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

Laparoscopic Cholecystectomy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Laparoscopic Cholecystectomy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:2 capsules Oral Tylenol 2000 mg and IV "salt water"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.

Drug:IV tylenol 1000mg and 2 oral capsule "sugar pills"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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Group 1Group 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 2Group 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.

Study Status

Completed

Start Date: February 2013

Completed Date: September 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Pain

Secondary Outcome: Total Opioid Consumption From Time of First Waking to T24

Study sponsors, principal investigator, and references

Principal Investigator: Anthony R Plunkett, MD

Lead Sponsor: Defense and Veterans Center for Integrative Pain Management

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01823224

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