IVPCA in the Management of Pain Following Major Intracranial Surgery

Phase 2

Completed

• Conditions: Intracranial Surgery
• Interventions: Drug: PCA fentanyl; Drug: PRN fentanyl

• Registration Number: NCT00286221
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-03
• Study Start: 2006-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2017-07-24
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-28
• Last Update Submitted: 2017-08-28
• Results First Posted: 2017-09-26
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infratentorial PCA fentanyl	PCA fentanyl	-
Supratentorial PRN fentanyl	PRN fentanyl	-
Supratentorial PCA fentanyl	PCA fentanyl	-
Infratentorial PRN fentanyl	PRN fentanyl	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fentanyl Consumption	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.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States