Evaluation of the efficacy of Sphenopalatine Ganglion Block compared to Scalp Block in Supratentorial Intracranial Surgery : a Non-inferiority, Randomized, Controlled, Double-Blind Trial

2024-512112-22-01 Therapeutic use (Phase IV) Ongoing, recruiting

Start 4 Dec 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 88
Countries 1
Sites 1

Patients undergoing craniotomy for supratentorial mass

The primary objective will be the hemodynamic change observed at the time of placement of the spiked headrest (Mayfield's headrest).

Key facts

Sponsor
Centre hospitalier universitaire 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
4 Dec 2024 → ongoing
Decision date (initial)
2024-09-06
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

The primary objective will be the hemodynamic change observed at the time of placement of the spiked headrest (Mayfield's headrest).

Secondary objectives 1

  1. Secondary objectives will allow us to evaluate the efficacy of the block at other keypoints of neurosurgery (incision, dura-mater incision,...), pain scores at key times and quality of recovery after the surgery

Conditions and MedDRA coding

Patients undergoing craniotomy for supratentorial mass

Regulatory references

Plan to share IPD
Yes
EU CT numberTitleSponsor
2024-512112-22-00 Evaluation of the efficacy of Sphenopalatine Ganglion Block compared to Scalp Block in Supratentorial Intracranial Surgery : a Non-inferiority, Randomized, Controlled, Double-Blind Trial Centre hospitalier universitaire de Liege

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Patients undergoing craniotomy for supratentorial mass
  2. ASA 1-2
  3. All genders
  4. 18-85 years old

Exclusion criteria 8

  1. BMI<18 or >35 or weight <50 kg
  2. Renal Insufficiency (under 45ml/min of GFR)
  3. Liver dysfunction (defined by presence of ascitis or coagulation dysfunction)
  4. Uncontrolled hypertension (more than 160mmHg systolic pressure) at home or requiring more than 2 anti-hypertensive treatments
  5. A hypersensitivity and/or a contraindication to one or more of the medications and/or its excipients 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
  6. A contraindication to a loco-regional anesthesia technique
  7. Pregnancy, breastfeeding or unappropriate contraception use for fertile female subjects (b-HCG will be done for fertile female)
  8. Refusal of consent by the patient

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. hemodynamic change observed at the time of placement of the spiked headrest (Mayfield's headrest).

Secondary endpoints 10

  1. Hemodynamic variation during skin incision, flap and dura mater incision
  2. Analysis of intraoperative parameters (heart rate, blood pressure, Response and State Entropy (RE/SE), Surgical Plethysmographic Index (SPI) at the time of block, incision, craniectomy and dura mater incision.
  3. Absence of complications related to the block (AL toxicity, infection, etc.)
  4. Level of sleepiness in USPA (RASS score)
  5. Pain scores at the different time intervals shown in the table from the PCU to hospital discharge
  6. Morphine use in the PACU and in the hospital ward
  7. Length of hospital stay
  8. Evaluation of QoR15 on D-1, D+1, D+3, D+7
  9. Evaluation of patient satisfaction via the EVAN-G score
  10. Presence of PONV, constipation, pruritus during hospitalization

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Levobupivacaïne Fresenius Kabi 5 mg/ml, solution injectable/ pour perfusion

PRD2054772 · Product

Active substance
Levobupivacaine
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INFILTRATION
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
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

PRD2846011 · Product

Active substance
Sodium Chloride
Pharmaceutical form
SOLVENT FOR PARENTERAL USE
Route of administration
INFILTRATION
Max daily dose
15 ml millilitre(s)
Max total dose
15 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 345204
MA holder
FRESENIUS KABI NV/SA
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 8

Ultiva 5 mg poudre pour solution à diluer pour solution injectable/pour perfusion

PRD5463196 · Product

Active substance
Remifentanil
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INFUSION
Max daily dose
0.03 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.03 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N01AH06 — REMIFENTANIL
Marketing authorisation
BE181921
MA holder
ASPEN PHARMA TRADING LIMITED
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Propofol B. Braun 2 % (20 mg/ml), émulsion injectable ou pour perfusion

PRD5090894 · Product

Active substance
Propofol
Pharmaceutical form
EMULSION FOR INJECTION/INFUSION
Route of administration
IV INFUSION
Max daily dose
10 mg/kg/h milligram(s)/kilogram/hour
Max total dose
10 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
N01AX10 — PROPOFOL
Marketing authorisation
BE369765
MA holder
B.BRAUN MELSUNGEN AG
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Nimbex 2 mg/ml, solution injectable/pour perfusion

PRD5460327 · Product

Active substance
Cisatracurium Besilate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
0.2 mg/kg milligram(s)/kilogram
Max total dose
0.2 mg/kg milligram(s)/kilogram
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
M03AC11 — CISATRACURIUM
Marketing authorisation
BE174711
MA holder
ASPEN PHARMA TRADING LIMITED
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
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
120 mg milligram(s)
Max total dose
120 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

Solu-Medrol S.A.B. (= Sine Alcohol Benzylicus) Act-O-Vial 125 mg Poudre et solvant pour solution injectable (méthylprednisolone)

PRD467681 · Product

Active substance
Methylprednisolone
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
IV INFUSION
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.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Linisol 1 %, solution injectable

PRD5359608 · Product

Active substance
Lidocaine Hydrochloride Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
50 mg milligram(s)
Max total dose
50 mg milligram(s)
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

Paracetamol Fresenius Kabi 10 mg/ml solution pour perfusion

PRD2070264 · Product

Active substance
Paracetamol
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
ORAL USE
Max daily dose
4 g gram(s)
Max total dose
4 g gram(s)
Max treatment duration
1 Week(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

Etoricoxib AB 60 mg filmomhulde tabletten

PRD5266474 · Product

Active substance
Etoricoxib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
120 mg milligram(s)
Max total dose
240 mg milligram(s)
Max treatment duration
2 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

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre hospitalier universitaire de Liege

10 Total trials 4 Recruiting 4 Ended
Academic / Non-commercial
Sponsor organisation
Centre hospitalier universitaire de Liege
Address
Avenue De L'hopital 1
City
Liege
Postcode
4000
Country
Belgium

Scientific contact point

Organisation
Centre hospitalier universitaire de Liege
Contact name
Dr TRAN Gabriel

Public contact point

Organisation
Centre hospitalier universitaire de Liege
Contact name
Dr TRAN Gabriel

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 88 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Ongoing, recruiting
Centre hospitalier universitaire de Liege
Anesthesiology, Avenue De L'hopital 1, 4000, Liege

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2024-12-04 2025-02-06

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-17 Belgium Acceptable
2024-09-05
 2024-09-06

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