IVPCA in the Management of Pain Following Major Intracranial Surgery

Johns Hopkins University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Intracranial Surgery

Treatments: Drug: PRN fentanyl; Drug: PCA fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT00286221

NA_00001283

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

159 participants in 4 patient groups

Supratentorial PCA fentanyl

Experimental group

Treatment:

Drug: PCA fentanyl

Supratentorial PRN fentanyl

Active Comparator group

Treatment:

Drug: PRN fentanyl

Infratentorial PCA fentanyl

Experimental group

Treatment:

Drug: PCA fentanyl

Infratentorial PRN fentanyl

Active Comparator group

Treatment:

Drug: PRN fentanyl