Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
126
Countries
1
Sites
2
Patients undergoing lumbar arthrodesis
Post-operative morphine consumption after lumbar arthrodesis with and without erector spinae plane block
Key facts
- Sponsor
- CHU De Liege
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 17 Oct 2023 → ongoing
- Decision date (initial)
- 2023-09-19
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Post-operative morphine consumption after lumbar arthrodesis with and without erector spinae plane block
Secondary objectives 1
- Secondary objectives will allow to evaluate complications due to the block and quality of recovery after surgery
Conditions and MedDRA coding
Patients undergoing lumbar arthrodesis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- All genders aged from 18 to 85 years old
- ASA 1 or 2
- Scheduled for lumbar arthrodesis surgery 1 to 3 levels
Exclusion criteria 8
- A BMI <18 or > 35 or weight < 50kg
- Kidney or liver failure
- Uncontrolled hypertension at home or requiring more than 2 anti-hypertensive treatments
- Minimally invasive surgery with unilateral approach, percutaneous or without laminectomy
- Allergy to one or more of the medications used in the study
- Chronic pain (chronic medication and/or presence of a neurostimulator), fibromyalgia, psychiatric disorders, alcoholism and/or chronic use of strong opioids (considered chronic if taking a strong opioid on a daily basis for > 1 week) preoperatively
- A contraindication to a loco-regional anesthesia technique
- Refusal of consent by the patient
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary objective will define wether or not ESPB is effective at reducing opioid consumption, in morphine oral equivalent, during the first 24 hours postoperatively
Secondary endpoints 8
- Analysis of intraoperative parameters (blood pressure, heart rate, Response and State Entropy (RE/SE), Surgical Plethysmographic Index (SPI) at the time of the block, during incision and at extubation.
- Absence of complications related to the block
- Opioid use in the PACU
- Level of drowsiness in PACU (RASS score)
- Pain scores at different time intervals from PACU to hospital discharge
- Length of hospitalization
- Assessment of the quality of postoperative recovery using the QoR-15 score at PCA withdrawal
- Presence of PONV, constipation, pruritus
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Levobupivacaine Fresenius Kabi 5 mg/ml Injektionslösung / Infusionslösung
PRD2054770 · Product
- Active substance
- Levobupivacaine Hydrochloride
- Substance synonyms
- LEVOBUPIVACAINE HCL
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFILTRATION
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB10 — LEVOBUPIVACAINE
- Marketing authorisation
- BE460337
- MA holder
- FRESENIUS KABI NV/SA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Chlorure de sodium 0,9% Fresenius Kabi solvant pour préparation parentérale
PRD2846010 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLVENT FOR PARENTERAL USE
- Route of administration
- INFILTRATION
- Max daily dose
- 40 ml millilitre(s)
- Max total dose
- 40 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- BE 345195
- MA holder
- FRESENIUS KABI NV/SA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 10
Linisol 1 %, oplossing voor injectie
PRD5359606 · Product
- Active substance
- Lidocaine Hydrochloride Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- BE166695
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Etoricoxib AB 60 mg comprimés pelliculés
PRD5266476 · Product
- Active substance
- Etoricoxib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AH05 — -
- Marketing authorisation
- BE506782
- MA holder
- AUROBINDO N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MORPHINE HCl STEROP 10mg/1ml Solution injectable
PRD7571642 · Product
- Active substance
- Morphine Hydrochloride
- Substance synonyms
- MORPHINE HCL, MORPHINI HYDROCHLORIDUM
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 15 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- BE414346
- MA holder
- LABORATOIRES STEROP
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TRADONAL, 100 mg, solution injectable
PRD843320 · Product
- Active substance
- Tramadol Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AX02 — TRAMADOL
- Marketing authorisation
- BE177615
- MA holder
- MYLAN EPD BVBA/SPRL
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sufentanil Mylan 5 Mikrogramm/ml Injektionslösung
