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

Defense and Veterans Center for Integrative Pain Management

Status: Completed

Conditions: Laparoscopic Cholecystectomy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01823224

380250

Details and patient eligibility

About

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.

Full 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)

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

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

Group 2

Experimental group

Description:

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.

Treatment:

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