دورية أكاديمية
A Randomized Controlled Trial of Topical Analgesia Posthemorrhoidectomy (TAPH Trial).
| العنوان: | A Randomized Controlled Trial of Topical Analgesia Posthemorrhoidectomy (TAPH Trial). |
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| المؤلفون: | Jin JZ; Department of Surgery, South Auckland Clinical School, The University of Auckland, Auckland, New Zealand., Xia W; Department of Surgery, South Auckland Clinical School, The University of Auckland, Auckland, New Zealand., Gao R; Department of Statistics, The University of Auckland, Auckland, New Zealand., Vandal AC; Department of Statistics, The University of Auckland, Auckland, New Zealand., Weston M; Department of Surgery, Te Whatu Ora Health New Zealand Counties Manukau, Auckland, New Zealand., Israel L; Department of Surgery, Te Whatu Ora Health New Zealand Counties Manukau, Auckland, New Zealand., Connolly A; Department of Surgery, Te Whatu Ora Health New Zealand Counties Manukau, Auckland, New Zealand., Singh PP; Department of Surgery, South Auckland Clinical School, The University of Auckland, Auckland, New Zealand.; Department of Surgery, Te Whatu Ora Health New Zealand Counties Manukau, Auckland, New Zealand., Svirskis D; Department of Surgery, South Auckland Clinical School, The University of Auckland, Auckland, New Zealand.; School of Pharmacy, The University of Auckland, Auckland, New Zealand., Hill A; Department of Surgery, South Auckland Clinical School, The University of Auckland, Auckland, New Zealand.; Department of Surgery, Te Whatu Ora Health New Zealand Counties Manukau, Auckland, New Zealand. |
| المصدر: | Diseases of the colon and rectum [Dis Colon Rectum] 2024 Sep 01; Vol. 67 (9), pp. 1158-1168. Date of Electronic Publication: 2024 Jun 11. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Multicenter Study; Video-Audio Media |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Country of Publication: United States NLM ID: 0372764 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1530-0358 (Electronic) Linking ISSN: 00123706 NLM ISO Abbreviation: Dis Colon Rectum Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Philadelphia. Lippincott |
| مواضيع طبية MeSH: | Lidocaine*/administration & dosage , Lidocaine*/therapeutic use , Hemorrhoidectomy*/adverse effects , Hemorrhoidectomy*/methods , Pain, Postoperative*/drug therapy , Diltiazem*/administration & dosage , Diltiazem*/therapeutic use , Diltiazem*/adverse effects , Administration, Topical* , Anesthetics, Local*/administration & dosage , Anesthetics, Local*/therapeutic use , Metronidazole*/administration & dosage , Metronidazole*/therapeutic use , Pain Measurement* , Hemorrhoids*/surgery, Humans ; Female ; Male ; Middle Aged ; Double-Blind Method ; Adult ; Drug Therapy, Combination ; Treatment Outcome ; New Zealand |
| مستخلص: | Background: Postoperative pain remains the greatest problem after hemorrhoidectomy. Pain is hypothesized to arise from bacterial infection, sphincter spasm, and local inflammation. Objective: This trial was conducted to assess the effects of metronidazole, diltiazem, and lidocaine on posthemorrhoidectomy pain. Design: A double-blinded randomized controlled factorial trial. Settings: This multicenter trial was conducted in Auckland, New Zealand. Patients: A total of 192 participants were randomly assigned (1:1:1:1) into 4 parallel arms. Interventions: Participants were randomly assigned into 1 of 4 groups receiving topical treatment with 10% metronidazole, 10% metronidazole + 2% diltiazem, 10% metronidazole + 4% lidocaine, or 10% metronidazole + 2% diltiazem + 4% lidocaine. Participants were instructed to apply treatment to the anal verge 3 times daily for 7 days. Main Outcome Measures: The primary outcome was pain on the visual analog scale on day 4. The secondary outcomes included