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

NCT ID: NCT01823224

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-09-30

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)

Conditions

Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group 1

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 Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Group 2

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Acetaminophen is comercially referred to as Tylenol.; Acetaminophen is comercially referred to as Tylenol.

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Defense and Veterans Center for Integrative Pain Management

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony R Plunkett, MD

Role: PRINCIPAL_INVESTIGATOR

Womack Army Medical Center

Locations

Womack Army Medical Center

Fort Bragg, North Carolina, United States

Countries

United States

Other Identifiers

380250

Identifier Type: -

Identifier Source: org_study_id