Extended-release gabapentin for failed back surgery syndrome: results from a randomized double-blind cross-over study

Abstract

Persistent pain after lumbar surgery (failed back surgery syndrome [FBSS]) remains a leading indication for chronic analgesia. However, no analgesics have proven efficacious for this condition. Although trials have evaluated gabapentinoids for chronic low back pain, none of these trials focused solely on FBSS. This randomized, double-blind cross-over trial evaluated the efficacy of gabapentin (1800 mg/day) for FBSS. Eligible patients had a diagnosis of FBBS, an average daily pain score of at least 4 of 10, a neuropathic pain component (indicated by the PainDetect), and reported at least half of their pain radiating in their lower extremity. Participants were randomized to 2, 7-week study periods separated by a 10-day washout. The primary outcome measure was a 0 to 10 numeric rating scale (NRS) of average pain. Secondary measures included the McGill Pain Questionnaire and Patient Global Impression of Change. The treatment effect was analyzed using a mixed effect analysis of covariance with fixed effects for treatment, period, and baseline 7-day mean NRS pain score and a random effect for the participant. The outcome of the model was the mean 7-day NRS score for the last 7 days of each treatment period. Thirty-two participants were randomized and included in the primary analysis; 25 completed both study periods. No difference was detected between treatments on any outcome measure, including the primary (least square mean difference in NRS: −0.01 confidence interval: [−0.22 to 0.20]). Given the escalating rate of complex lumbar surgery, future research to develop novel therapies for this prevalent syndrome is needed.

Optimizing the Management and Outcomes of Failed Back Surgery Syndrome: A Proposal of a Standardized Multidisciplinary Team Care Pathway

“…The UK regulator recently reclassified gabapentinoids as Class C controlled drugs [45]. Furthermore, the effect of pregabalin and gabapentin in reducing the neuropathic leg pain in patients, including those with FBSS, has also been questioned [46, 47]. Hence, the use of gabapentinoid medication in the long term should be carefully reviewed [48].…”

Multimodal management strategies for chronic pain after spinal surgery: a comprehensive review

“…Neuropathic pain caused by nerve damage or dysfunction can initially respond to antiepileptic drugs such as gabapentin and pregabalin, which are specifically designed to manage this type of pain [ 54 ]. Tricyclic antidepressants and selective norepinephrine reuptake inhibitors may also be effective for managing neuropathic pain [ 55 ].…”

Failed Back Surgery Syndrome: No Longer a Surgeon’s Defeat—A Narrative Review

“…Nociceptive pain, resulting from tissue damage or inflammation, may first be treated with over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen or acetaminophen [ 93 ]. If these are ineffective, prescription non-opioid medications, like higher-dose NSAIDs, COX-2 inhibitors, or short-term corticosteroids, may be introduced [ 94 ].…”