Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT)
- PMID: 32187663
- DOI: 10.1002/bjs.11520
Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT)
Abstract
Background: The benefit of a perianal block as an adjunct to general or regional anaesthesia is debated. This RCT aimed to compare pain at 24 h and up to 14 days after proctological surgery in patients with and without a perianal block.
Methods: Between January 2018 and April 2019, patients were allocated to receive a perianal block with ropivacaine or placebo as an adjunct to anaesthesia. Patients, surgeons and assessors were blinded. The primary outcome was pain measured on a numerical rating scale (NRS) after 24 h. Secondary outcomes were need for rescue analgesia, and pain after 1, 2, 3, 6 and 12 h. The mean, rest and maximum NRS scores were measured for 14 days.
Results: A total of 138 patients were included, of whom 46 and 44 received general anaesthesia with or without ropivacaine respectively, and 23 and 25 received spinal anaesthesia with or without ropivacaine respectively (P = 0·858). The mean NRS score differed significantly at 24 h (mean(s.d.) 1·1(0·1) versus 2·3(0·2); P < 0·001), but not at 1 h (1·4(0·2) versus 2·2(0·3); P = 0·051). The NRS score was lower with use of ropivacaine at 2 h (1·0(0·2) versus 1·6(0·2); P = 0·045), 3 h (0·9(0·2) versus 1·5(0·2); P = 0·022), 6 h (1·1(0·2) versus 1·8(0·2); P = 0·042) and 12 h (1·2(0·2) versus 1·8(0·2); P = 0·034). The use of oral morphine equivalents was 10·2(1·4) and 16·6(2·5) mg with and without ropivacaine respectively (P = 0·028). The mean and maximum NRS scores within 14 days were lower when ropivacaine was used (95 per cent c.i. for difference 0·14 to 0·49 (P = 0·002) and 0·39 to 0·63 (P < 0·001) respectively). There was no injection-associated morbidity.
Conclusion: Perianal block as an adjunct to general or regional anaesthesia should be recommended for proctological surgery. It yields a reduction in pain, a reduced need for opioids, and a faster recovery with minimal risk of adverse events. Registration number: NCT03405922 ( http://www.clinicaltrials.gov).
Antecedentes: Se discute el beneficio del bloqueo perianal asociado a la anestesia general o regional. Este ensayo clínico aleatorizado tuvo como objetivo comparar el dolor a las 24 horas y hasta los 14 días tras cirugía proctológica en pacientes con y sin bloqueo perianal. MÉTODOS: Entre enero de 2018 y abril de 2019 se asignaron los pacientes para recibir un bloqueo perianal con ropivacaína o placebo como complemento de la anestesia. Los pacientes, los cirujanos y los evaluadores desconocían el grupo al que habían sido aleatorizados los pacientes. La variable principal fue el dolor a las 24 horas medido en una escala de numérica (numeric rating scale, NRS). Las variables secundarias fueron la necesidad de analgesia de rescate y el dolor a las 1, 2, 3, 6 y 12 horas. También se obtuvieron las puntuaciones media, en reposo y máxima de NRS durante 14 días.
Resultados: Se incluyeron 138 pacientes, de los que 46 recibieron anestesia general con ropivacaína, 44 anestesia general sin ropivacaína, 23 anestesia raquídea con ropivacaína y 25 anestesia raquídea sin ropivacaína (P = 0,858). La puntuación media de NRS fue significativamente diferente a las 24 horas (1,1 ± 0,1 versus 2,3 ± 0,2; P < 0,001), pero no en la primera hora (1,4 ± 0,2 versus 2,2 ± 0,3; P = 0,051). La puntuación NRS fue inferior para la ropivacaína a las 2 horas (1,0 ± 0,2 versus 1,6 ± 0,2; P = 0,045), 3 horas (0,9 ± 0,2 versus 1,5 ± 0,2; P = 0,022), 6 horas (1,1 ± 0,2 versus 1,8 ± 0,2; P = 0,042) y 12 horas (1,2 ± 0,2 versus 1,8 ± 0,2; P = 0,034). El uso equivalentes de morfina por vía oral fue de 10,2 ± 1,4 mg y 16,6 ± 2,5 mg (P = 0,028). Las puntuaciones media y máxima de NRS en los 14 días fueron más bajas para la ropivacaína (i.c. del 95%: 0,14-0,49, P = 0,002 y de 0,39-0,63, P < 0,0001, respectivamente). No hubo morbididad asociada a la inyección. CONCLUSIÓN: Se recomienda asociar el bloqueo perianal a la anestesia general o regional en la cirugía proctológica. Este procedimiento conlleva una reducción del dolor, una menor necesidad de opioides y una recuperación más rápida con efectos adversos escasos.
© 2020 BJS Society Ltd Published by John Wiley & Sons Ltd.
Comment in
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Author response to: Comment on: Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).Br J Surg. 2020 Aug;107(9):e352. doi: 10.1002/bjs.11744. Epub 2020 Jun 7. Br J Surg. 2020. PMID: 32506421 No abstract available.
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Comment on: Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).Br J Surg. 2020 Aug;107(9):e351. doi: 10.1002/bjs.11745. Epub 2020 Jun 7. Br J Surg. 2020. PMID: 32506458 No abstract available.
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