RESUMO
Introduction Transversus abdominis plane (TAP) blocks are used for post-operative pain management, but their efficacy remains unclear. We aim to investigate the effect of two TAP block methods in minimally invasive colon surgery. Methods This will be a double-blind, randomised and controlled multicentre trial including 360 adults who are planned for elective minimally invasive colon surgery with curative intent for colon neoplasia. The participants are randomised to one of three arms: active ultrasound-guided TAP (US-TAP) and placebo laparoscopic assisted TAP (L-TAP), placebo US-TAP and active L-TAP, or placebo US-TAP and placebo L-TAP. The primary outcome is morphine dose equivalents administered during the first 24 hours after surgery. Secondary outcomes are pain on the first post-operative day, length of stay, post-operative nausea and vomiting, and quality of recovery measured using the Quality of Recovery 15 questionnaire. Statistical analysis will determine any superiority of US-TAP and L-TAP versus placebo, and any non-inferiority of L-TAP compared with US-TAP. The latter will only be tested if superiority to placebo is shown. Primary and secondary outcomes will be analysed as intention-to-treat regarding superiority and as intention-to-treat and per protocol regarding non-inferiority. Conclusion This will be the first ever blinded multicentre trial comparing L-TAP, US-TAP and placebo in daily clinical practice. The study has the potential to determine the role of the TAP in minimally invasive colon surgery. Funding A and JC Tvergaards Fond, Helen Rudes Fond, Fru Olga Bryde Nielsens Fond, Aage og Johanne Louis-Hansen Fond, Medicine and Treatment Research Fund of the Danish Regions and a Research Grant from Copenhagen University Hospital - North Zealand Hospital. Trial registration ClinicalTrials.gov: NCT04311099.
Assuntos
Laparoscopia , Bloqueio Nervoso , Músculos Abdominais/diagnóstico por imagem , Adulto , Analgésicos Opioides , Colo , Método Duplo-Cego , Humanos , Estudos Multicêntricos como Assunto , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/prevenção & controle , Nervos Periféricos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
A randomized prospective study was conducted in dogs undergoing hemi-laminectomy procedures for Hansen type I disk protrusion to compare postoperative analgesia achieved with topical spinal application of morphine versus saline. An absorbable gelatin sponge was placed in the defect next to the dura and soaked with either preservative-free morphine (0.1 mg/kg) or saline (0.1 ml/kg) just before wound closure. For 48 hours after surgery, dogs were monitored for pain using visual analog and numeric descriptive scales and given rescue analgesia according to study guidelines. A Kaplan-Meier survival analysis revealed that dogs in the morphine group had a longer (13.3 +/- 3.6 hours) duration of postoperative analgesia than those in the control saline group (5.3 +/- 1.8 hours), and dogs in the morphine group also required fewer doses of additional pain medication. Preservative-free morphine administered topically via an absorbable gelatin sponge appears to be a promising method to alleviate postoperative pain in dogs undergoing hemilaminectomy procedures.