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

Not Applicable

Completed

Interventions: Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"
Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"

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)

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Group 1	IV tylenol 1000mg and 2 oral capsule "sugar pills"	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
Group 2	2 capsules Oral Tylenol 2000 mg and IV "salt water"	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.

Primary Outcome Measures

Name	Time	Method
Pain	24 hours after discharge	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.

Secondary Outcome Measures

Name	Time	Method
Total Opioid Consumption From Time of First Waking to T24	every 6 hours for 24 hours	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