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Verschil in optreden van reboundpijn bij patiënten die een operatie ondergaan onder knieholteblok of enkelblok (CBFR)

Rebound Pain Occurrence in Patients Undergoing Forefoot Bone Surgery Under Popliteal Sciatic Nerve Block or Distal Sensory Ankle Block: a Randomized Clinical Trial

This single-center, prospective, randomized controlled trial compared rebound pain (RP) occurrence following popliteal sciatic nerve block versus ankle block in patients undergoing elective forefoot bone surgery.

Patients were randomized to receive one of the two ultrasound-guided, single-injection peripheral nerve block techniques, combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion.

The primary objective was to compare RP incidence between the two block techniques. Secondary exploratory objectives included assessing postoperative pain trajectories and perioperative changes in skin temperature and tissue oxygen saturation as indirect indicators of local vasomotor and/or inflammatory responses.

Rebound pain was operationally defined as initially mild postoperative pain (NRS <4 at post-anesthesia care unit discharge), followed by severe pain (NRS ≥7) in the context of block resolution, typically described within 12-24 hours after block resolution. The exact interval between sensory recovery and severe pain onset was not systematically recorded.

Studie Overzicht

Gedetailleerde beschrijving

This prospective, randomized, single-center controlled trial compared popliteal sciatic nerve block with ankle block in patients undergoing elective forefoot bone surgery. Participants were randomly allocated in a 1:1 ratio to either regional anesthetic technique, combined with standardized general anesthesia.

All peripheral nerve blocks were performed under ultrasound guidance before surgery using ropivacaine 0.5% with adrenaline (1:400,000) and clonidine (75 µg). Ankle blocks targeted the nerves supplying the surgical territory, while popliteal sciatic nerve blocks were supplemented by saphenous nerve blockade when required.

Before recruitment, the general anesthesia protocol was modified from the initially registered regimen involving sevoflurane maintenance to propofol target-controlled infusion for both induction and maintenance. This modification aimed to standardize anesthetic management and limit potential confounding effects on postoperative pain assessment. Sufentanil was reserved for intraoperative rescue analgesia but was not required. No intravenous ketamine, dexmedetomidine, or dexamethasone was administered.

Perioperative physiological assessments included infrared skin temperature measurements and tissue oxygen saturation monitoring using INVOS near-infrared spectroscopy on the operated and contralateral limbs. The originally planned Periflux measurements were discontinued before recruitment because the local heating required by this technique could interfere with skin temperature assessment. Preoperative hs-CRP and neutrophil-to-lymphocyte ratio measurements were performed, but the originally planned postoperative biomarker assessments were not conducted.

Postoperative analgesia was standardized using paracetamol and ibuprofen, with tramadol available as rescue medication. Patients remained hospitalized for approximately 24-48 hours, allowing clinical monitoring during sensory block regression and recovery. Follow-up assessments were conducted during hospitalization and by telephone on postoperative days 4 and 30 and at 3 months.

The study primarily compared rebound pain occurrence between the two regional anesthetic techniques. However, the exact onset of severe pain was not systematically timestamped, preventing reliable reconstruction of the originally registered 24-hour endpoint. The operational assessment and corresponding sensitivity analysis are specified in the Outcome Measures section.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

90

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.

Studie Locaties

      • Brussels, België, 1200
        • Cliniques universitaires Saint-Luc

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

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Any surgery of the bones of the lower limbs performed as part of a PNB associated with general anaesthesia after lower limb bone surgery
  • Patient aged between 18 and 75 years old.

Exclusion Criteria:

  • refusal to participate
  • contraindication to the use of local anesthetics
  • contraindication to the use of general anesthesia
  • contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
  • cognitive disorders
  • inability to answer perioperative questionnaires (language problem).

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: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Popliteal sciatic nerve block

An ultrasound-guided popliteal sciatic nerve block was performed using ropivacaine 0.5% combined with adrenaline (1:400,000) and clonidine (75 μg). The popliteal block generally required 20-30 mL of local anesthetic solution. An additional ultrasound-guided saphenous nerve block was performed when indicated by the surgical territory, with total administered volumes reaching up to 40 mL. The maximum permitted ropivacaine dose was 4 mg/kg, not exceeding 300 mg.

The regional anesthesia technique was combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion (TCI).

Elective forefoot bone surgery under popliteal sciatic nerve

Elective forefoot bone surgery under an ankle block

Ander: Ankle block

An ultrasound-guided ankle block was performed using 15-20 mL of ropivacaine 0.5% combined with adrenaline (1:400,000) and clonidine (75 μg). The block targeted the saphenous, superficial peroneal, deep peroneal, and tibial nerves. The maximum permitted ropivacaine dose was 4 mg/kg, not exceeding 300 mg.

The regional anesthesia technique was combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion (TCI).

Elective forefoot bone surgery under popliteal sciatic nerve

Elective forefoot bone surgery under an ankle block

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of rebound pain following peripheral nerve block resolution
Tijdsspanne: During postoperative hospitalization (approximately 24-48 hours), including the period of sensory block resolution.

Rebound pain was assessed as severe postoperative pain (NRS ≥7) following initially mild pain (NRS <4) at post-anesthesia care unit discharge, in the context of peripheral nerve block resolution. Incidence was compared between popliteal sciatic nerve block and ankle block groups. A sensitivity analysis used the stricter NRS >7 threshold. The exact onset of severe pain was not systematically timestamped; therefore, the originally registered 24-hour endpoint could not be reliably reconstructed.

