The Efficacy of Intravenous Acetaminophen During The Perioperative Period Of Neurosurgical Patients Undergoing Craniotomies

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by NorthShore University HealthSystem Research Institute
Sponsor:
Collaborator:
Cadence Pharmaceuticals
Information provided by (Responsible Party):
Dr. Steven Greenberg, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01739699
First received: November 28, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned.

The following general perioperative data will be recorded: patient information/preoperative data, procedural information, postoperative information, and overall satisfaction of pain management at 24 hours after surgery.

Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require no opioids in the first 24 hour postoperative period. With the use of intravenous acetaminophen, it is hypothesized that the number of patients that do not require opioids in the first 24 hours after surgery will double.


Condition Intervention Phase
Craniotomy
Brain Surgery
Drug: Acetaminophen
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Intravenous Acetaminophen During The Perioperative Period Of Neurosurgical Patients Undergoing Craniotomies

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Opioid requirement after surgery [ Time Frame: during first 24 hours after surgery ] [ Designated as safety issue: No ]
    Amount of opioid requirement in addition to the study intervention(placebo or acetaminophen) will be recorded for the first 24 hours after surgery.


Secondary Outcome Measures:
  • Time to rescue medication in both groups [ Time Frame: 0 to 24 hours after surgery ] [ Designated as safety issue: No ]
  • Amount of rescue medication in PACU in both groups [ Time Frame: 0 to 24 hours after surgery ] [ Designated as safety issue: No ]
  • Median difference in ICU length of stay/hospital length of stay between both groups [ Time Frame: from 0 to estimated maximum of 7 days after surgery ] [ Designated as safety issue: No ]
  • Number of successful neurologic exams between intervention and placebo group as determined by a neurosurgical provider by answering either Yes or No [ Time Frame: from 0 to estimated maximum of 7 days after surgery ] [ Designated as safety issue: No ]
  • Median difference in temperature between intervention and placebo groups [ Time Frame: from 0 to estimated maximum of 7 days after surgery ] [ Designated as safety issue: No ]
  • Sedation scores measured by RASS every 8 hours for 24 hours in both groups [ Time Frame: during first 24 hours after surgery ] [ Designated as safety issue: No ]
  • Pain VAS scores (1-10) every 8 hours for 24 hours in both groups [ Time Frame: during first 24 hours after surgery ] [ Designated as safety issue: No ]
  • Delirium measured by CAM-ICU every 8 hours for 24 hours in both groups [ Time Frame: during first 24 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: January 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetaminophen
Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.
Drug: Acetaminophen
Other Name: Tylenol
Placebo
Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure.
Drug: Placebo
Other Name: normal saline

Detailed Description:

This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned.

The following information will be recorded for each patient enrolled in this study:

  • Patient information/Preoperative Data

    • Age, sex, height, weight, Body Surface Area (BSA)
    • Disease specific information
    • Primary diagnosis
    • Pertinent medical history
    • Medications
    • Pertinent changes in patient status
  • Procedural information

    • Operation type
    • Preoperative anesthetic medications
    • Induction meds, intra-operative anesthetic meds, and post-operative anesthetic meds, pressors, anti-hypertensives
    • Duration of Surgery and Intubation
    • Amount of dilaudid equivalent narcotics
  • Postoperative Information

    • Amount of narcotics administered in the PACU
    • Amount of narcotics administered in the first 24 hour postoperative period
    • Amount of non-narcotic analgesics administered in the first 24 hour postoperative period
    • Time to first rescue analgesic in the PACU
    • Amount of first rescue medication recorded
    • Assessment of Pain Intensity at T0.5 (30min into PACU stay) and T24 (24 hours after end of surgery) (A 10-cm VAS scale will be used and labeled no pain at its left terminus and worst pain imaginable at its right terminus)
    • Temperature in degrees centigrade every 8 hours for 24hours.
    • CAM-ICU is performed by ICU nurses to detect delirium in patients every 8 hours and will be documented on a data collection sheet for the first 24 hours
    • RASS is a sedation scoring system that is used in our ICU and is documented every 8 hours by ICU nursing. We will record the RASS score for the first 24 hours on a data collection sheet as documented by the ICU nurse.
    • Overall satisfaction score at 24 hrs. "Overall satisfaction with pain management" (scale 1 - 100)

Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require no opioids in the first 24 hour postoperative period. With the use of intravenous acetaminophen, it is hypothesized that the number of patients that do not require opioids in the first 24 hours after surgery will double.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject are able to provide informed consent prior to participation in the study
  • Subjects must be scheduled to undergo elective open craniotomy procedure of > 2 hour duration
  • Subjects must be >18 years old but less than 90 years old
  • Subjects must have an American Society of Anesthesiologists (ASA) class I-IV
  • Subjects must have the ability to communicate meaningfully with the investigator staff and read/understand the study procedures and the use of pain scales

Exclusion Criteria:

  • Subjects used opioids or tramadol daily for >7 days before study medication administration
  • Subjects had been treated with any of the following within 14 days of surgery: chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian
  • Subjects who have a chronic pain condition, significant medical disease or laboratory abnormality that in the investigator's judgment could compromise the subject's welfare
  • Subjects with known hypersensitivity to opioids, acetaminophen or the inactive ingredients
  • Subjects with known or suspected history of alcohol or drug abuse or dependence in the previous 2 years prior to the proposed surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739699

Contacts
Contact: Steven Greenberg, MD 847-570-2760 sbgreenb@gmail.com
Contact: Shivani Patel 847-570-2760 spatel6@northshore.org

Locations
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Steven Greenberg, MD         
Principal Investigator: Steven Greenberg, MD         
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Cadence Pharmaceuticals
Investigators
Principal Investigator: Steven Greenberg, MD NorthShore University Health Sytem - Evanston Hospital Department of Anesthesia
  More Information

No publications provided

Responsible Party: Dr. Steven Greenberg, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01739699     History of Changes
Other Study ID Numbers: EH11-380
Study First Received: November 28, 2012
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
craniotomy
brain surgery
acetaminophen
Tylenol

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014