IVPCA in the Management of Pain Following Major Intracranial Surgery

NCT ID: NCT00286221

Last Updated: 2017-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2010-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Supratentorial PCA fentanyl

Group Type: EXPERIMENTAL

PCA fentanyl

Intervention Type: 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

Supratentorial PRN fentanyl

Group Type: ACTIVE_COMPARATOR

PRN fentanyl

Intervention Type: DRUG

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

Infratentorial PCA fentanyl

Group Type: EXPERIMENTAL

PCA fentanyl

Intervention Type: 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

Infratentorial PRN fentanyl

Group Type: ACTIVE_COMPARATOR

PRN fentanyl

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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))

Intervention Type: DRUG

Other Intervention Names

PCA; IV fentanyl

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradford Winters, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19249923 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22156333 (View on PubMed)

Other Identifiers

NA_00001283

Identifier Type: -

Identifier Source: org_study_id