Efficacy of the Erector Spinae Plane Block (ESPB) versus Fentanyl for alleviating pain in patients with acute severe backache in the Emergency Department: a comparative parallel-group two-arm open label pilot randomized control trial

This study is designed as a comparative parallel group, two arm, open label, pilot randomized control trial to evaluate the efficacy of the Erector Spinae Plane Block versus Fentanyl in managing acute severe backache in patients presenting to the Emergency Department. Eligible participants include individuals aged 18 years or older who present with acute severe lumbar back pain, whether due to mechanical causes, malignancy related pain or trauma after excluding vertebral fractures. Each patient will undergo a thorough history taking and clinical examination. Those who are hemodynamically stable, have no known allergies to the study drugs and score of 7 or more on Defence and Veteran Pain Rating Scale will be enrolled, provided they meet all the inclusion criteria and no exclusion criteria apply. Randomization will be conducted using preformed, computer generated sequences employing a mixed block randomization method. To maintain allocation concealment, the generated sequences will be sealed in opaque envelopes. The primary objective is to evaluate the effectiveness of pain relief achieved six hours post intervention in both the ESPB and Fentanyl arms. The secondary objectives include assessing the safety profile, patient satisfaction and the quantity of rescue analgesic medications required within six hours post intervention, comparing outcomes between the intervention and control groups.