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

18 juni 2026 bijgewerkt door: Eric Albrecht, Centre Hospitalier Universitaire Vaudois

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Zwitserland
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Zwitserland, 1000
        • CHUV, Centre Hospitalier Vaudois
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Scheduled group
Oral morphine administered at predefined regular intervals starting immediately after surgery, with additional access to oral PCA.
Geneesmiddel: 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.
Actieve vergelijker: On-demand group
Oral morphine administered on demand via PCA.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Worst pain score during the first 24 hours after surgery
Tijdsspanne: 24 hours postoperatively
Highest postoperative pain score during the first 24 hours after surgery, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
24 hours postoperatively

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Minimal pain score during the first 12 hours after surgery
Tijdsspanne: 12 hours postoperatively
Lowest postoperative pain score during the first 12 hours after surgery, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
12 hours postoperatively
Persistence of pain
Tijdsspanne: During the follow-up period from discharge till 4 weeks and 3 months
Incidence of persistent pain at 4 weeks and chronic pain at 3 months
During the follow-up period from discharge till 4 weeks and 3 months
Morphine consumption in the recovery room
Tijdsspanne: from admission until discharge from the recovery room, up to 2 hours
consumption in mg
from admission until discharge from the recovery room, up to 2 hours
PCA administered morphine consumption at day 1, 2 and 3
Tijdsspanne: Day 1, 2 and 3 postoperatively
Consumption in mg administered by PCA
Day 1, 2 and 3 postoperatively
Total administered morphine consumption at day 1, 2, and 3
Tijdsspanne: Day 1, 2 and 3 postoperatively
Total consumption in mg
Day 1, 2 and 3 postoperatively
Incidence of postoperative nausea and vomiting
Tijdsspanne: At 2 hours, day 1, day 2 and day 3 postoperatively
Presence of nausea or vomiting in the postoperative period
At 2 hours, day 1, day 2 and day 3 postoperatively
Incidence of pruritus
Tijdsspanne: At 2 hours, day 1, day 2 and day 3 postoperatively
Presence of pruritus in the postoperative period
At 2 hours, day 1, day 2 and day 3 postoperatively
Incidence of urinary retention requiring bladder catheterisation
Tijdsspanne: At 2 hours, day 1, day 2 and day 3 postoperatively
Urinary retention requiring catheterisation
At 2 hours, day 1, day 2 and day 3 postoperatively
Requirement for a new peripheral nerve block
Tijdsspanne: On postoperative day 1, 2 and 3
Requirement for a new peripheral nerve block
On postoperative day 1, 2 and 3
Duration of analgesia
Tijdsspanne: From the time the block is performed up to 36 hours after surgery
Time between block performance and the first dose of morphine
From the time the block is performed up to 36 hours after surgery
Rebound pain score measured using the Visual Analog Scale (VAS)
Tijdsspanne: From surgery until 24 hours postoperatively
Rebound pain score calculated as the difference between the highest postoperative pain score within the first 24 hours after surgery and the lowest postoperative pain score within the first 12 hours after surgery. Pain intensity is assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher rebound pain scores indicate greater pain rebound
From surgery until 24 hours postoperatively
Rest and dynamic pain scores
Tijdsspanne: At 2, 12, 24, 36, 48, 60, and 72 hours after surgery
Rest and dynamic pain scores, measured using a 0-10 Visual Analogue Score (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
At 2, 12, 24, 36, 48, 60, and 72 hours after surgery
Incidence of severe pain
Tijdsspanne: From surgery through 3 months after surgery
Pain evaluated at >7/10, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
From surgery through 3 months after surgery
Hospital length of stay
Tijdsspanne: At hospital discharge (typically within 5 days, according to our hospital's standard practice)
Duration of hospitalization, measured as the number of days from surgery (baseline) to hospital discharge. Higher values indicate longer hospital stays.
At hospital discharge (typically within 5 days, according to our hospital's standard practice)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Hospitalier Universitaire Vaudois

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

15 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2026

Eerst geplaatst (Werkelijk)

24 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-00307_b

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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