analgesia usage, pain during bowel movement, and functional recovery index. Results: There was no significant difference in the pain and recovery scores when diltiazem or lidocaine was added to metronidazole (score difference between presence and absence of diltiazem in the formulation: -3.69; 95% CI, -13.3 to 5.94; p = 0.46; between presence and absence of lidocaine: -5.67; 95% CI, -15.5 to 3.80; p = 0.24). The combination of metronidazole + diltiazem + lidocaine did not further reduce pain. Secondary analysis revealed a significant difference between the best (metronidazole + lidocaine) and worst (metronidazole + diltiazem + lidocaine) groups in both pain and functional recovery scores. There were no significant differences in analgesic usage, complications, or return to work between the groups. No clinically important adverse events were reported. The adverse event rate did not change in the intervention groups. Limitations: Topical metronidazole was used in the control group rather than a pure placebo. Conclusions: There was no significant difference in pain when topical diltiazem, lidocaine, or both were added to topical metronidazole. See Video Abstract . Clinicaltrialsgov Identifier: NCT04276298. Ensayo Controlado Aleatorizado De Analgesia Tpica Posterior a Hemorroidectoma Ensayo Taph: ANTECEDENTES:El dolor postoperatorio sigue siendo el mayor problema tras hemorroidectomía. La hipótesis es que el dolor se debe a infección bacteriana, el espasmo esfínteriano e inflamación local.OBJETIVO:Se realizó un ensayo factorial aleatorizado y controlado para evaluar los efectos del metronidazol, el diltiazem y la lidocaína en el dolor posthemorroidectomía.DISEÑO:Ensayo factorial controlado aleatorizado doble ciego.ESCENARIO:Se realizó un ensayo multicéntrico en Auckland, Nueva Zelanda.PACIENTES:Se aleatorizó a 192 participantes (1:1:1:1) en cuatro brazos paralelos.INTERVENCIONES:Los participantes se asignaron aleatoriamente a uno de los cuatro grupos que recibieron tratamiento tópico con metronidazol al 10% (M), metronidazol al 10% + diltiazem al 2% (MD), metronidazol al 10% + lidocaína al 4% (ML), o metronidazol al 10% + diltiazem al 2% + lidocaína al 4% (MDL). Se indicó a los participantes que lo aplicaran en el margen anal 3 veces al día durante 7 días.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue el dolor en la escala analógica visual en el día 4. Los resultados secundarios incluyeron el uso de analgesia, el dolor al defecar y el índice de recuperación funcional.RESULTADOS:No hubo diferencias significativas en las puntuaciones de dolor y recuperación cuando se añadió diltiazem o lidocaína al metronidazol (diferencia de puntuación entre la presencia y la ausencia de D en la formulación: -3.69; IC del 95%: -13.3; 5.94; p = 0.46; entre la presencia y la ausencia de L: -5.67; IC del 95%: -15.5; 3.80; p = 0.24). La combinación de MDL no redujo más el dolor. El análisis secundario reveló una diferencia significativa entre los grupos mejor (ML) y peor (MDL) tanto en las puntuaciones de dolor como en las de recuperación funcional. No hubo diferencias significativas en el uso de analgésicos, las complicaciones o la reincorporación al trabajo entre los grupos. No se notificaron eventos adversos clínicamente importantes. La tasa de eventosadversos no cambió en los grupos de intervención.LIMITACIONES:Se utilizó metronidazol tópico en el grupo de control, en lugar de un placebo puro.CONCLUSIONES:No hubo diferencias significativas en el dolor cuando se añadió diltiazem tópico o lidocaína, o ambos, al metronidazol tópico. ( Traducción-Dr. Jorge Silva Velazco )Identificador de registro del ensayo clínico:NCT04276298. (Copyright © The ASCRS 2024.) |
