Direct intraoperative versus percutaneous computed tomographyguided celiac plexus neurolysis in non-resectable pancreatic cancer: A randomized, controlled, non-inferiority study.

BACKGROUND: Celiac plexus neurolysis (CPN) has been used to control pancreatic cancer (PC) pain, up to our knowledge, there is no study compared intraoperative CPN and computed tomography (CT)-guided techniques. OBJECTIVES: To compare the effects of intraoperative and CT-guided CPN in unresectable PC on pain intensity and analgesic requirements. METHODS: A total of 90 patients were enrolled in this prospective, randomized, open label, controlled, non-inferiority study, 20 patients were excluded or lost to follow up. The patients were randomly allocated to either intraoperative or CT-guided CPN group. A mixture of 20 mL ethanol 90%, 100 mg lignocaine and 5 mg dexamethasone was infused on each side of the aorta in both groups. Visual analogue score (VAS) and oral daily tramadol consumption were recorded at day 7, 14, 30, 60, 120 and 180 days after intervention. Occurrence of any intervention related complications were reported. RESULTS: Median VAS was similar in both intraoperative and CT-guided CPN groups from day 7 up to 180 days after intervention. The median daily analgesic consumption of oral tramadol (mg) was comparable in both intraoperative and CT-guided CPN groups after intervention at day 7 (50 versus 50), day14 (50 versus 50), day 30 (50 versus 50), day 60 (50 versus 50), day 120 (100 versus 75) and day 180 (100 versus 100). The incidence of diarrhea, vomiting, hypotension and back pain was similar in both groups. CONCLUSION: Intraoperative CPN is non-inferior to CT-guided CPN as both techniques were similarly associated with reduced pain severity and analgesics requirements.

Neurólisis del plexo celiaco intraoperatoria directa frente a percutánea guiada por tomografía computarizada en el cáncer de páncreas no operable: estudio aleatorizado, controlado y de no inferioridad / Direct intraoperative versus percutaneous computed tomographyguided celiac plexus neurolysis in non-resectable pancreatic cancer: A randomized, controlled, non-inferiority study

Antecedentes: Se ha utilizado la neurólisis del plexo celiaco (NPC) para controlar el dolor producido por el cáncer de páncreas (CP) y, a nuestro entender, no existe ningún estudio que compare las técnicas de NPC intraoperatoria y NPC guiada por tomografía computarizada (TC). Objetivos: Comparar los efectos de NPC intraoperatoria y NPC guiada por TC en el CP no operable en cuanto a intensidad del dolor y necesidad de analgésicos. Métodos: Se incluyó a un total de 90 pacientes en este estudio prospectivo, aleatorizado, abierto, controlado y de no inferioridad, en el que se excluyó o perdió a 20 pacientes durante el seguimiento. Se asignó aleatoriamente a los pacientes en el grupo de NPC intraoperatoria o el grupo de NPC guiada por TC. En ambos grupos se inyectó una mezcla de 20ml de etanol al 90%, 100mg de lidocaína y 5mg de dexametasona en cada lado de la aorta. Se registraron la escala visual analógica (EVA) y el consumo oral diario de tramadol los días 7.°, 14.°, 30.°, 60.°, 120.° y 180.° tras la intervención. Se reportó la presencia de cualquier complicación relacionada con la intervención. Resultados: La puntuación EVA media fue similar en ambos grupos de NPC intraoperatoria y NPC guiada por TC desde el 7.° al 180.° posteriores la intervención. El consumo medio diario de analgésico (miligramos de tramadol por vía oral) fue comparable en ambos grupos tras la intervención en los días 7.°(50 frente a 50), 14.°(50 frente a 50), 3.0°(50 frente a 50), 60.°(50 frente a 50), 120.°(100 frente a 75) y 180.° (100 frente a 100). La incidencia de diarrea, vómitos, hipotensión y dolor de espalda fue similar en ambos grupos. Conclusión: La NPC intraoperatoria no es inferior a la NPC guiada por TC, ya que la asociación de ambas técnicas a la reducción de la gravedad del dolor y a las necesidades de analgésicos fue similar.(AU)

Background: Celiac plexus neurolysis (CPN) has been used to control pancreatic cancer (PC) pain, up to our knowledge, there is no study compared intraoperative CPN and computed tomography (CT)-guided techniques. Objectives: To compare the effects of intraoperative and CT-guided CPN in unresectable PC on pain intensity and analgesic requirements. Methods: A total of 90 patients were enrolled in this prospective, randomized, open label, controlled, non-inferiority study, 20 patients were excluded or lost to follow up. The patients were randomly allocated to either intraoperative or CT-guided CPN group. A mixture of 20ml ethanol 90%, 100mg lignocaine and 5mg dexamethasone was infused on each side of the aorta in both groups. Visual analogue score (VAS) and oral daily tramadol consumption were recorded at day 7, 14, 30, 60, 120 and 180 days after intervention. Occurrence of any intervention related complications were reported. Results: Median VAS was similar in both intraoperative and CT-guided CPN groups from day 7 up to 180 days after intervention. The median daily analgesic consumption of oral tramadol (mg) was comparable in both intraoperative and CT-guided CPN groups after intervention at day 7 (50 versus 50), day14 (50 versus 50), day 30 (50 versus 50), day 60 (50 versus 50), day 120 (100 versus 75) and day 180 (100 versus 100). The incidence of diarrhea, vomiting, hypotension and back pain was similar in both groups. Conclusion: Intraoperative CPN is non-inferior to CT-guided CPN as both techniques were similarly associated with reduced pain severity and analgesics requirements.(AU)

Direct intraoperative versus percutaneous computed tomographyguided celiac plexus neurolysis in non-resectable pancreatic cancer: A randomized, controlled, non-inferiority study. / Neurólisis del plexo celiaco intraoperatoria directa frente a percutánea guiada por tomografía computarizada en el cáncer de páncreas no operable: estudio aleatorizado, controlado y de no inferioridad.

BACKGROUND: Celiac plexus neurolysis (CPN) has been used to control pancreatic cancer (PC) pain, up to our knowledge, there is no study compared intraoperative CPN and computed tomography (CT)-guided techniques. OBJECTIVES: To compare the effects of intraoperative and CT-guided CPN in unresectable PC on pain intensity and analgesic requirements. METHODS: A total of 90 patients were enrolled in this prospective, randomized, open label, controlled, non-inferiority study, 20 patients were excluded or lost to follow up. The patients were randomly allocated to either intraoperative or CT-guided CPN group. A mixture of 20ml ethanol 90%, 100mg lignocaine and 5mg dexamethasone was infused on each side of the aorta in both groups. Visual analogue score (VAS) and oral daily tramadol consumption were recorded at day 7, 14, 30, 60, 120 and 180 days after intervention. Occurrence of any intervention related complications were reported. RESULTS: Median VAS was similar in both intraoperative and CT-guided CPN groups from day 7 up to 180 days after intervention. The median daily analgesic consumption of oral tramadol (mg) was comparable in both intraoperative and CT-guided CPN groups after intervention at day 7 (50 versus 50), day14 (50 versus 50), day 30 (50 versus 50), day 60 (50 versus 50), day 120 (100 versus 75) and day 180 (100 versus 100). The incidence of diarrhea, vomiting, hypotension and back pain was similar in both groups. CONCLUSION: Intraoperative CPN is non-inferior to CT-guided CPN as both techniques were similarly associated with reduced pain severity and analgesics requirements.