Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control,

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to learn whether perioperative IV (intravenous) administration of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes over the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen, it may result in fewer requests for pain-related intervention such as other oral pain medications.

Detailed Description
-----------------
Subjects were enrolled following the listed inclusion and exclusion criteria. Subjects Eligibility Criteria: Inclusion Criteria: Male and female patients ASA I - III . 18 years of age and older Exclusion Criteria: Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous abdominal surgery Chronic home narcotic use (patient-reported narcotic use for greater than 3 months) Previous Bowel resection, colon surgery, stomach surgery . Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs closest to surgical date or within 6 months prior to surgery Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to surgical date or within 6 months prior to surgery Open or emergency surgery (non-scheduled surgery, surgery that must be performed within 6 hours for this particular surgery) Prior NSAIDS (Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within the last 24 hours Use of intraoperative NSAIDs Contraindication to study drug (including allergic reaction or hypersensitivity to acetaminophen or any of its components; Taking a medication with known interactions with acetaminophen Taking chronic oral acetaminophen, greater than 6 months on a daily basis at a dose greater than 3000mg/day Pregnancy Current or past alcohol abuse (within the past 2 years)

Official Title
-----------------
A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy

Conditions
-----------------
Laparoscopic Cholecystectomy

Intervention / Treatment
-----------------
* Drug: 2 capsules Oral Tylenol 2000 mg and IV salt water
* Drug: IV tylenol 1000mg and 2 oral capsule sugar pills


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients ASA I - III (A system used by anesthesiologists to stratify severity of patients' underlying disease and potential for suffering complications from general anesthesia ), 18 years of age and older Patient must be scheduled for laparoscopic cholecystectomy Exclusion Criteria: Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous abdominal surgery Chronic home narcotic use (patient-reported narcotic use for greater than 3 months) Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs closest to surgical date or within 6 months prior to surgery Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to surgical date or within 6 months prior to surgery Open or emergency surgery (non-scheduled surgery, surgery that must be performed within 6 hours for this particular surgery) Prior NSAIDS(Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within the last 24 hours Use of intraoperative NSAIDs Contraindication to study drug (including allergic reaction or hypersensitivity to acetaminophen or any of its components; On a medication with known interactions with acetaminophen On chronic oral acetaminophen, greater than 6 months on a daily basis at a dose greater than 3000mg/day Pregnancy Current or past alcohol abuse (within the past 2 years)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg | Drug: IV tylenol 1000mg and 2 oral capsule sugar pills<br>* IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group.<br>* Other names: Acetaminophen is comercially referred to as Tylenol.;|
| Experimental: Group 2<br>Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg. | Drug: 2 capsules Oral Tylenol 2000 mg and IV salt water<br>* The participants randomized to receive the '2 capsules Oral Acetaminophen 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly.<br>* Other names: Acetaminophen is comercially referred to as Tylenol.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain. | 24 hours after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption From Time of First Waking to T24 | Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded: Opioid consumption from first waking to T4 Total opioid consumption from T0 to T4 Total opioid consumption from time of first waking to T24 | every 6 hours for 24 hours |