353105 | Background | Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011. |
| 23433945 | Background | Apfel CC, Turan A, Souza K, Pergolizzi J, Hornuss C. Intravenous acetaminophen reduces postoperative nausea and vomiting: a systematic review and meta-analysis. Pain. 2013 May;154(5):677-689. doi: 10.1016/j.pain.2012.12.025. Epub 2013 Jan 11. |
| 12243288 | Background | Guha A, Scawn ND, Rogers SA, Pennefather SH, Russell GN. Gastric emptying in post-thoracotomy patients receiving a thoracic fentanyl-bupivacaine epidural infusion. Eur J Anaesthesiol. 2002 Sep;19(9):652-7. doi: 10.1017/s0265021502001072. |
| 9824782 | Background | Yuan CS, Foss JF, O'Connor M, Roizen MF, Moss J. Effects of low-dose morphine on gastric emptying in healthy volunteers. J Clin Pharmacol. 1998 Nov;38(11):1017-20. doi: 10.1177/009127009803801105. |
| 26157186 | Background | Jibril F, Sharaby S, Mohamed A, Wilby KJ. Intravenous versus Oral Acetaminophen for Pain: Systematic Review of Current Evidence to Support Clinical Decision-Making. Can J Hosp Pharm. 2015 May-Jun;68(3):238-47. doi: 10.4212/cjhp.v68i3.1458. |
| 26842692 | Background | El Chaar M, Stoltzfus J, Claros L, Wasylik T. IV Acetaminophen Results in Lower Hospital Costs and Emergency Room Visits Following Bariatric Surgery: a Double-Blind, Prospective, Randomized Trial in a Single Accredited Bariatric Center. J Gastrointest Surg. 2016 Apr;20(4):715-24. doi: 10.1007/s11605-016-3088-0. Epub 2016 Feb 2. |
| 24433365 | Background | Apfel CC, Souza K, Portillo J, Dalal P, Bergese SD. Patient satisfaction with intravenous acetaminophen: a pooled analysis of five randomized, placebo-controlled studies in the acute postoperative setting. J Healthc Qual. 2015 May-Jun;37(3):155-62. doi: 10.1111/jhq.12062. |
| 34498068 | Derived | Subramaniam K, Esper SA, Mallikarjun K, Dickson A, Ruppert DrPH K, Drabek T, Wong H, Holder-Murray J. The Effect of Scheduled Intravenous Acetaminophen in an Enhanced Recovery Protocol Pathway in Patients Undergoing Major Abdominal Procedures: A Prospective, Randomized, and Placebo-Controlled Clinical Trial. Pain Med. 2022 Jan 3;23(1):10-18. doi: 10.1093/pm/pnab272. |
| Sodium Chloride 0.9%, Intravenous |
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. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen Injectable Product | 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 |
| BG001 | Sodium Chloride 0.9%, Intravenous | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Basal Metabolic Index | Median | Inter-Quartile Range | kg/m^2 |
| |||||||||||||||
| Charlson Comorbidity Index | 1 = Myocardial infarction history, CHF, PVD (aortic aneurism ≥6 cm), cerebrovascular disease: cerebrovascular accident +/- transient ischaemic attack, dementia, CPD, connective tissue disease, peptic ulcer disease, mild liver disease (w/o portal hypertension, includes chronic hepatitis), diabetes w/o end-organ damage (excludes diet-controlled) 2 = Hemiplegia, moderate/severe renal disease, diabetes w/ end-organ damage, tumour w/o metastases (<5 years from diagnosis), leukaemia, lymphoma 3 = Moderate/severe liver disease 6 = Metastatic solid tumour, AIDS. Add 1 for each decade >40yr. | Count of Participants | Participants |
| |||||||||||||||
| American Society of Anesthesiologists Classification | I = Healthy patients II = Mild to moderate systemic disease caused by the surgical condition or by other pathological processes, and medically well controlled III = Severe disease process which limits activity but is not incapacitating IV = Severe incapacitating disease process that is a constant threat to life V = Moribund patient not expected to survive 24 hours with or without an operation VI = Declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
| |||||||||||||||
| Number of participants taking medications for mental health | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
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| Coronary artery disease | Count of Participants | Participants |
| ||||||||||||||||
| Congestive failure | Count of Participants | Participants |
| ||||||||||||||||
| Atrial fibrillation | Count of Participants | Participants |
| ||||||||||||||||
| Pulmonary disease | Count of Participants | Participants |
| ||||||||||||||||
| Malignancy | Count of Participants | Participants |
| ||||||||||||||||
| Preoperative serum creatinine | Median | Inter-Quartile Range | (mg/dL) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 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. |
|
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| ||||||||||||||||||||||||||||||
| 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. | Posted | Median | Inter-Quartile Range | 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. | Posted | Median | Inter-Quartile Range | minutes | 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. | Posted | Median | Inter-Quartile Range | hours | 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. | Posted | Median | Inter-Quartile Range | hours | 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. | Posted | Median | Inter-Quartile Range | hours | 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. | Posted | Median | Inter-Quartile Range | days | 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. | Posted | Count of Participants | Participants | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 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. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Count of Participants | Participants | 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 | Posted | Median | Inter-Quartile Range | Z-scores (difference compared to the pop | These measurements will take place at 30-days post hospital discharge |
|
30 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen Injectable Product | 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 | 0 | 76 | 3 | 76 | 8 | 76 |
| EG001 | Sodium Chloride 0.9%, Intravenous | 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. | 0 | 78 | 3 | 78 | 8 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pnemonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anastomotic Leak | Surgical and medical procedures | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Prolonged Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatic Leak | Surgical and medical procedures | Systematic Assessment |
| ||
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathirvel Subramaniam MD MPH FASE | University of Pittsburgh School of Medicine / UPMC | 7247995852 | subramaniamk@upmc.edu |
| Oct 6, 2020 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D010182 | Pancreatic Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 1 |
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| 2 |
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| >2 |
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| III |
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| IV |
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