IVPCA in the Management of Pain Following Major Intracranial Surgery

NCT00286221 | Completed Phase 2 Results

• 1 other identifier: NA_00001283
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Surgery

Outcome Measures

Primary Outcomes (1)

• Hourly Pain Scores

  Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)

  Up to 16 hours

Secondary Outcomes (1)

• Fentanyl Consumption

  Up to 16 hours

Study Arms (4)

Supratentorial PCA fentanyl

EXPERIMENTAL

Drug: PCA fentanyl

Supratentorial PRN fentanyl

ACTIVE COMPARATOR

Drug: PRN fentanyl

Infratentorial PCA fentanyl

EXPERIMENTAL

Drug: PCA fentanyl

Infratentorial PRN fentanyl

ACTIVE COMPARATOR

Drug: PRN fentanyl

Interventions

PCA fentanyl DRUG

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

Also known as: PCA

Infratentorial PCA fentanyl; Supratentorial PCA fentanyl

PRN fentanyl DRUG

IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))

Also known as: IV fentanyl

Infratentorial PRN fentanyl; Supratentorial PRN fentanyl

Eligibility Criteria

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

You may qualify if:

• Adults undergoing intracranial surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Morad AH, Winters BD, Yaster M, Stevens RD, White ED, Thompson RE, Weingart JD, Gottschalk A. Efficacy of intravenous patient-controlled analgesia after supratentorial intracranial surgery: a prospective randomized controlled trial. Clinical article. J Neurosurg. 2009 Aug;111(2):343-50. doi: 10.3171/2008.11.JNS08797.

  PMID: 19249923 RESULT

• Morad A, Winters B, Stevens R, White E, Weingart J, Yaster M, Gottschalk A. The efficacy of intravenous patient-controlled analgesia after intracranial surgery of the posterior fossa: a prospective, randomized controlled trial. Anesth Analg. 2012 Feb;114(2):416-23. doi: 10.1213/ANE.0b013e31823f0c5a. Epub 2011 Dec 9.

  PMID: 22156333 RESULT

MeSH Terms

Interventions

Passive Cutaneous Anaphylaxis; Fentanyl

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Bradford Winters
• Organization: Johns Hopkins School of Medicine

bwinter1@jh.edu

4109559080

Study Officials

• Bradford Winters, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 3, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 26, 2017
• Results First Posted: September 26, 2017

Record last verified: 2017-08

Locations

US (1)