PRD2563520 · Product
- Active substance
- Sufentanil
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 0.3 µg/Kg microgram(s)/kilogram
- Max total dose
- 0.3 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH03 — SUFENTANIL
- Marketing authorisation
- BE288547
- MA holder
- MYLAN BV/SRL
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
PRD2070260 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- BE379784
- MA holder
- FRESENIUS KABI NV/SA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD467681 · Product
- Active substance
- Methylprednisolone
- Substance synonyms
- 6-METHYLPREDNISOLONE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- BE061747
- MA holder
- PFIZER S.A. (BELGIUM)
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rocuronium B. Braun 10 mg/ml oplossing voor injectie / infusie
PRD6802825 · Product
- Active substance
- Rocuronium Bromide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 0.6 mg/kg milligram(s)/kilogram
- Max total dose
- 0.6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AC09 — ROCURONIUM BROMIDE
- Marketing authorisation
- BE534880
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Propolipid 1% emulsie voor injectie of infusie
PRD2085571 · Product
- Active substance
- Propofol
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 2 mg/kg milligram(s)/kilogram
- Max total dose
- 2 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- BE279833
- MA holder
- FRESENIUS KABI NV/SA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sévoflurane Baxter 100 %, liquide pour inhalation par vapeur
PRD316650 · Product
- Active substance
- Sevoflurane
- Pharmaceutical form
- INHALATION VAPOUR, LIQUID
- Route of administration
- INHALATION USE
- Max daily dose
- 2 % (V/V) percent volume/volume
- Max total dose
- 2 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AB08 — SEVOFLURANE
- Marketing authorisation
- BE371016
- MA holder
- BAXTER SA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHU De Liege
- Sponsor organisation
- CHU De Liege
- Address
- Avenue De L'hopital 1
- City
- Liege
- Postcode
- 4000
- Country
- Belgium
Scientific contact point
- Organisation
- CHU De Liege
- Contact name
- Dr TRAN Gabriel
Public contact point
- Organisation
- CHU De Liege
- Contact name
- Dr TRAN Gabriel
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 126 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-10-17 | 2023-11-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 19 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2023-504204-28-00_SM1_Protocole | 1 |
| Protocol (for publication) | Protocole 2023-504204-28-00 | 2 |
| Recruitment arrangements (for publication) | Recruitment material ESPBs redacted | 2 |
| Subject information and informed consent form (for publication) | 2023-504204-28-00_SM1_SIS and ICF adults | 1 |
| Subject information and informed consent form (for publication) | SIS and ICF adults redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC levobupivacaine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Levobupivacaine | 1 |
| Synopsis of the protocol (for publication) | 2023-504204-28-00_SM1_Protocole synopsis_DE redacted | 1 |
| Synopsis of the protocol (for publication) | 2023-504204-28-00_SM1_Protocole synopsis_ENG redacted | 1 |
| Synopsis of the protocol (for publication) | 2023-504204-28-00_SM1_Protocole synopsis_FR redacted | 1 |
| Synopsis of the protocol (for publication) | 2023-504204-28-00_SM1_Protocole synopsis_NL redacted | 1 |
| Synopsis of the protocol (for publication) | Protocole synopsis DE 2023-504204-28-00 | 1 |
| Synopsis of the protocol (for publication) | Protocole synopsis DE 2023-504204-28-00 | 2 |
| Synopsis of the protocol (for publication) | Protocole synopsis FR 2023-504204-28-00 | 1 |
| Synopsis of the protocol (for publication) | Protocole synopsis FR 2023-504204-28-00 | 2 |
| Synopsis of the protocol (for publication) | Protocole synopsis_ENG 2023-504204-28-00 | 1 |
| Synopsis of the protocol (for publication) | Protocole synopsis_ENG 2023-504204-28-00 | 2 |
| Synopsis of the protocol (for publication) | Protocole synopsis_NL 2023-504204-28-00 | 1 |
| Synopsis of the protocol (for publication) | Protocole synopsis_NL 2023-504204-28-00 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-19 | Belgium | Acceptable with conditions 2023-06-22
|
2023-09-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-19 | Belgium | Acceptable 2024-08-14
|
2024-09-04 |