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

Phase 4

Completed

Conditions: Abdominal Wall Hernia
Pancreatic Diseases
Bowel Disease
Gastric Disease

Interventions: Drug: Sodium Chloride 0.9%, Intravenous
Drug: Acetaminophen Injectable Product

Registration Number: NCT03198871

Lead Sponsor: Kathirvel Subramaniam

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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 180

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride 0.9%, Intravenous	Sodium Chloride 0.9%, Intravenous	Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product	Acetaminophen Injectable Product	Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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
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
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.
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.
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.