Efficacy of Continuous Intrathecal Infusion Trialing with a Mixture of Fentanyl and Bupivacaine in Chronic Low Back Pain Patients.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2025;13(24):20 Pain Med. 2023 01-Jul;():. 10.1093/pm/pnac195What this means for my practice?
Intrathecal fentanyl/bupivacaine is significantly more effective than saline for short-term pain reduction during screening trials, and responses appear predictive of favourable 12-month outcomes after IDDS implantation. Clinically, this supports using active-controlled, blinded continuous infusion trials rather than single-shot or uncontrolled methods. A major limitation is the strong placebo effect of saline when administered first, highlighting potential bias in standard non-blinded trials and the need for improved trialing methodology.
Study Summary
Thirty-six patients with refractory chronic low back pain were randomized to receive either intrathecal fentanyl/bupivacaine followed by saline or the reverse sequence, with each infusion delivered continuously for 14–18 hours and separated by a 6-hour saline washout. The primary outcome was the change in Numerical Rating Scale (NRS) pain scores from baseline to the end of each infusion. Overall, the results of the study revealed that both infusions produced measurable reductions in pain, but fentanyl/bupivacaine led to significantly greater improvements than saline for pain at rest and during activity. A notable placebo effect occurred when saline was administered first.
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