IVPCA in the Management of Pain Following Major Intracranial Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Intracranial Surgery

Intervention / Treatment
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* Drug: PCA fentanyl
* Drug: PRN fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supratentorial PCA fentanyl<br> | Drug: PCA fentanyl<br>* 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<br>* Other names: PCA;|
| Active Comparator: Supratentorial PRN fentanyl<br> | Drug: PRN fentanyl<br>* IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))<br>* Other names: IV fentanyl;|
| Experimental: Infratentorial PCA fentanyl<br> | Drug: PCA fentanyl<br>* 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<br>* Other names: PCA;|
| Active Comparator: Infratentorial PRN fentanyl<br> | Drug: PRN fentanyl<br>* IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))<br>* Other names: IV fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hourly Pain Scores | 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 | 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 |