Prevention of Rebound Pain After Orthopaedic Surgery With Peripheral Nerve Block (REBOUND)_part B

Официальное название

Prevention of Rebound Pain After Orthopaedic Surgery With Peripheral Nerve Block: a Single-blinded Randomised Controlled Trial

Обзор

Rebound pain after peripheral nerve blocks reduces the benefits of regional anesthesia and increases opioid consumption. This rebound pain most likely results from suboptimal pain management, as patients receiving a peripheral nerve block are typically not given scheduled opioid doses. Oral Patient Controlled Analgesia (PCA) consists of an oral morphine prescription that allows patients to self-administer doses based on their pain score. This study will compare patients undergoing elective orthopaedic surgery under general anaesthesia or sedation with a peripheral nerve block, receiving oral morphine PCA either with or without additional scheduled oral morphine doses.

Подробное описание

This study contains two parts, one for the upper limb and one for the lower limb. Each part will be published independently.

This registration concerns the lower limb cohort.

Patients from each cohort (upper limb and lower limb) will be randomized into two groups of 25 patients each, for a total enrollment plan of 50 patients per cohort. After written informed consent, patients will be allocated to one of the two groups according to a computer-generated randomization list.

In the control group, morphine will be administered exclusively on demand via oral PCA,based on pain intensity assessed using a numeric rating scale (VAS \> 4). For oral PCA, one10 mg morphine tablet is placed on the patient's bedside table by the nursing staff. When the patients experience pain, they may take the tablet autonomously and subsequently inform the nurse, who then prepares and places a new tablet at bedside for the next potential pain episode. No scheduled or prophylactic opioid administration will be provided in this group. The maximal allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.

In the intervention group, morphine will be administered at predefined regular intervals, starting immediately in the postoperative period in addition to the availability of oral PCA morphine as mentioned above. Scheduled doses of 20mg slow-release oral morphine will be given at fixed 12 hour intervals. Patients will therefore receive regular morphine to ensure continuous baseline analgesia while still having access to an additional tablet via oral PCA in case of breakthrough pain, following the same nursing procedure as in the control group.

In both groups, standardized multimodal analgesia will be provided

The primary objective of this study is to assess and compare the highest pain score within the first 24 postoperative hours between the two groups using the Visual Analog Scale (VAS). The secondary objective is to assess the effect of the intervention on postoperative pain and analgesic outcomes, including morphine consumption, pain scores, need for additional nerve blocks, incidence of chronic pain, duration of analgesia, postoperative side effects, complications, and hospital length of stay.

Вмешательства

• Препарат Morphine provided via oral PCA
  Morphine will be administered according to a scheduled regimen (20mg slow release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS \> 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.
• Препарат Morphine provided via oral PCA + morphine administered at a scheduled regimen
  morphine will be administered according to a scheduled regimen (20mg slow-release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS \> 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.

Первичные конечные точки

• Worst pain score during the first 24 hours after surgery [Срок оценки: 24 hours postoperatively]

Вторичные конечные точки (12)

• Minimal pain score during the first 12 hours after surgery [Срок оценки: 12 hours postoperatively]
• Rebound pain score measured using the Visual Analog Scale (VAS) [Срок оценки: From surgery until 24 hours postoperatively]
• Rest and dynamic pain scores [Срок оценки: At 2, 12, 24, 36, 48, 60, and 72 hours after surgery]
• Incidence of severe pain [Срок оценки: From surgery through 3 months after surgery]
• Persistence of pain [Срок оценки: During the follow-up period from discharge till 4 weeks and 3 months]
• Morphine consumption in the recovery room [Срок оценки: from admission until discharge from the recovery room, up to 2 hours]
• PCA administered morphine consumption at day 1, 2 and 3 [Срок оценки: Day 1, 2 and 3 postoperatively]
• Total administered morphine consumption at day 1, 2, and 3 [Срок оценки: Day 1, 2 and 3 postoperatively]
• Incidence of postoperative nausea and vomiting [Срок оценки: At 2 hours, day 1, day 2 and day 3 postoperatively]
• Incidence of pruritus [Срок оценки: At 2 hours, day 1, day 2 and day 3 postoperatively]
• Incidence of urinary retention requiring bladder catheterisation [Срок оценки: At 2 hours, day 1, day 2 and day 3 postoperatively]
• Hospital length of stay [Срок оценки: At hospital discharge (typically within 5 days, according to our hospital's standard practice)]

Критерии участия

Критерии включения

• Patients scheduled for elective orthopaedic surgery on the upper limb
• Patients scheduled for elective orthopaedic surgery on the lower limb.
• Score ASA I-III; Patients aged over 18 years; Signed informed consent.
• Surgery under general anaesthesia or under sedation

Критерии исключения

• Refusal or inability to understand the informed consent
• Allergy to any of the following medications: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine,sufentanil, ondansetron, or dexamethasone
• Patients with long term opioid treatment
• Bleeding diathesis
• Neurological disorders of the operated limb
• Known renal insufficiency (eGFR <30 mL/min)
• Known hepatic insufficiency (Child-Pugh class B or C);
• Pregnant or breastfeeding women;
• Alcohol dependence syndrome;
• Patients under spinal anaesthesia;
• Patients undergoing amputation procedures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• CHUV, Centre Hospitalier Vaudois — Lausanne

Публикации

• Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688. PMID 25822923
• Wu CL, Badani S, Tedore TR. Peripheral nerve blocks for perioperative analgesia: das Kind mit dem Bade ausschutten...throwing the baby out with the bathwater? Br J Anaesth. 2025 Nov;135(5):1147-1150. doi: 10.1016/j.bja.2025.08.017. Epub 2025 Sep 22. PMID 40987657
• Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11. PMID 26869374
• Makkar JK, Singh NP, Khurana BJK, Chawla JK, Singh PM. Efficacy of different routes of dexamethasone administration for preventing rebound pain following peripheral nerve blocks in adult surgical patients: a systematic review and network meta-analysis. Anaesthesia. 2025 Jun;80(6):704-712. doi: 10.1111/anae.16566. Epub 2025 Feb 10. PMID 39929722
• Hamilton DL. Rebound pain: distinct pain phenomenon or nonentity? Br J Anaesth. 2021 Apr;126(4):761-763. doi: 10.1016/j.bja.2020.12.034. Epub 2021 Feb 5. No abstract available. PMID 33551124
• Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651. PMID 30124544
• Schubert AK, Wiesmann T, Volberg C, Riecke J, Schneider A, Wulf H, Dinges HC. Rebound pain and postoperative pain profile following brachial plexus block compared to general anaesthesia-An observational study. Acta Anaesthesiol Scand. 2023 Nov;67(10):1414-1422. doi: 10.1111/aas.14318. Epub 2023 Aug 29. PMID 37642227
• Henningsen MJ, Sort R, Moller AM, Herling SF. Peripheral nerve block in ankle fracture surgery: a qualitative study of patients' experiences. Anaesthesia. 2018 Jan;73(1):49-58. doi: 10.1111/anae.14088. Epub 2017 Oct 19. PMID 29052225

Идентификаторы

NCT: NCT07666009 · 2026-00307_b

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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