The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period

NCT01739699 | Completed Phase 4 Results

• 1 other identifier: EH11-380
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Craniotomy; Brain Surgery

Keywords

craniotomy; brain surgery; acetaminophen; Tylenol

Outcome Measures

Primary Outcomes (1)

• Opioid Requirement After Surgery

  The purpose of the study was to determine whether more patients undergoing craniotomies would not require any opioids (i.e., opioid consumption reduced to zero) during the first 24 postoperative hours when receiving intravenous (IV) acetaminophen during that time compared to those receiving placebo (normal saline).

  during first 24 hours after surgery

Secondary Outcomes (9)

• Time to Rescue Medication in Both Groups

  0 to 24 hours after surgery

• Amount of Rescue Medication in PACU in Both Groups

  0 to 24 hours after surgery

• Median Difference in ICU Length of Stay/Hospital Length of Stay Between Both Groups

  from 0 to estimated 24 hours after surgery

• Number of Participants Who Had a Successful Neurologic Exams Between Intervention and Placebo Group as Determined by a Neurosurgical Provider by Answering Either Yes or No

  from 0 to estimated maximum of 24 hours after surgery

• Median Difference in Temperature Between Intervention and Placebo Groups

  from 0 to estimated maximum 24 hours after surgery

Study Arms (2)

Acetaminophen

EXPERIMENTAL

Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.

Drug: Acetaminophen

Placebo

OTHER

Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure.

Drug: Placebo

Interventions

Acetaminophen DRUG

Also known as: Tylenol

Acetaminophen

Placebo DRUG

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead
• Cadence Pharmaceuticals: collaborator

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Interventions

Acetaminophen; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

1. Underpowered. 2. Nurses used the local standard order sets. 3. Dexamethasone dose was not standardized 4. Long acting opioids or NSAIDS of any type were not administered. 5. Patients observed every 8 hours for 24 hours postoperatively.

Results Point of Contact

• Title: Dr. Steven Greenberg
• Organization: Northshore University Healthsystem, Evanston Hospital

sbgreenb@gmail.com

8475702760

Study Officials

• Steven Greenberg, MD

  NorthShore University Health Sytem - Evanston Hospital Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 3, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: January 20, 2017
• Last Updated: November 4, 2021
• Results First Posted: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: anytime
• Access Criteria: anytime

Locations

US (1)