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

19. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Sveits
      • Lausanne, Sveits, 1000
        • CHUV, Centre Hospitalier Vaudois
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Scheduled group
Oral morphine administered at predefined regular intervals starting immediately after surgery, with additional access to oral PCA.
Legemiddel: 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.
Andre navn:
  • Sevredol 10mg + slow-release oral morphine 20mg
Aktiv komparator: On-demand group
Oral morphine administered on demand via PCA.
Legemiddel: 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.
Andre navn:
  • Sevredol 10mg

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Worst pain score during the first 24 hours after surgery
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Minimal pain score during the first 12 hours after surgery
Tidsramme: 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
Rebound pain score measured using the Visual Analog Scale (VAS)
Tidsramme: 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
Tidsramme: At 2, 12, 24, 36, 48, 60, and 72 hours after surgery
Rest and dynamic pain scores, measured using a 0-10 Visual Analogue Scale (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
Tidsramme: From surgery through 3 months after surgery
Pain evaluated at >7/10 (VAS), measured using a 0-10 Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
From surgery through 3 months after surgery
Persistence of pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 1, 2 and 3 postoperatively
Total consumption in mg
Day 1, 2 and 3 postoperatively
Incidence of postoperative nausea and vomiting
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Hospital length of stay
Tidsramme: At the time of hospital discharge (typically within 5 days, according to our hospital standard practice)
Duration of hospitalization, measured as the number of days from surgery to hospital discharge. Higher values indicate longer hospital stays.
At the time of hospital discharge (typically within 5 days, according to our hospital standard practice)
Requirement for a new peripheral nerve block
Tidsramme: On postoperative day 1, 2 and 3
Requirement for a new peripheral nerve block
On postoperative day 1, 2 and 3
Duration of analgesia
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

Centre Hospitalier Universitaire Vaudois

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Generelle publikasjoner

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Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

19. juni 2026

Først lagt ut (Faktiske)

24. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-00307_a

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