Objective: Failed back surgery syndrome (FBSS) is a common long-term complication following spine surgeries characterized by chronic persistent pain; different strategies of management were employed to deal with it. This clinical trial aims to compare the efficacy of Pregabalin and Gabapentin in the management of this condition.
Methods: A double-blind, randomized, comparative study (clinical trial registry NCT05324761 on 11th April 2022) with two parallel arms with Pregabalin and Gabapentin were used in arms one and two, respectively. Visual analog scale was used for basal and endpoint assessment of pain. T-test and analysis of covariance were used to deal with different variables. A pairwise test was used to compare pairs of means.
Results: Of 66 patients referred to the trial, 64 were eligible, with 60 patients completing the 30 days trial. Both pregabalin and gabapentin effectively reduce pain, with significant p-values of 0.001 for each group. However, the pregabalin group was superior to gabapentin in pain reduction (p=0.001). Gender was an insignificant factor (p=0.574 and p=0.445 for the pregabalin and gabapentin groups, respectively, with a non-significant reduction (p=0.393) for both groups in total. Location of stenosis before surgery and type of surgery performed show non-significant effect on pain reduction for both groups.
Conclusion: Both pregabalin and gabapentin effectively and safely relieve neuropathic pain associated with FBSS; pregabalin was significantly more effective irrespective of the patients' gender.
Keywords: Clinical trial; Gabapentin; Neuropathic pain; Pregabalin.