IVPCA in the Management of Pain Following Major Intracranial Surgery

August 28, 2017 updated by: Johns Hopkins University

The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial

This is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (IVPCA) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid consumption, costs, sedation level, length of hospital stay, patient satisfaction, and complications in patients randomized to receive either pro re nata (PRN) or IVPCA opioids. We hypothesize that IVPCA will be more efficacious than PRN opioids in the treatment of postoperative without an increased incidence of adverse effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults undergoing intracranial surgery

Exclusion Criteria:

  • Patient refusal
  • Pregnancy
  • Aphasia
  • Respiratory failure
  • Allergy/intolerance to fentanyl
  • Opioids use
  • History of opioid-dependent pain,
  • Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment
  • Mental or physical limitations that would prevent patient assessment or PCA use
  • Chronic painful conditions unrelated to the reason for surgery,
  • Clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation
  • Patient is unable to initiate a bolus dose of IVPCA fentanyl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supratentorial PCA fentanyl
Drug: PCA fentanyl
PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
Other Names:
  • PCA
Active Comparator: Supratentorial PRN fentanyl
Drug: PRN fentanyl
IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Other Names:
  • IV fentanyl
Experimental: Infratentorial PCA fentanyl
Drug: PCA fentanyl
PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
Other Names:
  • PCA
Active Comparator: Infratentorial PRN fentanyl
Drug: PRN fentanyl
IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Other Names:
  • IV fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hourly Pain Scores
Time Frame: Up to 16 hours
Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)
Up to 16 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fentanyl Consumption
Time Frame: Up to 16 hours
the amount of fentanyl is that administered in response to corresponding rest pain levels. Thus, the 0 hour indicates the amount of fentanyl administered from the time of admission until the end of the first hour. Also note that once pain assessments are made every other hour (e.g., 10, 12, 14, and 16), the analgesic totals indicated are for the corresponding 2-hour period after the pain assessment, and were halved to estimate the hourly rate of analgesic consumption.
Up to 16 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Bradford Winters, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

February 1, 2006

First Submitted That Met QC Criteria

February 1, 2006

First Posted (Estimate)

February 3, 2006

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00001283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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