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

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 upper 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 the time of hospital discharge (typically within 5 days, according to our hospital 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

• Sunderland S, Yarnold CH, Head SJ, Osborn JA, Purssell A, Peel JK, Schwarz SK. Regional Versus General Anesthesia and the Incidence of Unplanned Health Care Resource Utilization for Postoperative Pain After Wrist Fracture Surgery: Results From a Retrospective Quality Improvement Project. Reg Anesth Pain Med. 2016 Jan-Feb;41(1):22-7. doi: 10.1097/AAP.0000000000000325. PMID 26650425
• Yang ZS, Lai HC, Jhou HJ, Chan WH, Chen PH. Rebound pain prevention after peripheral nerve block: A network meta-analysis comparing intravenous, perineural dexamethasone, and control. J Clin Anesth. 2024 Dec;99:111657. doi: 10.1016/j.jclinane.2024.111657. Epub 2024 Oct 24. PMID 39454286
• Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30. PMID 32472958
• Chung AR, Mather RV, Gutierrez R, Liu R, Leung CFA, Zhang M, Santa Cruz Mercado LA, Houle TT, Bittner EA, Purdon PL. Association of peripheral nerve blocks with increased postoperative pain and opioid use in orthopaedic surgery: a single-centre retrospective cohort study. Br J Anaesth. 2025 Nov;135(5):1286-1296. doi: 10.1016/j.bja.2025.05.030. Epub 2025 Jul 3. PMID 40610285
• Munoz-Leyva F, Cubillos J, Chin KJ. Managing rebound pain after regional anesthesia. Korean J Anesthesiol. 2020 Oct;73(5):372-383. doi: 10.4097/kja.20436. Epub 2020 Aug 10. PMID 32773724
• Touil N, Pavlopoulou A, Barbier O, Libouton X, Gruson D, Gala JL, Lavand'homme P. Factors associated with a reduction in the preventive effect of intravenous dexamethasone on rebound pain after axillary brachial plexus block. Br J Anaesth. 2025 Oct;135(4):1059-1066. doi: 10.1016/j.bja.2025.05.055. Epub 2025 Jul 22. PMID 40701886
• Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31. PMID 33390261
• Singla P, Ye Y, Elkassabany NM, Mariano ER. 'Pain as regional anaesthesia wears off' or 'rebound pain': what's in a name? Anaesthesia. 2025 Jun;80(6):607-611. doi: 10.1111/anae.16583. Epub 2025 Mar 3. No abstract available. PMID 40032279

Идентификаторы

NCT: NCT07666971 · 2026-00307_a

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