| References: | Jin J, Xia W, Connolly A, Hill AG. Symptom-based scoring for haemorrhoidal disease: a systematic review. Colorectal Dis. 2020;22:1518–1527. Jin JZ, Bhat S, Lee K-T, Xia W, Hill AG. Interventional treatments for prolapsing haemorrhoids: network meta-analysis. BJS Open. 2021;5:zrab091. Sammour T. Pain after hemorrhoidectomy.Dis Colon Rectum. 2022;65:951–952. Xia W, Sammour T, Hill A. Pursuit of the painless haemorrhoidectomy: current and future research directions. ANZ J Surg. 2020;90:656–657. Jin J, Unasa H, Bahl P, Mauiliu-Wallis M, Svirskis D, Hill A. Can targeting sphincter spasm reduce post-haemorrhoidectomy pain? A systematic review and meta-analysis. World J Surg. 2023;47:520–533. Xia W, Manning JPR, Barazanchi AWH, Su’a B, Hill AG. Metronidazole following excisional haemorrhoidectomy: a systematic review and meta-analysis. ANZ J Surg. 2018;88:408–414. Xia W, Park B, Otutaha BF, et al. Topical analgesia following excisional haemorrhoidectomy: a systematic review and meta-analysis of randomised controlled trials. Int J Colorectal Dis. 2020;35:181–197. Sammour T, Barazanchi AW, Hill AG; PROSPECT group (Collaborators). Evidence-based management of pain after excisional haemorrhoidectomy surgery: a PROSPECT review update. World J Surg. 2017;41:603–614. Xia W, Barazanchi AWH, MacFater WS, et al. Topical versus oral metronidazole after excisional hemorrhoidectomy: a double-blind randomized controlled trial. Dis Colon Rectum. 2022;65:1362–1372. Castro I, Carvalho P, Vale N, Monjardino T, Mourão J. Systemic anti-inflammatory effects of intravenous lidocaine in surgical patients: a systematic review and meta-analysis. J Clin Med. 2023;12:3772. Abramowitz L, Bouchard D, Siproudhis L, et al. Psychometric properties of a questionnaire (HEMO-FISS-QoL) to evaluate the burden associated with haemorrhoidal disease and anal fissures. Colorectal Dis. 2019;21:48–58. Rørvik HD, Styr K, Ilum L, et al. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: new tools to evaluate symptoms and health-related quality of life in hemorrhoidal disease. Dis Colon Rectum. 2019;62:333–342. Wong J, Tong D, De Silva Y, Abrishami A, Chung F. Development of the functional recovery index for ambulatory surgery and anesthesia. Anesthesiology. 2009;110:596–602. Kleif J, Waage J, Christensen KB, Gögenur I. Systematic review of the QoR-15 score, a patient-reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018;120:28–36. van Buuren S, Groothuis-Oudshoorn K. mice: Multivariate imputation by chained equations in R. J Stat Softw. 2011;45:1–67. Bates D, Mächler M, Bolker B, Walker S. Fitting linear mixed-effects models using lme4.J Stata Softw. 2014;67:1–48. Rubin DB. Multiple Imputation for Survey Nonresponse. New York: Wiley, 1987. Jonas-Obichere M, Scholefield JH, Acheson A, Mundey M, Tyler H, Wilson VG. Comparison of the effects of nitric oxide donors and calcium channel blockers on the intrinsic myogenic tone of sheep isolated internal anal sphincter. Br J Surg. 2005;92:1263–1269. Xia W, MacFater HS, MacFater WS, et al. Local anaesthesia alone versus regional or general anaesthesia in excisional haemorrhoidectomy: a systematic review and meta-analysis. World J Surg. 2020;44:3119–3129. Shiau JM, Hung KC, Chen HH, Chen WH, Wu YH, Tseng CC. Combination of topical EMLA with local injection of lidocaine: superior pain relief after Ferguson hemorrhoidectomy. Clin J Pain. 2007;23:586–590. |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04276298 |
| المشرفين على المادة: | 98PI200987 (Lidocaine) EE92BBP03H (Diltiazem) 0 (Anesthetics, Local) 140QMO216E (Metronidazole) |
| تواريخ الأحداث: | Date Created: 20240613 Date Completed: 20240809 Latest Revision: 20240809 |
| رمز التحديث: | 20240812 |
| DOI: | 10.1097/DCR.0000000000003419 |
| PMID: | 38871679 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1530-0358 |
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| DOI: | 10.1097/DCR.0000000000003419 |