During postoperative hospitalization (approximately 24-48 hours), including the period of sensory block resolution.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Perioperative changes in skin temperature
Tijdsspanne: Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).

Skin temperature (°C) was measured using infrared thermometry on the operated and contralateral feet before and after peripheral nerve block, at emergence from general anesthesia, and on postoperative day 1. Changes over time and their association with rebound pain occurrence were explored.

Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).
Perioperative changes in tissue oxygen saturation
Tijdsspanne: Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).

Tissue oxygen saturation (%) was measured using near-infrared spectroscopy (INVOS) on the operated and contralateral feet before and after peripheral nerve block, at emergence from general anesthesia, and on postoperative day 1. Changes over time and their association with rebound pain occurrence were explored.

Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).
Preoperative Pain Catastrophizing Scale (PCS) score
Tijdsspanne: Preoperatively, before peripheral nerve block administration.

The Pain Catastrophizing Scale (PCS) was administered preoperatively to assess pain-related catastrophizing. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing. The PCS score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.

Preoperatively, before peripheral nerve block administration.
Preoperative Amsterdam Preoperative Anxiety and Information Scale (APAIS) score
Tijdsspanne: Preoperatively, before peripheral nerve block administration.

The Amsterdam Preoperative Anxiety and Information Scale (APAIS) was administered preoperatively to assess anxiety and information needs related to anesthesia and surgery. The total APAIS score ranges from 6 to 30, with higher scores indicating greater preoperative anxiety and/or information needs. The total score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.

Preoperatively, before peripheral nerve block administration.
Preoperative Central Sensitization Inventory (CSI-9) score
Tijdsspanne: Preoperatively, before peripheral nerve block administration.

The nine-item Central Sensitization Inventory (CSI-9) was administered preoperatively to assess symptoms associated with central sensitization. The total score ranges from 0 to 36, with higher scores indicating a greater burden of symptoms associated with central sensitization. The CSI-9 score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.

Preoperatively, before peripheral nerve block administration.
Preoperative DN4 questionnaire score
Tijdsspanne: Preoperatively, before peripheral nerve block administration.

The Douleur Neuropathique en 4 Questions (DN4) questionnaire was administered preoperatively to assess neuropathic pain characteristics. The total score ranges from 0 to 10, with higher scores indicating more neuropathic pain features. A score of 4 or higher suggests a neuropathic pain component. The DN4 score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.

Preoperatively, before peripheral nerve block administration.
Postoperative DN2 score at day 4
Tijdsspanne: Postoperative day 4.

The Douleur Neuropathique en 2 Questions (DN2) questionnaire was administered on postoperative day 4 to assess neuropathic pain symptoms. The questionnaire comprises seven items derived from the DN4, each scored as present (1) or absent (0). The total score ranges from 0 to 7, with higher scores indicating more neuropathic pain symptoms. Scores were compared between the popliteal sciatic nerve block and ankle block groups.

Postoperative day 4.
Postoperative DN2 score at day 30
Tijdsspanne: Postoperative day 30.

The Douleur Neuropathique en 2 Questions (DN2) questionnaire was administered on postoperative day 30 to assess neuropathic pain symptoms. The questionnaire comprises seven items derived from the DN4, each scored as present (1) or absent (0). The total score ranges from 0 to 7, with higher scores indicating more neuropathic pain symptoms. Scores were compared between the popliteal sciatic nerve block and ankle block groups.

Postoperative day 30.
Postoperative DN2 score at 3 months
Tijdsspanne: 3 months after surgery.

The Douleur Neuropathique en 2 Questions (DN2) questionnaire was administered three months after surgery to assess neuropathic pain symptoms. The questionnaire comprises seven items derived from the DN4, each scored as present (1) or absent (0). The total score ranges from 0 to 7, with higher scores indicating more neuropathic pain symptoms. Scores were compared between the popliteal sciatic nerve block and ankle block groups.

3 months after surgery.
Preoperative high-sensitivity C-reactive protein (hs-CRP) level
Tijdsspanne: Preoperatively, before surgery.

High-sensitivity C-reactive protein (hs-CRP) levels were measured preoperatively (mg/L) as an exploratory marker of baseline systemic inflammation. Values were descriptively compared between the popliteal sciatic nerve block and ankle block groups. Postoperative hs-CRP measurements originally planned in the study protocol were not performed.

Preoperatively, before surgery.
Preoperative neutrophil-to-lymphocyte ratio (NLR)
Tijdsspanne: Preoperatively, before surgery.

The neutrophil-to-lymphocyte ratio (NLR) was calculated from preoperative blood cell counts as an exploratory marker of baseline systemic inflammation. This dimensionless ratio was descriptively compared between the popliteal sciatic nerve block and ankle block groups. Postoperative NLR measurements originally planned in the study protocol were not performed.

Preoperatively, before surgery.

Medewerkers en onderzoekers

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

Onderzoekers

  • Hoofdonderzoeker: Nassim TOUIL, MD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

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 (Werkelijk)

24 april 2023

Primaire voltooiing (Werkelijk)

7 juli 2025

Studie voltooiing (Werkelijk)

7 juli 2025

Studieregistratiedata

Eerst ingediend

17 januari 2023

Eerst ingediend dat voldeed aan de QC-criteria

15 februari 2023

Eerst geplaatst (Werkelijk)

21 februari 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

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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